The Measuring Instrument Regulations, 2006

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,969, 15 ta’ Settembru, 2006

L.N. 221 of 2006

THE METROLOGY ACT

(CAP. 454)

The Measuring Instrument Regulations, 2006

IN exercise of the powers conferred by article 19 of the Metrology

Act, the Minister for Competitiveness and Communications, acting on

the advice of the Malta Standards Authority, has made the following

regulations>-

(1) The title of these regulations is the Measuring Instrument Citation and

commencement.

Regulations, 2006.

(2) These regulations shall come into force on the 30 th

October, 2006, hereinafter referred to as the effective date provided

that sub-regulations 4(3) to 4(13) shall remain in-force up to and not

later than 30 th October, 2016.

For the purposes of these regulations the following definitions Definitions.

shall apply>

“active electrical energy meter” has the same meaning given

in Schedule XII hereto<

“area measuring instrument” is a dimensional measuring

instrument and has the same meaning given in Schedule XVIII

hereto<

“automatic weighing instrument” has the same meaning given

in Schedule XV hereto<

“automatic catchweigher” is an automatic weighing

instrument and has the same meaning given in Schedule XV hereto<

“automatic checkweigher” is an automatic weighing

instrument and has the same meaning given in Schedule XV hereto<

“automatic gravimetric filling instrument” is an automatic

weighing instrument and has the same meaning given in Schedule

XV hereto<

“authorised representative” means a natural or legal person

who is established within the Community and authorised by a

manufacturer, in writing, to act on his behalf for specified tasks

within the meaning of these regulations<

“barge” has the same meaning as “bunker barge” has in the

Dangerous Cargo Ships, Marine Terminals And Facilities And

Bunkering Regulations, 1996<

“capacity serving measure” is a material measure and has the

same meaning given in Schedule XVII hereto<

“the Commission” means the European Commission<

“the Community” means the European Community<

“Consumer and Industrial Goods Directorate” means the

Consumer and Industrial Goods Directorate of the Malta Standards

Authority, as established by virtue of the Malta Standards Authority

(Establishment of Directorates) Order, 2000<

“continuous totaliser” is an automatic weighing instrument

and has the same meaning given in Schedule XV hereto<

“dimensional measuring instrument” has the same meaning

given in Schedule XVIII hereto.

“discontinuous totaliser” is an automatic weighing instrument

and has the same meaning given in Schedule XV hereto<

“distribution terminal” means a site that stores and distributes

liquid fuel<

“Enemalta Corporation” means the Enemalta Corporation as

established by the Enemalta Act<

“exhaust gas analysers” has the same meaning as given in

Schedule XIX<

“fuel dispenser” means a measuring system for the refuelling

of motor vehicles, small boats and small aircraft<

“gas meter” and “volume conversion device” have the same

meanings as given in Schedule XI hereto<

“harmonised standard” means a technical specification

adopted by CEN, CENELEC or ETSI or jointly by two or all of

these organisations, at the request of the Commission pursuant to

Directive 98#34#EC of the European Parliament and of the Council

of 22 June 1998 laying down a procedure for the provision of

information in the field of technical standards and regulations and

of rules on Information Society services and prepared in accordance

with the General Guidelines agreed between the Commission and

the European standards organisations<

“heat meter” has the same meaning given in Schedule XIII

hereto<

“instrument specific Schedules” means Schedules X to XIX

of these regulations, both inclusive<

“legal metrological control” means the control of the

measurement tasks intended for the field of application of a

measuring instrument, for reasons of public interest, public health,

public safety, public order, protection of the environment, levying

of taxes and duties, protection of the consumers and fair trading<

“length measuring instrument” is a dimensional measuring

instrument and has the same meaning given in Schedule XVIII

hereto<

“liquid fuel” means any liquid fuel, including Liquefied

Petroleum Gas (also known as LPG) except for cryogenic liquids<

“Malta Resources Authority” means the Malta Resources

Authority as established by the Malta Resources Authority Act< Cap. 423.

“Malta Transport Authority” means the Malta Transport

Authority as established by the Malta Transport Authority Act< Cap. 332.

“manufacturer” means a natural or legal person responsible

for the conformity of the measuring instrument with these

regulations with a view to either placing it on the market under his

own name or putting it into use for his own purposes<

“material measures” has the same meaning given in Schedule

XVII hereto<

“material measure of length””is a material measure and has

the same meaning given in Schedule XVII<

“measuring instrument” means any device or system with a

measuring function that is covered by regulation 4 of these

regulations<

“measuring systems for the continuous and dynamic

measurement of quantities (volume or mass) of liquids other than

water” has the same meaning given in Schedule XIV hereto<

“Member State” means a member state of the European

Union<

“Metrology Directorate” shall have the same meaning as the

“Directorate” has in the Act<

“multi dimensional measuring instrument” is a dimensional

measuring instrument and has the same meaning given in Schedule

XVIII hereto<

“normative document” means a document containing

technical specifications adopted by the OIML, subject to the

procedure stipulated in Article 16(1) of the Directive<

“OIML” means the Organisation Internationale de Métrologie

Légal <

“placing on the market” means making available for the first

time in the Community an instrument intended for an end user,

whether for reward or free of charge<

“putting into use” means the first use of an instrument intended

for the end user for the purposes for which it was intended<

“rail weighbridge” is an automatic weighing instrument and

has the same meaning given in Schedule XV hereto<

“road tanker” means a vehicles the primary use of which is to

carry liquid fuel<

“sub-assembly” means a hardware device, mentioned as such

in the specific schedules, that functions independently and makes

up a measuring instrument together with other sub-assemblies with

which it is compatible, or with a measuring instrument with which

it is compatible<

“taximeter” has the same meaning given in Schedule XVI

hereto<

“water meter” has the same meaning given in Schedule X

hereto<

“Water Services Corporation” means the Water Services

Corporation as established by the Water Services Corporation Act. Cap. 355.

(1) These regulations transpose directive 2004#22#EC of the General scope.

European Parliament and of the Council of the 31 st March 2002 on

Measuring Instruments 1 , hereinafter referred to as the Directive, other

than the specific requirements on the putting to use of measuring

instruments.

(2) The Method for Designating Conformity Assessment

Bodies Regulations, 2003, as applied to these regulations, sets out the L.N. 136 of 2003.

conditions and methods for the recognition of competence and the

subsequent approval of notified bodies.

(1) These regulations shall apply to the following devices Scope and

applicability.

and systems with a measuring function>

(a) water meters intended for the measurement of volumes

of clean, cold or heated water in residential, commercial and light

industrial use<

(b) gas meters and volume conversion devices intended for

residential, commercial and light industrial use<

(c) active electrical energy meters intended for residential,

commercial and light industrial use<

(d) heat meters intended for residential, commercial and

light industrial use<

(e) measuring systems for the continuous and dynamic

measurement of quantities (volume or mass) of liquids other than

water<

(f) automatic weighing instruments intended to determine

the mass of a body by using the action of gravity on that body<

(g) taximeters<

(h) material measures<

(i) dimensional measuring instruments<

OJ No. L 135, page 1, 30.04.2004

(j) exhaust gas analysers intended for the inspection and

professional maintenance of motor vehicles in use>

Provided that they either

(a)

have a legal metrological function,

(b)

or bear the markings as described in sub-regulation 9(1)

hereto.

(2) The following shall be regarded as having a legal

metrological function>

(a) water meters intended for use in trade for the supply of

water from ‘constant supplies’ with in the meaning of the Water

Supply Regulations, 1948<

(b) gas meters and volume conversion devices intended for

use in trade for the supply of fuel gas<

(c) active electrical energy meters intended for use in trade

for the supply of current with in the meaning of the Electricity

Supply Regulations and Rules, 1939<

(d) heat meters intended for use for trade for the supply of

heat to residential, commercial and light industry premises<

(e) measuring systems for the continuous and dynamic

measurement of quantities of liquid other than water intended for

use for trade for the supply of liquid fuel from fuel dispensers<

(f) measuring systems for the continuous and dynamic

measurement of quantities of liquid other than water intended for

use for trade for the supply of liquid fuel from road tankers<

(g) measuring systems for the continuous and dynamic

measurement of quantities of liquid other than water intended for

use for trade for the supply of liquid fuel from barges at sea to

tanks on land<

(h) measuring systems for the continuous and dynamic

measurement of quantities of liquid other than water intended for

trade and#or the levying of taxes on the liquid fuel delivered for

the inland market from distribution terminals as designated by the

Malta Resources Authority<

(i) automatic catchweighers, automatic checkweighers,

automatic gravimetric filling instruments, discontinuous totalisers,

continuous totalisers and rail weighbridges intended for use for

trade<

(j) taximeters referred to in Part V of the Motor Vehicles

(Weights, Dimensions and Equipment) Regulations, 2003<

L.N. 162 of 2003.

(k) material measurements of length, other than dipsticks

and dip tapes, intended for the use in trade namely of measures of

1 centimetre,

1 decimetre,

0.5 metre,

1 metre,

1.5 metres,

2 metres,

3 metres,

5 metres,

10 metres,

20 metres,

30 metres, and

50 metres

for a purpose as may be designated by the Minister<

(l) material measurements of length, namely dipsticks and

diptapes, intended for the use in trade or levying taxes namely of

measures of

1 centimetre,

1 decimetre,

0.5 metre,

1 metre,

1.5 metres,

2 metres,

3 metres,

5 metres,

10 metres,

20 metres,

30 metres, and

50 metres

for the purpose of manual depth measurement of a liquid fuel in a

stationary storage tank<

(m) capacity serving measures intended for use for trade,

namely measures of

5 millilitres,

10 millilitres,

20 millilitres,

25 millilitres,

50 millilitres,

100 millilitres,

125 millilitres,

150 millilitres,

175 millilitres,

200 millilitres,

250 millilitres,

500 millilitres,

1 litre,

2 litres,

2.5 litres,

5 litres and

10 litres<

(n) multi-dimensional measuring instruments for the

purpose of calculating charges for postage, or freight<

(o) length measuring instruments intended for use for trade<

(p) exhaust gas analysers intended for use for the protection

of the environment and public health.

(3) These regulations shall not apply to a cold water meter>

(a) either in respect of a pattern of which the EEC pattern

approval was granted or extended before 30 th October, 2006 and

which fulfils the provisions of the Cold Water Meters Regulations,

2002 or other provisions in any other Member State which

implement Directive 75#33#EEC and which bears a mark of EEC

initial verification or of EEC partial verification, which was affixed

under the Measuring Instrument Regulations, 2002, or by any other

member state<

(b) or which has been manufactured and verified pursuant

to a pattern approved by the Water Services Corporation before

30 th October, 2006.

(4) These regulations shall not apply to a gas meter or a

volume conversion devices intended for use with such a meter>

(a) either in respect of a pattern of which the EEC pattern

approval was granted or extended before 30 th October, 2006 and

which fulfils the provisions of the Gas Volume Meters Regulations, L.N. 404 of 2002.

2002 or other provisions in any other Member state which

implement Directive 71#318#EEC and which bears a mark of EEC

initial verification or of EEC partial verification, which was affixed

under the Measuring Instrument Regulations, 2002, or by any other L.N. 395 of 2002.

Member State<

(b) or which has been manufactured and verified with

respect to a pattern approved pursuant to OIML R 6 before the 30 th

October, 2006.

(5) These regulations shall not apply to an electrical energy

meter>

(a) either in respect of a pattern of which the EEC pattern

approval was granted or extended before 30 th October, 2006 and

which fulfils the provisions of the Electrical Energy Meters

Regulations, 2002 or other provisions in any other Member State L.N. 405 of 2002.

which implement Directive 76#891#EEC and which bears a mark

of EEC initial verification or of EEC partial verification, which

was affixed under the Measuring Instrument Regulations, 2002, L.N. 395 of 2002.

or by any other member state<

(b) or which has been manufactured and verified pursuant

to a pattern approved by the Enemalta Corporation before the 30 th Cap. 355.

October 2006.

(6) These regulations shall not apply to a measuring system

for the continuous and dynamic measurement of liquid fuel>

(a) either in respect of a pattern of which the EEC pattern

approval was granted or extended before 30 th October, 2006 and

which fulfils the provisions of the Volumetric Meters for Liquids

other than Water Regulations, 2002, Ancillary Equipment for L.N. 401 of 2002.

Volumetric Meters Regulations, 2002, and Measuring Systems L.N. 402 of 2002.

for liquids other than Water Incorporating Volumetric Meters

Regulations, 2002, or other provisions in any other Member State L.N. 403 of 2002.

which implement Directives 71#319#EEC, 71#348#EEC

and71#313#EEC, and< which bears a mark of EEC initial verification

or of EEC partial verification, which was affixed under the

Measuring Instrument Regulations, 2002, or by any other Member L.N. 395 of 2002.

State<

(b) or which has been manufactured and verified with

respect to a pattern approved pursuant to OIML R 117 before the

30 th October, 2006.

(7) These regulations shall not apply to an automatic

weighing instrument

(a) either in respect of a pattern of which the EEC pattern

approval was granted or extended before the 30 th October, 2006

and which fulfils the provisions of the Continuous Totalising

Weighing machines attached to Converyor Belt Regulations, 2002

or other provisions in any other Member state which implement

Directive 75#410#EEC and which bears a mark of EEC initial

verification or of EEC partial verification, which was affixed under

the Measuring Instrument Regulations, 2002, or by any other

member state<

(b) or in respect of a pattern of which the EEC pattern

approval was granted or extended before 30 th October, 2006 and

which fulfils the provisions of the Automatic Checkweighing and

Weight Grading machines Regulations, 2002 or other provisions

in any other Member state which implement Directive

78#1031#EEC and which bears a mark of EEC initial verification

or of EEC partial verification, which was affixed under the

Measuring Instrument Regulations, 2002, or by any other Member

State<

(c) or which has been manufactured and verified with

respect of a pattern approved pursuant to OIML recommendations

as follows>

(i) for continuous totalisers, OIML R 50-1 applies<

(ii) for automatic catchweigher, OIML R 51-1 applies<

(iii) for automatic gravimetric filling instrument OIML

R 61-1 applies<

(iv) for rail weigh bridges OIML R 106-1 applies>

Provided such an approval has been granted before the

30 th October, 2006.

(8) These regulations shall not apply to a taxi meter >

(a) either in respect of a pattern of which the EEC pattern

approval was granted or extended before 30 th October, 2006 and

which fulfils the provisions of the Taximeter Regulations, 2002 or

other provisions in any other Member state which implement

Directive 77#95#EEC and< which bears a mark of EEC initial

verification or of EEC partial verification, which was affixed under

the Measuring Instrument Regulations, 2002, or by any other L.N. 395 of 2002.

Member State<

(b) or in respect of a pattern approved by the Malta Cap. 332.

Transport Authority before the 30 th October, 2006.

(9) These regulations shall not apply to a material measure

of length, including dip tapes,>

(a) either in respect of a pattern of which the EEC pattern

approval was granted or extended before 30 th October, 2006 and

which fulfils the provisions of the Material Measures of Length

Regulations, 2002 or other provisions in any other Member State L.N. 406 of 2002.

which implement Directive 73#362#EEC and which bears a mark

of EEC initial verification or of EEC partial verification, which

was affixed under the Measuring Instrument Regulations, 2002, L.N. 395 of 2002.

or by any other Member State<

(b) or which has been manufactured and verified with

respect to a pattern approved pursuant to OIML R 35- EN before

the 30 th October, 2006.

(10) These regulations shall not apply to capacity serving

measures which has been manufactured and verified with respect to a

pattern approved pursuant to OIML recommendations R 29 before the

30 th October, 2006.

(11) These regulations shall not apply to a multi-dimensional

measuring instrument which has been manufactured and verified with

respect to a pattern approved pursuant to OIML recommendations R

129 before the 30 th October, 2006.

(12) These regulations shall not apply to a length measuring

instrument which has been manufactured and verified with respect of a

pattern approved pursuant to OIML recommendations R 66 before the

30 th October, 2006.

(13) These regulations shall not apply to an exhaust gas

analyser which has been manufactured and verified with respect of a

pattern approved by the Malta Transport Authority before the 30 th

October, 2006.

(14) These regulations shall not apply to a measuring

instrument which is presented at trade fairs, exhibitions, demonstrations,

and the like, and is not in conformity with these regulations< provided

that a visible sign clearly indicates that the measuring instrument in

question does not comply with the provisions of these regulations and

that the instrument shall not be placed on the market or put into use,

until brought into conformity with these regulations by the manufacturer.

(15) Regulations 10 and 11 hereto shall apply to all devices

and systems with a measuring function mentioned in sub-regulations

4(1)(a) to 4(1)(j). This is without prejudice to sub-regulations 4(1) to

4(13) hereto.

(16) Notwithstanding the fact that measuring instruments

may fall within the scope of the Electromagnetic Compatibility

Regulations, 2002, which transpose Council Directive 89#336#EEC of

the 3 rd May 1989 on the approximation of the laws of the Member States

relating to electromagnetic compatibility, that equipment shall be subject

only to these regulations, to the exclusion of all others for the purpose

of electromagnetic immunity in the sense of the Electromagnetic

Compatibility Regulations, 2002>

Provided that the Electromagnetic Compatibility Regulations,

2002 shall continue to apply with regard to emission requirements.

(1) (a) A measuring instrument shall meet the essential

requirements laid down in Schedule I hereto and in the relevant

instrument-specific Schedules.

(b) The instrument specific schedules shall apply to

measuring instruments as follows>

(i) Schedule X shall apply to water meters only<

(ii) Schedule XI shall apply to gas meters and volume

conversion devices intended for use with such meters, only<

(iii) Schedule XII shall apply to active electrical energy

meters only<

(iv) Schedule XIII shall apply to heat meters only<

(v) Schedule XIV shall apply to measuring systems for the

continuous and dynamic measurement of quantities (volume or

mass) of liquids other than water only<

(vi) Schedule XV shall apply to automatic weighing

instruments (namely automatic catchweighers, automatic

checkweighers, automatic gravimetric filling instruments,

continuous totalisers, discontinuous totalisers, and rail

weighbridges) only<

(vii) Schedule XVI shall apply to taximeters only<

(viii) Schedule XVII shall apply to material measures

(namely material measures of length and capacity serving

measures) meters only<

(ix) Schedule XVIII shall apply to dimensional measuring

instruments (namely length measuring instruments, area measuring

instruments and multi-dimensional measuring instruments) only<

(x) Schedule XIX shall apply to exhaust gas analysers only.

(2) Any information referred to in the Schedule I or the

instrument specific Schedules, and which is needed for the correct use

of the measuring instrument, shall be in English or Maltese, with both

languages having equal importance for the purposes of this sub-

regulation.

(3) The conformity of a measuring instrument with the

essential requirements shall be assessed in accordance with regulation

7 hereto.

(4) Where specific schedules exist laying down the essential

requirements for sub-assemblies, the provisions of these regulations

shall apply mutatis mutandis to such sub-assemblies.

(5) Sub-assemblies and measuring instruments may be

assessed independently and separately for the purpose of establishing

conformity.

(1) The placing on the market or putting into use of any Placing on the

market and putting

measuring instrument shall not be impeded for reasons covered by these to use.

regulations if they carry CE mark and supplementary metrology marking

in terms of regulation 9 hereto.

(2) Measuring instruments shall be placed on the market

and or put into use only if they satisfy the requirements of these

regulations.

(3) No measuring instrument shall be put to use in a climatic

environment that it was not intended for. Where climatic environment

has the same meaning as in Schedule I hereto.

(1) (a) Conformity assessment of a measuring instrument

with the relevant essential requirements shall be carried out by the

application, at the choice of the manufacturer, of one of the conformity

assessment procedures listed in the instrument-specific Schedules hereto.

The manufacturer shall provide, where appropriate, technical

documentation for specific instruments or groups of instruments as set

out in regulation 8 hereto.

(b) The conformity assessment modules making up the

procedures are described in Schedules II to IXa. The correlation of the

type of module # procedure with the corresponding Schedule is shown

in Schedule XXI.

(2) (a) Records and correspondence relating to conformity

assessment shall either be drawn up in the official language or languages

of the Member State where the notified body carrying out the Conformity

assessment procedures is established, or in a language accepted by that

body.

(b) (a)

The official languages in Malta are Maltese

and English.

(1) The technical documentation shall render the design,

manufacture and operation of the measuring instrument intelligible and

shall permit an assessment of its conformity with the appropriate

requirements of these regulations.

(2) The technical documentation shall be sufficiently

detailed to ensure>

(a)

the definition of the metrological characteristics,

(b) the reproducibility of the metrological performances of

produced instruments when properly adjusted using appropriate

intended means, and

(c)

the integrity of the instrument.

(3) The technical documentation shall include insofar as

relevant for assessment and identification of the type or instrument>

(a)

a general description of the instrument<

(b) conceptual design and manufacturing drawings and plans

of components, sub-assemblies, circuits, etc<

(c) manufacturing procedures to ensure consistent

production<

(d) if applicable, a description of the electronic devices with

drawings, diagrams, flow diagrams of the logic and general

software information explaining their characteristics and operation<

(e) descriptions and explanations necessary for the

understanding of paragraphs (b), (c) and (d) above, including the

operation of the instrument<

(f) a list of the standards or normative documents referred

to in regulation 12, hereto, applied in full or in part<

(g) descriptions of the solutions adopted to meet the essential

requirements where the standards or normative documents referred

to in regulation 12, hereto, have not been applied<

(h) results of design calculations, examinations, etc<

(i) the appropriate test results, where necessary, to

demonstrate that the type and#or instruments comply with>

(1) the requirements of these regulations under

declared rated operating conditions and under specified

environmental disturbances, and

(2) the durability specifications for gas meters, water

meters, heat meters as well as meters for liquids other than

water<

(j) the EC-type examination certificates or EC design

examination certificates in respect of instruments containing parts

identical to those in the design.

(4) The manufacturer shall specify where seals and markings

have been applied.

(5) The manufacturer shall indicate the conditions for

compatibility with interfaces and sub-assemblies, where relevant.

(1) The conformity of a measuring instrument with all the Conformity

marking.

provisions of these regulations shall be indicated by the presence on it

of the “CE” marking and the supplementary metrology marking as

specified in sub-regulations (3) to (7) hereto.

(2) The “CE” marking and supplementary metrology

marking shall be affixed by, or under the responsibility of, the

manufacturer. These markings may be affixed to the instrument during

the fabrication process, if justified.

(3) The “CE” marking shall consist of the symbol “CE”

according to the design laid down Schedule XX. The “CE” marking

shall be at least 5 mm high.

(4) The supplementary metrology marking consists of the

capital letter “M” and the last two digits of the year of its affixing,

surrounded by a rectangle. The height of the rectangle shall be equal to

the height of the “CE” marking. The supplementary metrology marking

shall immediately follow the “CE” marking

(5) The identification number of the notified body concerned

referred to in regulation 10, hereto, if prescribed by the conformity

assessment procedure, shall follow the “CE” marking and supplementary

metrology marking.

(6) (a) When a measuring instrument consists of a set of

devices, not being sub-assemblies, operating together, the markings shall

be affixed on the instrument’s main device.

(b) When a measuring instrument is too small or too

sensitive to carry the “CE” marking and supplementary metrology

marking, the markings shall be carried by the packaging, if any, and by

the accompanying documents required by these regulations.

(7) The “CE” marking and supplementary metrology

marking shall be indelible. The identification number of the notified

body concerned shall be indelible or self destructive upon removal. All

markings shall be clearly visible or easily accessible.

(8) The affixing of markings on a measuring instrument that

are likely to deceive third parties as to the meaning or form of the “CE”

marking and the supplementary metrology marking shall be prohibited.

Any other marking may be affixed on a measuring instrument, provided

that the visibility and legibility of the “CE” marking and the

supplementary metrology marking is not thereby reduced.

(9) Where the measuring instrument is subject to measures

adopted under other Maltese legislation covering other aspects which

require the affixing of the “CE’”marking, the marking shall indicate

that the instrument in question is also presumed to conform to the

requirements of such legislation. In such a case, the publication reference

of the said legislation or its European equivalent as published in the

Official Journal of the European Union, must be given in the documents,

notices or instructions required by the CE legislation and accompanying

the measuring instrument.

(1) Notification of the bodies designated to carry out the Notified bodies.

tasks pertaining to the conformity assessment modules referred to in

regulation 7, hereto, together with the identification numbers given to

them by the Commission, any kind of measuring instrument for which

each body has been designated and in addition, where relevant, the

instrument accuracy classes, the measuring range, the measurement

technology, and any other instrument characteristic limiting the scope

of the notification shall be sent to the Commission and other Member

States.

(2) Such bodies are subject to the Method for Designating

Conformity Assessment Bodies Regulations, 2003. They shall also fulfil L.N. 136 of 2003.

the criteria and obligations set out in regulation 11 hereto.

(a) Bodies that meet the criteria laid down in the standards

issued by the Malta Standards Authority which transpose the

relevant harmonised standards, the references of which have been

published in the Official Journal of the European Union, shall be

presumed to meet the corresponding criteria.

(1) The following criteria shall apply for the designation Criteria to be

satisfied by

of bodies in accordance with regulation 10 hereto>-

designated bodies

and their

obligations.

(a) the body, its director, and staff involved in conformity

assessment tasks shall not be the designer, manufacturer, supplier,

installer or user of the measuring instruments that they inspect,

nor the authorised representative of any of them. In addition, they

shall not be directly involved in the design, manufacture, marketing

or maintenance of the instruments, nor represent the parties engaged

in these activities. The preceding criterion does not, however

preclude in any way the possibility of exchange of technical

information between the manufacturer and the body for the

purposes of conformity assessment<

(b) the body, its director and staff involved in conformity

assessment tasks shall be free from all pressures and inducements,

in particular financial inducements, that might influence their

judgement or the results of their conformity assessment, especially

from persons or groups of persons with an interest in the results of

the assessments<

(c) the conformity assessment shall be carried out with the

highest degree of professional integrity and requisite competence

in the field of metrology. Should the body subcontract specific

tasks, it shall first ensure that the subcontractor meets the

requirements of these regulations, and in particular of this

regulation. The body shall keep the relevant documents assessing

the subcontractor’s qualifications and the work carried out by him

under these regulations at the disposal of the notifying authority<

(d) the body shall be capable of carrying out all the

conformity assessment tasks for which it has been designated,

whether those tasks are carried out by the body itself or on its

behalf and under its responsibility. It shall have at its disposal the

necessary staff and shall have access to the necessary facilities for

carrying out in a proper manner the technical and administrative

tasks entailed in conformity assessment<

(e)

the body’s staff shall have>

(i) sound technical and vocational training, covering

all conformity assessment tasks for which the body was

designated<

(ii) satisfactory knowledge of the rules governing the

tasks which it carries out, and adequate experience of such

tasks<

(iii) the requisite ability to draw up the certificates,

records and reports demonstrating that the tasks have been

carried out<

(f) the impartiality of the body, its director and staff shall

be guaranteed. The remuneration of the body shall not depend on

the results of the tasks it carries out. The remuneration of the

body’s director and staff shall not depend on the number of tasks

carried out or on the results of such tasks<

(g) the body shall take out civil liability insurance unless

its civil liability is covered by the Government of Malta under the

laws of Malta<

(h) The body’s director and staff shall be bound to observe

professional secrecy in terms of all the relevant laws and regulations

regulating professional secrety, inter alia, the Professional Secrecy

Act and the Criminal Code with regard to all information obtained

in the performance of their duties pursuant to these regulations at

all times, except when upon written request by the Consumer and

Industrial Goods Directorate, the body shall provide the said

directorate with all the information so requested without delay.

(2) pursuant to regulations 8 and 9 of the Method for

Designating Conformity Assessment Bodies Regulations, 2003, the L.N. 136 of 2003.

following obligations shall apply to bodies designated in accordance

with regulation 10 hereto>

(a) they shall send to the Consumer and Industrial Goods

Directorate at the end of each four month period the following>

(i) EC-Type examination and design certificates and

their annexes issued by them during that quarter,

(ii) amendments, additions and withdrawals relating

to the documents mentioned in (i) hereto,

(iii) quality system approvals issued by them during

that quarter,

(iv) information on the quality systems refused or with

drawn during that quarter< and

(b) they shall send to the Consumer and Industrial Goods

Directorate evaluations reports with in one month of their request

by the said directorate.

(1) Conformity with the essential requirements referred to Harmonised

standards and

in Schedule I and in the relevant instrument-specific Schedules in respect normative

of a measuring instrument that complies with the elements of the national documents.

standards implementing the European harmonised standard for that

measuring instrument, that correspond to those elements of this European

harmonised standard the references in respect of which have been

published in the Official Journal of the European Union, C series shall

be presumed. References to the national standards shall be published

in the Government Gazette.

(2) Where a measuring instrument complies only in part

with the elements of the national standards referred to in sub-regulation

(1) hereof, conformity with the essential requirements corresponding

to the elements of the national standards with which the instrument

complies shall be presumed.

(3) Conformity with the essential requirements referred to

in Schedule I and in the relevant instrument-specific Schedules in respect

of a measuring instrument that complies with the corresponding parts

of the normative documents and lists, the references in respect of which

have been published in the Official Journal of the European Union, C

series shall be presumed. References to these normative documents

shall be published in the Government Gazette.

(4) Where a measuring instrument complies only in part

with the normative document referred to in the sub-regulation (3) hereto,

conformity with the essential requirements corresponding to the

normative elements with which the instrument complies shall be

presumed.

(5) A manufacturer may choose to use any technical solution

that complies with the essential requirements referred to in Schedule I

and in the relevant instrument-specific Schedules. In addition, to benefit

from the presumption of conformity, the manufacturer must correctly

apply solutions mentioned

(a)

either in the relevant European harmonised standards,

(b) or in the corresponding parts of the normative documents

and lists as referred to in this regulation.

(6) Compliance with the appropriate tests mentioned in sub-

regulations 8(3)(i) hereto shall be presumed if the corresponding test

programme has been performed in accordance with the relevant

documents mentioned in sub-regulations (1) to (5) hereto and if the test

results ensure compliance with the essential requirements.

(1) Where it is established that the ‘CE’ marking and

supplementary metrology marking have been affixed unduly, the

manufacturer or his authorized representative shall be obliged to>

(a) to make the instrument conform as regards those

provisions concerning the “CE” marking and supplementary

metrology marking not covered by sub-regulation 14(1), and

(b) to end the infringement under the conditions imposed

by the Metrology Directorate.

(2) Should the infringement persist all appropriate measures

to restrict or prohibit placing on the market of the instrument in question

or to ensure it is withdrawn from the market or prohibit or restrict its

function of use in accordance with the procedures laid down in regulation

14 hereto shall be taken.

(1) (a) Where it is established that all or part of the Withdrawal and

prohibition form the

measuring instruments of a particular model that bear the “CE” marking market.

and the supplementary metrology marking, when correctly installed and

used in accordance with the manufacturer’s instructions, do not satisfy

the essential requirements relating to metrological performance set out

in these regulations, the Metrology Directorate shall take all appropriate

measures to withdraw these instruments from the market, prohibit or

restrict their further being placed on the market, or prohibit or restrict

their further being used.

(b) The Head shall immediately inform the Consumer

and Industrial Goods Directorate of the Malta Standards Authority of

any such measure, indicating the reason for its decision and in particular,

whether non-conformity is due to>-

(i) failure to satisfy the essential requirements referred to

in regulation 5 of these regulations<

(ii) incorrect application of the standards or normative

documents referred to in regulation 12 of these regulations<

(iii) shortcomings in the standards themselves referred to

in regulation 12 of these regulations.

(c) Information on the systematic or incidental nature

of the non-compliance shall also be supplied.

(2) Where the non-compliance has been established to be

of a systematic nature the Consumer and Industrial Goods Directorate

shall inform the Commission of the measures taken, indicating the

reasons for the decision.

(3) Any decision taken pursuant to these regulations

entailing the withdrawal from the market of a measuring instrument, or

prohibiting or restricting the placing on the market or putting into use

of an instrument, shall state the exact grounds on which it is based. The

decision shall be notified forthwith to the party concerned, who shall at

the same time be informed of the legal remedies available to him and of

the time limits to which such remedies are subject.

(1) The Metrology Directorate shall communicate to the Exchange of

information.

Commission and other member states information on the compliance

of instruments with the provisions of these regulations.

(2) The Consumer and Industrial Goods Directorate shall

communicate to the Commission and other member states information

gathered pursuant to the application of regulation 11(2) of these

regulations.

(3) The Consumer and Industrial Goods Directorate shall

make available for the bodies it had notified to carry out tasks under

these regulations, information deemed necessary and that it has available,

relating to certificates and quality system approvals.

(1) The Hot Water Meters Regulations, 2002 regulations

2002. shall be repealed with effect from the 30 th October 2006.

(2) Any references to the aforementioned repealed

regulations shall be construed as a reference to these regulations.

For regulation 3 of the Continuous Totalising Weighing

2002. machines attached to Conveyor Belt Regulations, 2002 there shall be

substituted the following>

“3. These regulations shall apply to continuous totalising

weighing machines attached to conveyor belts provided an EEC

pattern approval was issued or extended before 30 th October 2006.

These machines are defined in Chapter I, Section 2 of the Annex.”.

For regulation 3 of the Automatic Checkweighing and Weight

2002. Grading Machines regulations, 2002 there shall be substituted the

following>

“3. These regulations shall apply to automatic

checkweighing and weight grading machines provided an EEC

pattern approval was issued or extended before 30 th October 2006.”.

For regulation 3 of the Cold Water Meters regulations, 2002

2002. there shall be substituted the following>

“3. These regulations shall apply to cold water meters, which

are integrating measuring instruments for continuously determining

the volume of water (and no other liquid) passing through them,

and which comprise a measuring device linked to an indicating

device provided an EEC pattern approval was issued or extended

before 30 th October 2006.”.

For regulation 3 of the Volumetric Meters for Liquids other

2002. than Water Regulations, 2002 there shall be substituted the following>

“3. These regulations shall apply to volumetric meters for

liquids other than water in which the liquid causes the movement

of mobile walls of measuring chambers and which permit the

measurement of any volumes provided an EEC pattern approval

was issued or extended before 30 th October 2006.”.

For regulation 3 of the Ancillary Equipment for Volumetric Amends L.N. 402 of

2002. Meters Regulations, 2002 there shall be substituted the following>

“3. These regulations apply to ancillary equipment for

volumetric meters for liquids other than water which is specified

in the Annex hereof provided an EEC pattern approval was issued

or extended before 30 th October 2006.”.

For regulation 3 of the Measuring Systems for Liquids other Amends L.N. 403 of

2002. than Water Incorporating Volumetric Meters Regulations, 2002 there

shall be substituted the following>

“3. These regulations shall apply to measuring systems for

liquids other than water incorporating volumetric meters in which

the liquid causes the movement of mobile walls of measuring

chambers provided an EEC pattern approval was issued or extended

before 30 th October 2006.”.

For regulation 3 of the Gas Volume Meters Regulations, 2002 Amends L.N. 404 of

2002. there shall be substituted the following>

“3. These regulations shall apply to the following gas

volume meters>

(a)

volumetric meters> meters with deformable walls

meters with rotary pistons

(b) non-volumetric meters> turbine meters>

Provided that an EEC pattern approval was issued or extended

before 30 th October 2006.”.

For regulation 3 of the Electrical Energy Meters Regulations, Amends L.N. 405 of

2002. 2002 there shall be substituted the following>

“3. These regulations shall apply to new direct connected

induction meters, with single or multiple tariffs, designed to measure

active energy single-phase or poly-phase current at 50Hz provided an

EEC pattern approval was issued or extended before 30 th October 2006.”.

For regulation 3 of the Material Measures of Length Amends

2002. Regulations, 2002 there shall be substituted the following>

Regulation 3 shall be substituted by the following>

“3. These regulations shall apply to material measures

of length specified in the Annex provided an EEC pattern

approval was issued or extended before 30 th October 2006.”.

For regulation 3 of the Taximeter Regulations, 2002 there

2002. shall be substituted the following>

“3. These regulations shall apply to time-distance meters

called “taximeters” provided an EEC pattern approval was issued

or extended before 30 th October 2006.”.

(1) The following regulations shall be repealed with effect

from the 30 th October, 2016>

Continuous Totalising Weighing machines attached to

Conveyor Belt Regulations, 2002.

Automatic Checkweighing and Weight Grading Machines

Regulations, 2002.

Cold Water Meters regulations, 2002

Volumetric Meters for Liquids other than Water Regulations,

Ancillary Equipment for Volumetric Meters Regulations,

Measuring Systems for Liquids other than Water

Incorporating Volumetric Meters Regulations, 2002.

Gas Volume Meters Regulations, 2002

Electrical Energy Meters Regulations, 2002.

Material Measures of Length Regulations, 2002.

Taximeter Regulations, 2002

(2) Any references to the aforementioned regulations, when

repealed, listed in sub-regulation (1) hereof, shall be construed as a

reference to these regulations.

Schedule I

(Regulation 5)

Essential Requirements

A measuring instrument shall provide a high level of metrological protection in order that

any party affected can have confidence in the result of measurement, and shall be designed

and manufactured to a high level of quality in respect of the measurement technology and

security of the measurement data.

The requirements that shall be met by measuring instruments are set out below and are

supplemented, where appropriate, by specific instrument requirements in the instrument

specific schedules that provide more detail on certain aspects of the general requirements.

The solutions adopted in the pursuit of the requirements shall take account of the intended

use of the instrument and any foreseeable misuse thereof

DEFENITIONS

Measureand

The measurand is the particular quantity subject to measurement.

Influence quantity

An influence quantity is a quantity that is not the measurand but that affects the result of

measurement..

Rated Operating Conditions

The rated operating conditions are the values for the measurand and influence quantities

making up the normal working conditions of an instrument.

Disturbance

An influence quantity having a value within the limits specified in the appropriate

requirement but outside the specified rated operating conditions of the measuring instrument.

An influence quantity is a disturbance if for that influence quantity the rated operating

conditions are not specified.

Critical change value

The critical change value is the value at which the change in the measurement result is

considered undesirable.

Material Measure

A material measure is a device intended to reproduce or supply in a permanent manner

during its use one or more known values of a given quantity

Direct sales

A trading transaction is direct sales if

the measurement result serves as the basis for the price to pay and;

at least one of the parties involved in the transaction related to measurement is a

consumer or any other party requiring a similar level of protection and;

all the parties in the transaction accept the measurement result at that time and

place.

Climatic environments

Climatic environments are the conditions in which measuring instruments may be used. To

cope with climatic differences between the Member States, a range of temperature limits has

been defined.

A utility is regarded as a supplier of electricity, gas, heat or water.

REQUIREMENTS

1. Allowable Errors

Under rated operating conditions and in the absence of a disturbance, the error

of measurement shall not exceed the maximum permissible error (MPE) value

as laid down in the appropriate instrument-specific requirements.

Unless stated otherwise in the instrument-specific schedules, MPE is expressed

as a bilateral value of the deviation from the true measurement value.

Under rated operating conditions and in the presence of a disturbance, the

performance requirement shall be as laid down in the appropriate instrument-

specific requirements.

Where the instrument is intended to be used in a specified permanent

continuous electromagnetic field the permitted performance during the radiated

electromagnetic field-amplitude modulated test shall be within MPE.

The manufacturer shall specify the climatic, mechanical and electromagnetic

environments in which the instrument is intended to be used, power supply and

other influence quantities likely to affect its accuracy, taking account of the

requirements laid down in the appropriate instrument-specific schedules

Climatic environments

The manufacturer shall specify the upper temperature limit and the lower

temperature limit from any of the values in the table below unless otherwise

specified in the instrument specific schedules, and indicate whether the

instrument is designed for condensing or non-condensing humidity as well as

the intended location for the instrument, i.e. open or closed.

Temperature Limits

Upper temperature limit

30°C

40 °C

55°C

70°C

Lower temperature limit

5°C

-10°C

-25°C

-40°C

Mechanical environments are classified into classes M1 to M3 as described

This class applies to instruments used in locations with vibration and

shocks of low significance, e.g. for instruments fastened to light

supporting structures subject to negligible vibrations and shocks

transmitted from local blasting or pile-driving activities, slamming

doors, etc.

This class applies to instruments used in locations with significant or

high levels of vibration and shock, e.g. transmitted from machines

and passing vehicles in the vicinity or adjacent to heavy machines,

conveyor belts, etc.

This class applies to instruments used in locations where the level of

vibration and shock is high and very high, e.g. for instruments

mounted directly on machines, conveyor belts, etc.

(b)

The following influence quantities shall be considered in relation with

mechanical environments

- Vibration;

- Mechanical shock.

Electromagnetic environments are classified into classes E1, E2 or E3 as

described below, unless otherwise laid down in the appropriate instrument-

specific schedules.

This class applies to instruments used in locations with

electromagnetic disturbances corresponding to those likely to be

found in residential, commercial and light industrial buildings.

This class applies to instruments used in locations with

electromagnetic disturbances corresponding to those likely to be

found in other industrial buildings

This class applies to instruments supplied by the battery of a vehicle.

Such instruments shall comply with the requirements of E2 and the

following additional requirements

- voltage reductions caused by energising the starter-motor circuits of

internal combustion engines,

- load dump transients occurring in the event of a discharged battery

being disconnected while the engine is running

(b)

The following influence quantities shall be considered in relation with

electromagnetic environments

Voltage interruptions,

Short voltage reductions,

Voltage transients on supply lines and/or signal lines,

Electrostatic discharges,

Radio frequency electromagnetic fields,

Conducted radio frequency electromagnetic fields on supply lines

and/or signal lines,

Surges on supply lines and/or signal lines.

Other influence quantities to be considered, where appropriate, are

Voltage variation,

Mains frequency variation,

Power frequency magnetic fields,

Any other quantity likely to influence in a significant way the

accuracy of the instrument

When carrying out the tests as envisaged in these regulations, the following

paragraphs apply

Basic rules for testing and the determination of errors

Essential requirements specified in 1.1 and 1.2 shall be verified for each

relevant influence quantity. Unless otherwise specified in the appropriate

instrument-specific schedule, these essential requirements apply when each

influence quantity is applied and its effect evaluated separately, all other

influence quantities being kept relatively constant at their reference value.

Metrological tests shall be carried out during or after the application of the

influence quantity, whichever condition corresponds to the normal operational

status of the instrument when that influence quantity is likely to occur.

Ambient humidity

-

According to the climatic operating environment in which the

instrument is intended to be used either the

damp heat-steady state (non-condensing) or damp heat cyclic

(condensing) test may be appropriate.

-

The damp heat cyclic test is appropriate where condensation is

important or when penetration of vapour will be accelerated by the

effect of breathing. In conditions where non-condensing humidity is

a factor the damp-heat steady state is appropriate.

2. Reproducibility

The application of the same measurand in a different location or by a different

user, all other conditions being the same, shall result in the close agreement of

successive measurements. The difference between the measurement results

shall be small when compared with the MPE.

3. Repeatability

The application of the same measurand under the same conditions of

measurement shall result in the close agreement of successive measurements.

The difference between the measurement results shall be small when compared

with the MPE.

4. Discrimination and Sensitivity

A measuring instrument shall be sufficiently sensitive and the discrimination

threshold shall be sufficiently low for the intended measurement task.

5. Durability

A measuring instrument shall be designed to maintain an adequate stability of

its metrological characteristics over a period of time estimated by the

manufacturer, provided that it is properly installed, maintained and used

according to the manufacturer's instruction when in the environmental

conditions for which it is intended

6. Reliability

A measuring instrument shall be designed to reduce as far as possible the effect

of a defect that would lead to an inaccurate measurement result, unless the

presence of such a defect is obvious.

7. Suitability

A measuring instrument shall have no feature likely to facilitate fraudulent use,

whereas possibilities for unintentional misuse shall be minimal.

A measuring instrument shall be suitable for its intended use taking account of

the practical working conditions and shall not require unreasonable demands of

the user in order to obtain a correct measurement result.

The errors of a utility measuring instrument at flows or currents outside the

controlled range shall not be unduly biased.

Where a measuring instrument is designed for the measurement of values of the

measurand that are constant over time, the measuring instrument shall be

insensitive to small fluctuations of the value of the measurand, or shall take

appropriate action.

A measuring instrument shall be robust and its materials of construction shall be

suitable for the conditions in which it is intended to be used.

A measuring instrument shall be designed so as to allow the control of the

measuring tasks after the instrument has been placed on the market and put into

use. If necessary, special equipment or software for this control shall be part of

the instrument. The test procedure shall be described in the operation manual.

When a measuring instrument has associated software which provides other

functions besides the measuring function, the software that is critical for the

metrological characteristics shall be identifiable and shall not be inadmissibly

influenced by the associated software.

8. Protection against corruption

The metrological characteristics of a measuring instrument shall not be

influenced in any inadmissible way by the connection to it of another device, by

any feature of the connected device itself or by any remote device that

communicates with the measuring instrument.

A hardware component that is critical for metrological characteristics shall be

designed so that it can be secured. Security measures foreseen shall provide for

evidence of an intervention.

Software that is critical for metrological characteristics shall be identified as

such and shall be secured.

Software identification shall be easily provided by the measuring instrument.

Evidence of an intervention shall be available for a reasonable period of time.

Measurement data, software that is critical for measurement characteristics and

metrologically important parameters stored or transmitted shall be adequately

protected against accidental or intentional corruption.

For utility measuring instruments the display of the total quantity supplied or

the displays from which the total quantity supplied can be derived, whole or

partial reference to which is the basis for payment, shall not be able to be reset

during use.

9. Information to be borne by and to accompany the instrument

A measuring instrument shall bear the following inscriptions

-

manufacturer's mark or name;

-

information in respect of its accuracy,

plus, when applicable

-

information in respect of the conditions of use;

-

measuring capacity;

-

measuring range;

-

identity marking;

-

number of the EC-type examination certificate or the EC design

examination certificate;

-

information whether or not additional devices providing

metrological results comply with the provisions of these regulations

on legal metrological control

An instrument of dimensions too small or of too sensitive a composition to

allow it to bear the relevant information shall have its packaging, if any, and the

accompanying documents required by the provisions of these regulations

suitably marked.

The instrument shall be accompanied by information on its operation, unless the

simplicity of the measuring instrument makes this unnecessary. Information

shall be easily understandable and shall include where relevant

-

rated operating conditions;

-

mechanical and electromagnetic environment classes;

-

the upper and lower temperature limit, whether condensation is

possible or not, open or closed location;

-

instructions for installation, maintenance, repairs, permissible

adjustments;

-

instructions for correct operation and any special conditions of use;

-

conditions for compatibility with interfaces, sub-assemblies or

measuring instruments.

Groups of identical measuring instruments used in the same location or used for

utility measurements do not necessarily require individual instruction manuals.

Unless specified otherwise in an instrument-specific schedule, the scale interval

for a measured value shall be in the form 1×10 n , 2×10 n , or 5×10 n , where n is

any integer or zero. The unit of measurement or its symbol shall be shown

close to the numerical value.

A material measure shall be marked with a nominal value or a scale,

accompanied by the unit of measurement used.

The units of measurement used and their symbols shall be in accordance with

the provisions of Community legislation on units of measurement and their

symbols.

All marks and inscriptions required under any requirement shall be clear, non-

erasable, unambiguous and non-transferable.

10. Indication of result

Indication of the result shall be by means of a display or hard copy.

The indication of any result shall be clear and unambiguous and accompanied

by such marks and inscriptions necessary to inform the user of the significance

of the result. Easy reading of the presented result shall be permitted under

normal conditions of use. Additional indications may be shown provided they

cannot be confused with the metrologically controlled indications.

In the case of hard copy the print or record shall also be easily legible and non-

erasable.

A measuring instrument for direct sales trading transactions shall be designed to

present the measurement result to both parties in the transaction when installed

as intended. When critical in case of direct sales, any ticket provided to the

consumer by an ancillary device not complying with the appropriate

requirements of these regulations shall bear an appropriate restrictive

information.

Whether or not a measuring instrument intended for utility measurement

purposes can be remotely read it shall in any case be fitted with a metrologically

controlled display accessible without tools to the consumer. The reading of this

display is the measurement result that serves as the basis for the price to pay.

11. Further processing of data to conclude the trading transaction

A measuring instrument other than a utility measuring instrument shall record

by a durable means the measurement result accompanied by information to

identify the particular transaction, when

-

the measurement is non-repeatable and;

-

the measuring instrument is normally intended for use in the absence

of one of the trading parties.

Additionally, a durable proof of the measurement result and the information to

identify the transaction shall be available on request at the time the

measurement is concluded.

12. Conformity evaluation

A measuring instrument shall be designed so as to allow ready evaluation of its

conformity with the appropriate requirements of these regulations.

Schedule II

(Regulation 7)

DECLARATION OF CONFORMITY BASED ON INTERNAL PRODUCTION

CONTROL

(Conformity Assessment Module A)

1. The 'declaration of conformity based on internal production control' is the

conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in this Schedule and ensures and declares that the

measuring instruments concerned satisfy the appropriate requirements of these

regulations.

Technical documentation

2. The manufacturer shall establish the technical documentation as described in

regulation 9 of these regulations. The documentation shall enable assessment of

the conformity of the instrument with the appropriate requirements of these

regulations. It shall, as far as relevant for such assessment, cover the design,

manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the

national authorities for ten years after the last instrument has been

manufactured.

Manufacturing

4. The manufacturer shall take all measures necessary to ensure conformity of the

manufactured instruments with the appropriate requirements of these

regulations.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking and the supplementary metrology

marking to each measuring instrument that satisfies the appropriate

requirements of these regulations.

A declaration of conformity is drawn up for an instrument model and shall be

kept at the disposal of the national authorities for ten years after the last

instrument has been manufactured. It shall identify the instrument for which it

was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

Authorised representative

6. The manufacturer's obligations contained in paragraphs 3 and 5.2 may be

fulfilled, on his behalf and under his responsibility, by his authorised

representative.

Where the manufacturer is not established within the Community and where he

does not have an authorised representative, the obligations contained in

paragraphs 3 and 5.2 shall be the responsibility of the person who places the

instrument on the market.

Schedule IIa

(Regulation 7)

DECLARATION OF CONFORMITY BASED ON INTERNAL PRODUCTION

CONTROL PLUS PRODUCT TESTING BY A NOTIFIED BODY

(Conformity Assessment Module A1)

1. 'Declaration of conformity based on internal production control plus product

testing by a notified body' is the conformity assessment procedure whereby the

manufacturer fulfils the obligations laid down in this Schedule, and ensures and

declares that the measuring instruments concerned satisfy the appropriate

requirements of these regulations.

Technical documentation

2. The manufacturer shall establish the technical documentation as described in

regulation 9 of these regulations. The documentation shall enable assessment of

the conformity of the instrument with the appropriate requirements of these

regulations. It shall, as far as relevant for such assessment, cover the design,

manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the

national authorities for ten years after the last instrument has been

manufactured.

Manufacturing

4. The manufacturer shall take all measures necessary to ensure conformity of the

manufactured instruments with the appropriate requirements of these

regulations.

Product checks

5. A notified body, chosen by the manufacturer, shall carry out product checks or

have them carried out in appropriate intervals determined by it, in order to

verify the quality of the internal checks of the product, taking into account inter

alia the technological complexity of the instruments and the quantity of

production. An adequate sample of the final products, taken by the notified

body before the placing on the market, shall be examined and appropriate tests

as identified by the relevant document(s) referred to in regulation 13 of these

regulations, or equivalent tests, shall be carried out to check the conformity of

the instruments with the appropriate requirements of these regulations. In the

absence of a relevant document, the notified body concerned shall decide on the

appropriate tests to be carried out. In those cases where a relevant number of

instruments in the sample do not conform to an acceptable quality level, the

notified body shall take appropriate measures.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 5, the latter's identification number to each measuring instrument that

satisfies the appropriate requirements of these regulations.

A declaration of conformity is drawn up for an instrument model and shall be

kept at the disposal of the national authorities for ten years after the last

instrument has been manufactured. It shall identify the instrument for which it

was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

Authorised representative

6. The manufacturer's obligations contained in paragraphs 3 and 6.2 may be

fulfilled, on his behalf and under his responsibility, by his authorised

representative.

Where the manufacturer is not established within the Community and where he

does not have an authorised representative, the obligations contained in

paragraphs 3 and 6.2 shall be the responsibility of the person who places the

instrument on the market.

Schedule III

(Regulation 7)

TYPE EXAMINATION

(Conformity Assessment Module B)

1. 'Type examination' is the part of a conformity assessment procedure whereby a

notified body examines the technical design of a measuring instrument and

ensures and declares that the technical design meets the appropriate

requirements of these regulations.

2. Type examination may be carried out in either of the following manners. The

notified body decides on the appropriate manner and the specimens required

(a) examination of a specimen, representative of the production envisaged,

of the complete measuring instrument;

(b) examination of specimens, representative of the production envisaged,

of one or more critical parts of the measuring instrument, plus

assessment of the adequacy of the technical design of the other parts of

the measuring instrument through examination of the technical

documentation and supporting evidence referred to in paragraph 3;

(c) assessment of the adequacy of the technical design of the measuring

instrument through examination of the technical documentation and

supporting evidence referred to in paragraph 3, without examination of

a specimen.

3. The application for type examination shall be lodged by the manufacturer with a

notified body of his choice.

The application shall include

-

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address in

addition;

-

a written declaration that the same application has not been lodged

with any other notified body;

-

the technical documentation as described in regulation 9 of these

regulations. The documentation shall enable assessment of the

conformity of the instrument with the appropriate requirements of

these regulations. It shall, as far as relevant for such assessment, cover

the design, manufacture and operation of the instrument;

-

the specimens, representative of the production envisaged, as required

by the notified body;

-

the supporting evidence for the adequacy of the technical design of

those parts of the measuring instrument for which no specimens are

required. This supporting evidence shall mention any relevant

documents that have been applied, in particular where the relevant

documents referred to in regulation 13 of these regulations have not

been applied in full, and shall include, where necessary, the results of

tests carried out by the appropriate laboratory of the manufacturer, or

by another testing laboratory on his behalf and under his

responsibility.

4. The notified body shall

For the specimens

examine the technical documentation, verify that the specimens have been

manufactured in conformity with it and identify the elements which have been

designed in accordance with the relevant provisions of the relevant documents

referred to in regulation 13 of these regulations, as well as the elements which

have been designed without applying the relevant provisions of those

documents;

carry out the appropriate examinations and tests, or have them carried out, to

check whether, where the manufacturer has chosen to apply the solutions in the

relevant documents referred to in regulation 13 of these regulations, these have

been applied correctly;

carry out the appropriate examinations and tests, or have them carried out, to

check whether, where the manufacturer has chosen not to apply the solutions in

the relevant documents referred to in regulation 13 of these regulations, the

solutions adopted by the manufacturer meet the corresponding essential

requirements of these regulations;

agree with the applicant on the location where the examinations and tests shall

be carried out.

For the other parts of the measuring instrument

examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the other parts of the measuring instrument.

For the manufacturing process

examine the technical documentation to assure that the manufacturer has

adequate means to ensure consistent production.

The notified body shall draw up an evaluation report that records the activities

as undertaken in accordance with paragraph 4 and their outcomes. Without

prejudice to 12(1)(h), the notified body shall release the content of this report,

in full or in part, only with the agreement of the manufacturer.

Where the technical design meets the requirements of these regulations that

apply to the measuring instrument, the notified body shall issue an EC-type

examination certificate to the manufacturer. The certificate shall contain the

name and address of the manufacturer and, if appropriate, of his authorised

representative, conclusions of the examination, conditions (if any) for its

validity and the necessary data for identification of the instrument. The

certificate may have one or more annexes attached.

The certificate and its annexes shall contain all relevant information for

conformity evaluation and in-service control. In particular, to allow the

conformity of manufactured instruments to be evaluated with the examined type

regarding the reproducibility of their metrological performances, when they are

properly adjusted using appropriate means, content shall include

-

the metrological characteristics of the type of instrument;

-

measures required for ensuring the integrity of the instruments

(sealing, identification of software, etc.);

-

information on other elements necessary for the identification of the

instruments and to check their visual external conformity to type;

-

if appropriate, any specific information necessary to verify the

characteristics of manufactured instruments;

-

in the case of a sub-assembly, all necessary information to ensure the

compatibility with other sub-assemblies or measuring instruments.

The certificate shall have a validity of ten years from the date of its issue, and

may be renewed for subsequent periods of ten years each.

The notified body shall establish an evaluation report in this regard and keep it

at the disposal of the Member State that designated it.

6. The manufacturer shall inform the notified body that holds the technical

documentation concerning the EC-type examination certificate of all

modifications to the instrument that may affect the conformity of the instrument

with the essential requirements or the conditions for validity of the certificate.

Such modifications require additional approval in the form of an addition to the

original EC-type examination certificate.

7. Each notified body shall immediately inform the Member State that designated

it about

-

EC-type examination certificates and annexes issued;

-

additions and amendments relating to certificates already issued.

Each notified body shall immediately inform the Member State that designated

it of the withdrawal of an EC-type examination certificate.

The notified body shall hold the technical file including the documentation

submitted by the manufacturer for a period up to the end of the validity of the

certificate.

8. The manufacturer shall keep a copy of the EC-type examination certificate, its

annexes and additions with the technical documentation for 10 years after the

last measuring instrument has been manufactured.

9. The manufacturer's authorised representative may lodge the application referred

to in paragraph 3 and carry out the obligations mentioned in paragraphs 6 and 8.

Where the manufacturer is not established within the Communities and where

he does not have an authorised representative, the obligation to make the

technical documentation available on request shall be the responsibility of the

person designated by the manufacturer.

Schedule IV

(Regulation 7)

DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL

PRODUCTION CONTROL

(Conformity Assessment Module C)

1. 'Declaration of conformity to type based on internal production control' is the

part of a conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in this Schedule and ensures and declares that the

measuring instruments concerned are in conformity with the type as described

in the EC-type examination certificate and satisfy the appropriate requirements

of these regulations..

Manufacturing

2. The manufacturer shall take all measures necessary to ensure conformity of the

manufactured instruments with the type as described in the EC-type

examination certificate and with the appropriate requirements of these

Regulations.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking and the supplementary metrology

marking to each measuring instrument that is in conformity with the type as

described in the EC-type examination certificate and satisfies the appropriate

requirements of these regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

Authorised representative

4. The manufacturer's obligations contained in paragraph 3.2 may be fulfilled, on

his behalf and under his responsibility, by his authorised representative.

Where the manufacturer is not established within the Community and where he

does not have an authorised representative, the obligation mentioned in

paragraph 3.2 shall be the responsibility of the person who places the

instrument on the market.

Schedule IVa

(Regulation 7)

DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL

PRODUCTION CONTROL PLUS PRODUCT TESTING BY A NOTIFIED BODY

(Conformity Assessment Module C1)

1. 'Declaration of conformity to type based on internal production control plus

product testing by a notified body' is the part of a conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in this

Schedule and ensures and declares that the measuring instruments concerned

are in conformity with the type as described in the EC-type examination

certificate and satisfy the appropriate requirements of these regulations.

Manufacturing

2. The manufacturer shall take all measures necessary to ensure conformity of the

manufactured instruments with the type as described in the EC-type

examination certificate and with the appropriate requirements of these

Regulations.

Product checks

3. A notified body, chosen by the manufacturer, shall carry out product checks or

have them carried out in appropriate intervals determined by it, in order to

verify the quality of the internal checks of the product, taking into account inter

alia the technological complexity of the instruments and the quantity of

production. An adequate sample of the final products, taken by the notified

body before the placing on the market, shall be examined and appropriate tests,

as identified by the relevant documents referred to in regulation 13 of these

regulations, or equivalent

tests, shall be carried out to check the conformity of the product with the type as

described in the EC-type examination certificate and the appropriate

requirements of these Regulations. In the absence of a relevant document, the

notified body concerned shall decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not

conform to an acceptable quality level, the notified body shall take appropriate

measures.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 3, the latter's identification number, to each measuring instrument

that is in conformity with the type as described in the EC-type examination

certificate and satisfies the appropriate requirements of these regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

Authorised representative

5. The manufacturer's obligations contained in paragraph 4.2 may be fulfilled, on

his behalf and under his responsibility, by his authorised representative.

Where the manufacturer is not established within the Community and where he

does not have an authorised representative, the obligation mentioned in

paragraph 3.2 shall be the responsibility of the person who places the

instrument on the market.

Schedule V

(Regulation 7)

DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY

ASSURANCE OF THE PRODUCTION PROCESS

(Conformity Assessment Module D)

1. 'Declaration of conformity to type based on quality assurance of the production

process' is the part of a conformity assessment procedure whereby the

manufacturer fulfils the obligations laid down in this Schedule and ensures and

declares that the measuring instruments concerned are in conformity with the

type as described in the EC-type examination certificate and satisfy the

appropriate requirements of these regulations.

Manufacturing

2. The manufacturer shall operate an approved quality system for production, final

product inspection and testing of the measuring instrument concerned as

specified in paragraph 3 and shall be subject to surveillance as specified in

paragraph 4

Quality system

The manufacturer shall lodge an application for assessment of the quality

system with a notified body of his choice.

The application shall include

-

all relevant information for the instrument category envisaged;

-

the documentation concerning the quality system;

-

the technical documentation of the approved type and a copy of the EC-type

examination certificate.

The quality system shall ensure compliance of the instruments with the type as

described in the EC-type examination certificate and the appropriate

requirements of these Regulations.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of written

policies, procedures and instructions. This quality system documentation must

permit a consistent interpretation of the quality programmes, plans, manuals and

records.

It shall contain in particular an adequate description of

-

the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality;

-

the manufacturing, quality control and quality assurance techniques,

processes and systematic actions that will be used;

-

the examinations and tests that will be carried out before, during, and

after manufacture, and the frequency with which they will be carried

out;

-

the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc;

-

the means to monitor the achievement of the required product quality

and the effective operation of the quality system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in paragraph 3.2. It shall presume

conformity with these requirements in respect of a quality system that complies

with the corresponding specifications of the national standard that implements

the relevant harmonised standard, from the moment its references have been

published.

In addition to experience in quality management systems, the auditing team

shall possess appropriate experience in the relevant field of metrology and

instrument technology, and knowledge of the applicable requirements of these

regulations. The evaluation procedure shall include an inspection visit to the

manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

The manufacturer shall undertake to fulfill the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change of the quality system.

The notified body shall evaluate the modifications proposed and decide whether

the changed quality system will still satisfy the requirements referred to in

paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer fulfils the

obligations arising out of the approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes

to the locations of manufacture, inspection, testing and storage, and shall

provide it with all necessary information, in particular

-

the quality system documentation;

-

the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide an

audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out product tests,

or have them carried out, to verify that the quality system is functioning

correctly. It shall provide the manufacturer with a visit report and, if tests have

been carried out, with a test report.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 3.1, the latter's identification number, to each measuring instrument

that is in conformity with the type as described in the EC-type examination

certificate and satisfies the appropriate requirements of these regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments are delivered to a single user.

6. The manufacturer shall, for 10 years after the last instrument has been

manufactured, keep at the disposal of the national authorities

- the documentation referred to in paragraph 3.1, second indent;

- the change referred to in paragraph 3.5, as approved;

- the decisions and reports from the notified body referred to in

paragraphs 3.5, 4.3 and 4.4.

7. Each notified body shall periodically make available to the Member State that

designated it the list of quality system approvals issued or refused, and shall

immediately inform the Member State that designated it of the withdrawal of a

quality system approval.

Authorised representative

8. The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2, and 6 may

be fulfilled, on his behalf and under his responsibility, by his authorised

representative.

Schedule Va

(Regulation 7)

DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF

THE PRODUCTION PROCESS

(Conformity Assessment Module D1)

1. 'Declaration of conformity based on quality assurance of the production process'

is the conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in this Schedule and ensures and declares that the

measuring instruments concerned satisfy the appropriate requirements of these

regulations.

Technical documentation

2. The manufacturer shall establish the technical documentation as described in

regulation 10 of these regulations. The documentation shall enable assessment

of the conformity of the instrument with the appropriate requirements of these

Regulations. It shall, as far as relevant for such assessment, cover the design

and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the

national authorities for 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall operate an approved quality system for production, final

product inspection and testing of the measuring instrument concerned as

specified in paragraph 5 and shall be subject to surveillance as specified in

paragraph 6.

Quality system

The manufacturer shall lodge an application for assessment of the quality

system with a notified body of his choice.

The application shall include

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system;

the technical documentation referred to in paragraph 2.

The quality system shall ensure compliance of the instruments with the

appropriate requirements of these regulations.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of written

policies, procedures and instructions. This quality system documentation must

permit a consistent interpretation of the quality programmes, plans, manuals and

records.

It shall contain, in particular, an adequate description of

-

the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality;

-

the manufacturing, quality control and quality assurance techniques,

processes and systematic actions that will be used;

-

the examinations and tests that will be carried out before, during, and

after manufacture, and the frequency with which they will be carried

out;

-

the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.;

-

the means to monitor the achievement of the required product quality

and the effective operation of the quality system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in paragraph 5.2. It shall presume

conformity with these requirements in respect of a quality system that complies

with the corresponding specifications of the national standard that implements

the relevant harmonised standard, from the moment its references have been

published.

In addition to experience in quality management systems, the auditing team

shall possess appropriate experience in the relevant field of metrology and

instrument technology, and knowledge of the applicable requirements of these

regulations. The evaluation procedure shall include an inspection visit to the

manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

The manufacturer shall undertake to fulfill the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

The manufacturer shall keep the notified body that has approved the quality

system periodically informed of any intended change of the quality system.

The notified body shall evaluate the changes proposed and decide whether the

changed quality system will still satisfy the requirements referred to in

paragraph 5.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer fulfils the

obligations arising out of the approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes

to the locations of manufacture, inspection, testing and storage, and shall

provide it with all necessary information, in particular

-

the quality system documentation;

-

the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide an

audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out product tests,

or have them carried out, to verify that the quality system is functioning

correctly. It shall provide the manufacturer with a visit report and, if tests have

been carried out, with a test report.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 5.1, the latter's identification number, to each measuring instrument

that satisfies the appropriate requirements of these regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

8. The manufacturer shall, for 10 years after the last instrument has been

manufactured, keep at the disposal of the national authorities

- the documentation referred to in paragraph 5.1, second indent;

- the change referred to in paragraph 5.5, as approved;

- the decisions and reports from the notified body referred to in

paragraphs 5.5, 6.3 and 6.4.

9. Each notified body shall periodically make available to the Member State that

designated it the list of quality system approvals issued or refused, and shall

immediately inform the Member State that designated it of the withdrawal of a

quality system approval.

Authorised representative

10. The manufacturer's obligations contained in paragraphs 3, 5.1, 5.5, 7.2, and 8

may be fulfilled, on his behalf and under his responsibility, by his authorised

representative.

Schedule VI

(Regulation 7)

DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY

ASSURANCE OF FINAL PRODUCT INSPECTION AND TESTING

(Conformity Assessment Module E)

1. 'Declaration of conformity to type based on quality assurance of final product

inspection and testing' is the part of a conformity assessment procedure

whereby the manufacturer fulfils the obligations laid down in this Schedule and

ensures and declares that the measuring instruments concerned are in

conformity with the type as described in the EC-type examination certificate

and satisfy the appropriate requirements of these regulations.

Manufacturing

2. The manufacturer shall operate an approved quality system as specified in

paragraph 3 for final product inspection and testing of the measuring instrument

concerned and shall be subject to surveillance, as specified in paragraph 4.

Quality system

The manufacturer shall lodge an application for assessment of the quality

system with a notified body of his choice.

The application shall include

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system;

- the technical documentation of the approved type and a copy of the EC-type

examination certificate.

The quality system shall ensure compliance of the instruments with the type as

described in the EC-type examination certificate and the appropriate

requirements of these regulations.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of written

policies, procedures and instructions. This quality system documentation must

permit a consistent interpretation of the quality programmes, plans, manuals and

records.

It shall contain in particular an adequate description of

-

the quality objectives and the organisational structure, responsibilities

and powers of the management with

regard to product quality;

-

the examinations and tests that will be carried out after manufacture;

-

the quality records, such as inspection reports and test data, calibration

data, qualification reports of the

personnel concerned, etc.;

-

the means to monitor the effective operation of the quality system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in paragraph 3.2. It shall presume

conformity with these requirements in respect of a quality system that complies

with the corresponding specifications of the national standard that implements

the relevant harmonised standard, from the moment its references have been

published.

In addition to experience in quality management systems, the auditing team

shall possess appropriate experience in the relevant field of metrology and

instrument technology, and knowledge of the applicable requirements of these

regulations. The evaluation procedure shall include an inspection visit to the

manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

The manufacturer shall undertake to fulfill the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change of the quality system.

The notified body shall evaluate the modifications proposed and decide whether

the changed quality system will still satisfy the requirements referred to in

paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer fulfils the

obligations arising out of the approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes

to the locations of manufacture, inspection, testing and storage, and shall

provide it with all necessary information, in particular

-

the quality system documentation;

-

the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide an

audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out product tests,

or have them carried out, to verify that the quality system is functioning

correctly. It shall provide the manufacturer with a visit report and, if tests have

been carried out, with a test report.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 3.1, the latter's identification number, to each measuring instrument

that is in conformity with the type as described in the EC-type examination

certificate and satisfies the appropriate requirements of these regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

6. The manufacturer shall, for 10 years after the last instrument has been

manufactured, keep at the disposal of the national authorities

- the documentation referred to in paragraph 3.1, second indent;

- the change referred to in paragraph 3.5, as approved;

- the decisions and reports from the notified body referred to in paragraph

3.5, final sub-paragraph 4.3 and paragraph 4.4.

7. Each notified body shall periodically make available to the Member State that

designated it the list of quality system approvals issued or refused, and shall

immediately inform the Member State that designated it of the withdrawal of a

quality system approval.

Authorised representative

8. The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2, and 6 may

be fulfilled, on his behalf and under his responsibility, by his authorised

representative.

Schedule VIa

(Regulation 7)

DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF

FINAL PRODUCT INSPECTION AND TESTING

(Conformity Assessment Module E1)

1. 'Declaration of conformity to type based on quality assurance of final product

inspection and testing' is the part of a conformity assessment procedure

whereby the manufacturer fulfils the obligations laid down in this Schedule and

ensures and declares that the measuring instruments concerned are in

conformity with the appropriate requirements of these regulations.

Technical documentation

2. The manufacturer shall establish the technical documentation as described in

regulation 9 of these regulations. The documentation shall enable assessment of

the conformity of the instrument with the appropriate requirements of these

Regulations. It shall, as far as relevant for such assessment, cover the design,

manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the

national authorities for 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall operate an approved quality system for final product

inspection and testing of the measuring instrument concerned as specified in

paragraph 5 and shall be subject to surveillance as specified in paragraph 6.

Quality system

The manufacturer shall lodge an application for assessment of the quality

system with a notified body of his choice.

The application shall include

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system;

- the technical documentation referred in paragraph 2.

The quality system shall ensure compliance of the instruments with the

appropriate requirements of these Regulations.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of written

policies, procedures and instructions. This quality system documentation must

permit a consistent interpretation of the quality programmes, plans, manuals and

records.

This documentation shall contain in particular an adequate description of

-

the quality objectives and the organisational structure, responsibilities and

powers of the management with regard to product quality;

-

the examinations and tests that will be carried out after manufacture;

-

the quality records, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc;

-

the means to monitor the effective operation of the quality system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in paragraph 5.2. It shall presume

conformity with these requirements in respect of a quality system that complies

with the corresponding specifications of the national standard that implements

the relevant harmonised standard, from the moment its references have been

published.

In addition to experience in quality management systems, the auditing team

shall possess appropriate experience in the relevant field of metrology and

instrument technology, and knowledge of the applicable requirements of these

regulations. The evaluation procedure shall include an inspection visit to the

manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

The manufacturer shall undertake to fulfill the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change of the quality system.

The notified body shall evaluate the changes proposed and decide whether the

changed quality system will still satisfy the requirements referred to in

paragraph 5.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer fulfils the

obligations arising out of the approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes

to the locations of inspection, testing and storage, and shall provide it with all

necessary information, in particular

-

the quality system documentation;

-

the technical documentation referred to in paragraph 2;

-

the quality records, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide an

audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out product tests,

or have them carried out, to verify that the quality system is functioning

correctly. It shall provide the manufacturer with a visit report and, if tests have

been carried out, with a test report.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 5.1, the latter's identification number, to each measuring instrument

that satisfies the appropriate requirements of these regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

8. The manufacturer shall, for 10 years after the last instrument has been

manufactured, keep at the disposal of the national authorities

- the documentation referred to in paragraph 5.1, second indent;

- the change referred to in paragraph 5.5, as approved;

- the decisions and reports from the notified body referred to in

paragraphs 5.5, 6.3 and 6.4.

9. Each notified body shall periodically make available to the Member State that

designated it the list of quality system approvals issued or refused, and shall

immediately inform the Member State that designated it of the withdrawal of a

quality system approval.

Authorised representative

8. The manufacturer's obligations contained in paragraphs 3, 5.1, 5.5, 7.2, and 8

may be fulfilled, on his behalf and under his responsibility, by his authorised

representative.

Schedule VII

(Regulation 7)

DECLARATION OF CONFORMITY TO TYPE BASED ON PRODUCT

VERIFICATION

(Conformity Assessment Module F)

1. 'Declaration of conformity to type based on product verification' is the part of a

conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in this Schedule and ensures and declares that the

measuring instruments that have been subjected to the provisions of paragraph 3

are in conformity with the type as described in the EC-type examination

certificate and satisfy the appropriate requirements of these regulations.

Manufacturing

2. The manufacturer shall take all measures necessary to ensure conformity of the

manufactured instruments with the approved type as described in the EC-type

examination certificate and the appropriate requirements of these regulations.

Verification

3. A notified body chosen by the manufacturer shall carry out the appropriate

examinations and tests, or have them carried out, to check the conformity of the

instruments with the type as described in the EC-type examination certificate

and the appropriate requirements of these Regulations.

The examinations and tests to check the conformity with the metrological

requirements will be carried out, at the choice of the manufacturer, either by

examination and testing of every instrument as specified in paragraph 4, or by

examination and testing of the instruments on a statistical basis as specified in

paragraph 5.

4. Verification of conformity with the metrological requirements by examination

and testing of every instrument.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number to

each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the certification of the

instrument.

5. Statistical verification of conformity with the metrological requirements.

The manufacturer shall take all measures necessary in order that the

manufacturing process ensures the homogeneity of each lot produced, and shall

present his instruments for verification in the form of homogeneous lots.

A random sample shall be drawn from each lot according to the requirements of

paragraph 5.3. All instruments in the sample shall be individually examined

and appropriate tests as set out in the relevant documents referred to in

regulation 13 of these regulations, or equivalent tests, to establish their

conformity with the metrological requirements that apply to them shall be

carried out to determine whether the lot is accepted or rejected. In the absence

of a relevant document, the notified body concerned shall decide on the

appropriate tests to be carried out.

The statistical procedure shall meet the following requirements

The statistical control will be based on attributes. The sampling system shall

ensure

-

a level of quality corresponding to a probability of acceptance of 95 %, with

a non-conformity of less than 1 %;

-

a limit quality corresponding to a probability of acceptance of 5 %, with a

non-conformity of less than 7 %.

If a lot is accepted, all instruments of the lot are approved, except for those

instruments from the sample that were found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number to

each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the certification of the

instrument

. If a lot is rejected, the notified body shall take appropriate measures to prevent

the placing on the market of that lot. In the event of frequent rejection of lots

the notified body may suspend the statistical verification and take appropriate

measures

Written declaration of conformity

The manufacturer shall affix the 'CE' marking and the supplementary metrology

marking to each measuring instrument that is in conformity with the approved

type and satisfies the appropriate requirements of these Regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

If agreed upon by the notified body referred to in paragraph 3, the manufacturer

shall also affix the notified body's identification number to the measuring

instruments under the notified body's responsibility.

7. The manufacturer may, if agreed upon by the notified body and under its

responsibility, affix the notified body's identification number to the measuring

instruments during the manufacturing process.

Authorised representative

8. The manufacturer's obligations may be fulfilled, on his behalf and under his

responsibility, by his authorized representative except for the obligations

contained in paragraphs 2 and 5.1.

.

Schedule VIIa

(Regulation 7)

DECLARATION OF CONFORMITY BASED ON PRODUCT VERIFICATION

(Conformity Assessment Module F1)

'Declaration of conformity based on product verification' is the conformity

1. assessment procedure whereby the manufacturer fulfils the obligations laid

down in this Schedule and ensures and declares that the measuring instruments

that have been subjected to the provisions of paragraph 5 are in conformity with

the appropriate requirements of these regulations.

Technical Documentation

The manufacturer shall establish the technical documentation as described in

2. regulation 9 of these regulations. The documentation shall enable assessment of

the conformity of the instrument with the appropriate requirements of these

regulations. It shall, as far as relevant for such assessment, cover the design,

manufacture and operation of the instrument.

.

3. The manufacturer shall keep the technical documentation at the disposal of the

national authorities for 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall take all measures necessary to ensure conformity of the

manufactured instruments with the appropriate requirements of these

regulations.

Verification

5. A notified body chosen by the manufacturer shall carry out the appropriate

examinations and tests, or have them carried out, to check the conformity of the

instruments with the appropriate requirements of these regulations.

The examinations and tests to check the conformity with the metrological

requirements will be carried out, at the choice of the manufacturer, either by

examination and testing of every instrument as specified in paragraph 6, or by

examination and testing of the instruments on a statistical basis as specified in

paragraph 7.

6. Verification of conformity with the metrological requirements by examination

and testing of every instrument.

All instruments shall be individually examined and appropriate tests as set out

in the relevant documents referred to in regulation 13 of these regulations, or

equivalent tests, shall be carried out to verify their conformity with the

metrological requirements that apply to them. In the absence of a relevant

document, the notified body concerned shall decide on the appropriate tests to

be carried out.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number to

each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the certification of the

instrument.

7. Statistical verification of conformity with the metrological requirements.

The manufacturer shall take all measures necessary in order that the

manufacturing process ensures the homogeneity of each lot produced, and shall

present his instruments for verification in the form of homogeneous lots.

A random sample shall be drawn from each lot according to the requirements of

paragraph 7.3. All instruments in the sample shall be individually examined

and appropriate tests as set out in the relevant documents referred to in

regulation 13 of these regulations, or equivalent tests, to establish their

conformity with the metrological requirements that apply to them shall be

carried out to determine whether the lot is accepted or rejected. In the absence

of a relevant document, the notified body concerned shall decide on the

appropriate tests to be carried out.

The statistical procedure shall meet the following requirements

The statistical control will be based on attributes. The sampling system shall

ensure

-

a level of quality corresponding to a probability of acceptance of 95 %, with

a non-conformity of less than 1 %;

-

a limit quality corresponding to a probability of acceptance of 5 %, with a

non-conformity of less than 7 %.

If a lot is accepted, all instruments of the lot are approved, except for those

instruments from the sample that were found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number to

each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the certification of the

instrument

If a lot is rejected, the notified body shall take appropriate measures to prevent

the placing on the market of that lot. In the event of frequent rejection of lots

the notified body may suspend the statistical verification and take appropriate

measures

Written declaration of conformity

The manufacturer shall affix the 'CE' marking and the supplementary metrology

marking to each measuring instrument that is in conformity with the approved

type and satisfies the appropriate requirements of these Regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

If agreed upon by the notified body referred to in paragraph 5, the manufacturer

shall also affix the notified body's identification number to the measuring

instruments under the notified body's responsibility.

9. The manufacturer may, if agreed upon by the notified body and under its

responsibility, affix the notified body's identification number to the measuring

instruments during the manufacturing process.

Authorised representative

10. The manufacturer's obligations may be fulfilled, on his behalf and under his

responsibility, by his authorized representative except for the obligations

contained in paragraphs 4 and 7.1.

.

Schedule VIII

(Regulation 7)

DECLARATION OF CONFORMITY BASED ON UNIT VERIFICATION

(Conformity Assessment Module G)

1. 'Declaration of conformity based on unit verification' is the conformity

assessment procedure whereby the manufacturer fulfils the obligations laid

down in this Schedule and ensures and declares that a measuring instrument that

has been subjected to the provisions of paragraph 4, is in conformity with the

appropriate requirements of these regulations.

Technical Documentation

The manufacturer shall establish the technical documentation as described in

2. regulation 9 of these regulations and make it available to the notified body

referred to in paragraph 4. The technical documentation shall enable

assessment of the conformity of the instrument with the appropriate

requirements of these regulations and shall, as far as relevant for such

assessment, cover the design, manufacture and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of the

national authorities for ten years.

Manufacturing

3. The manufacturer shall take all measures necessary to ensure conformity of the

manufactured instruments with the appropriate requirements of these

regulations.

Verification

4. A notified body chosen by the manufacturer shall carry out the appropriate

examinations and tests as set out in the relevant documents referred to in

regulation 13 of these regulations, or equivalent tests, to check the conformity

of the instrument with the appropriate requirements of these regulations, or have

them carried out. In the absence of a relevant document, the notified body

concerned shall decide on the appropriate tests to be carried out.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out and affix its identification number to the

approved instrument, or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the certification of the

instrument.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 4, the latter's identification number to each measuring instrument that

satisfies the appropriate requirements of these regulations.

A declaration of conformity shall be drawn up and kept at the disposal of the

national authorities for 10 years after the instrument has been manufactured. It

shall identify the instrument for which it was drawn up.

A copy of the declaration shall be supplied with the measuring instrument.

Authorised representative

6. The manufacturer's obligations contained in paragraphs 2 and 4.2 may be

fulfilled, on his behalf and under his responsibility, by his authorised

representative. .

Schedule IX

(Regulation 7)

DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE

(Conformity Assessment Module H)

1. 'Declaration of conformity based on full quality assurance' is the conformity

assessment procedure whereby the manufacturer fulfils the obligations laid

down in this Schedule and ensures and declares that the measuring

instruments concerned satisfy the appropriate requirements of these regulations.

Manufacturing

2. The manufacturer shall operate an approved quality system for design,

manufacture and final product inspection and testing of the measuring

instrument concerned as specified in paragraph 3, and shall be subject to

surveillance as specified in paragraph 4.

Quality System

The manufacturer shall lodge an application for assessment of the quality

system with a notified body of his choice.

The application shall include

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system.

The quality system shall ensure compliance of the instruments with the

appropriate requirements of these regulations.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of written

policies, procedures and instructions. This quality system documentation must

permit a consistent interpretation of the quality programmes, plans, manuals and

records. It shall contain in particular an adequate description of

- the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to design and product

quality;

- the technical design specifications, including standards, that will be

applied and, where the relevant documents referred to in regulation 13

of these regulations will not be applied in full, the means that will be

used to ensure that the essential requirements of these Regulations that

apply to the instruments will be met;

- the design control and design verification techniques, processes and

systematic actions that will be used when designing the instruments

pertaining to the instrument category covered;

- the corresponding manufacturing, quality control and quality assurance

techniques, processes and systematic actions that will be used;

- the examinations and tests that will be carried out before, during and

after manufacture, and their frequency;

- the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.;

- the means to monitor the achievement of the required design and

product quality and the effective operation of the quality system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in paragraph 3.2. It shall presume

conformity with these requirements in respect of a quality system that complies

with the corresponding specifications of the national standard that implements

the relevant harmonised standard, from the moment its references have been

published.

In addition to experience in quality management systems, the auditing team

shall possess appropriate experience in the relevant field of metrology and

instrument technology, and knowledge of the applicable requirements of these

regulations. The evaluation procedure shall include an inspection visit to the

manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

The manufacturer shall undertake to fulfil the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change of the quality system.

The notified body shall evaluate the changes proposed and decide whether the

changed quality system will still satisfy the requirements referred to in

paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer fulfils the

obligations arising out of the approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes

to the locations of manufacture, inspection, testing and storage, and shall

provide it with all necessary information, in particular

-

the quality system documentation;

-

the quality records as foreseen by the design part of the quality system,

such as results of analyses, calculations, tests, etc.;

-

the quality records as foreseen by the manufacturing part of the quality

system, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide an

audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out product tests,

or have them carried out under its responsibility, to verify that the quality

system is functioning correctly. It shall provide the manufacturer with a visit

report and, if tests have been carried out, with a test report.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 3.1, the latter's identification number to each measuring instrument

that satisfies the appropriate requirements of these regulations.

A declaration of conformity is drawn up for an instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the instrument model for

which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

6. The manufacturer shall, for 10 years after the last instrument has been

manufactured, keep at the disposal of the national authorities

- the documentation concerning the quality system referred to in

paragraph 3.1, second indent;

- the change referred to in paragraph 3.5, as approved;

- the decisions and reports from the notified body referred to in

paragraphs 3.5, 4.3 and 4.4.

7. Each notified body shall periodically make available to the Member State that

designated it the list of quality system approvals issued or refused, and shall

immediately inform the Member State that designated it of the withdrawal of a

quality system approval.

Authorised representative

8. The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may

be fulfilled, on his behalf and under his responsibility, by his authorised

representative.

Schedule IXa

(Regulation 7)

DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE

PLUS DESIGN EXAMINATION

(Conformity Assessment Module H1)

1. 'Declaration of conformity based on full quality assurance plus design

examination' is the conformity assessment procedure whereby the manufacturer

fulfils the obligations laid down in this Schedule and ensures and declares that

the measuring instruments concerned satisfy the appropriate requirements of

these regulations.

Manufacturing

2. The manufacturer shall operate an approved quality system for design,

manufacture and final product inspection and testing of the measuring

instrument concerned as specified in paragraph 3, and shall be subject to

surveillance as specified in paragraph 5. The adequacy of the technical design

of the measuring instrument shall have been examined according to the

provisions of paragraph 4.

Quality System

The manufacturer shall lodge an application for assessment of the quality

system with a notified body of his choice.

The application shall include

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system.

The quality system shall ensure compliance of the instruments with the

appropriate requirements of these regulations.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of written

policies, procedures and instructions. This quality system documentation must

permit a consistent interpretation of the quality programmes, plans, manuals and

records. It shall contain in particular an adequate description of

- the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to design and product

quality;

- the technical design specifications, including standards, that will be

applied and, where the relevant documents referred to in regulation 13

of these regulations will not be applied in full, the means that will be

used to ensure that the essential requirements of these Regulations that

apply to the instruments will be met;

- the design control and design verification techniques, processes and

systematic actions that will be used when designing the instruments

pertaining to the instrument category covered;

- the corresponding manufacturing, quality control and quality assurance

techniques, processes and systematic actions that will be used;

- the examinations and tests that will be carried out before, during and

after manufacture, and the frequency with which they will be carried

out;

- the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.;

- the means to monitor the achievement of the required design and

product quality and the effective operation of the quality system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in paragraph 3.2. It shall presume

conformity with these requirements in respect of a quality system that complies

with the corresponding specifications of the national standard that implements

the relevant harmonised standard, from the moment its references have been

published in the Official Journal.

In addition to experience in quality management systems, the auditing team

shall possess appropriate experience in the relevant field of metrology and

instrument technology, and knowledge of the applicable requirements of these

regulations. The evaluation procedure shall include an inspection visit to the

manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

The manufacturer shall undertake to fulfil the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change of the quality system.

The notified body shall evaluate the changes proposed and decide whether the

changed quality system will still satisfy the requirements referred to in

paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

Each notified body shall periodically make available to the Member State that

designated it the list of quality system approvals issued or refused, and shall

immediately inform the Member State that designated it of the withdrawal of a

quality system approval.

Design examination

The manufacturer shall lodge an application for examination of the design with

the notified body referred to in paragraph 3.1.

The application shall enable understanding of the design, manufacture and

operation of the instrument, and shall enable assessment of conformity with the

appropriate requirements of these regulations. It shall include

the name and address of the manufacturer;

a written declaration that the same application has not been lodged with

any other notified body;

the technical documentation as described in regulation 9 of these

regulations.

The documentation shall enable assessment of the

conformity of the instrument with the appropriate requirements of these

regulations. It shall, as far as relevant for such assessment, cover the

design and operation of the instrument;

the supporting evidence for the adequacy of the technical design. This

evidence shall mention any documents that have been applied, in

particular where the relevant documents referred to in regulation 13 of

these regulations have not been applied in full, and shall include, where

necessary, the results of tests carried out by the appropriate laboratory of

the manufacturer, or by another testing laboratory on his behalf and

under his responsibility.

The notified body shall examine the application, and where the design meets the

provisions of these regulations that apply to the measuring instrument it shall

issue an EC design examination certificate to the manufacturer. The certificate

shall contain the name and address of the manufacturer, the conclusions of the

examination, any conditions for its validity and the necessary data for

identification of the approved instrument.

All relevant parts of the technical documentation shall be annexed to the

certificate.

The certificate or its annexes shall contain all relevant information for

conformity evaluation and in-service control. It shall to allow the evaluation of

conformity of the manufactured instruments with the examined design

regarding the reproducibility of their metrological performances, when they are

properly adjusted using appropriate means, including

-

the metrological characteristics of the design of the instrument;

-

measures required for ensuring the integrity of the instruments (sealing,

identification of software ...);

-

information on other elements necessary for the identification of the

instrument and to check its visual external conformity to the design;

-

if appropriate, any specific information necessary to verify the

characteristics of manufactured instruments;

-

in the case of a sub-assembly, all necessary information to ensure the

compatibility with other sub-assemblies or measuring instruments.

The notified body shall establish an evaluation report in this regard and keep it

at the disposal of the Member State that designated it. Without prejudice to

regulation 12(1)(h) of these regulations, the notified body shall release the

content of this report, in full or in part, only with the agreement of the

manufacturer.

The certificate shall have a validity of ten years from the date of its issue, and

may be renewed for subsequent periods of ten years each.

If the manufacturer is denied a design examination certificate, the notified body

shall provide detailed reasons for the denial.

The manufacturer shall keep the notified body that has issued the 'EC design

examination certificate informed of any fundamental modification to the

approved design. Modifications to the approved design must receive additional

approval from the notified body that issued the 'EC design examination

certificate where such changes may affect the conformity with the essential

requirements of these regulations, the conditions for validity of the certificate or

the prescribed conditions for use of the instrument. This additional approval is

given in the form of an addition to the original 'EC design examination

certificate.

Each notified body shall periodically make available to the Member State that

designated it

-

'EC design examination certificates and annexes issued;

-

additions and amendments relating to certificates issued.

Each notified body shall immediately inform the Member State that designated

it of the withdrawal of an EC design examination certificate.

The manufacturer or his authorised representative shall keep a copy of the 'EC

design examination certificate, its annexes and additions with the technical

documentation for 10 years after the last measuring instrument has been

manufactured.

Where neither the manufacturer nor his authorised representative is established

within the Community, the obligation to make the technical documentation

available on request shall be the responsibility of the person designated by the

manufacturer.

Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer fulfils the

obligations arising out of the approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes

to the locations of design, manufacture, inspection, testing and storage, and

shall provide it with all necessary information, in particular

-

the quality system documentation;

-

the quality records as foreseen by the design part of the quality system,

such as results of analyses, calculations, tests, etc;

-

the quality records as foreseen by the manufacturing part of the quality

system, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide an

audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out product tests,

or have them carried out under its responsibility, to verify that the quality

system is functioning correctly. It shall provide the manufacturer with a visit

report and, if tests have been carried out, with a test report.

Written declaration of conformity

The manufacturer shall affix the 'CE' marking, the supplementary metrology

marking and, under the responsibility of the notified body referred to in

paragraph 3.1, the latter's identification number to each measuring instrument

that satisfies the appropriate requirements of these regulations.

A declaration of conformity is drawn up for each instrument model and shall be

kept at the disposal of the national authorities for 10 years after the last

instrument has been manufactured. It shall identify the model of the instrument

for which it was drawn up and shall mention the number of the design

examination certificate.

A copy of the declaration shall be supplied with each measuring instrument that

is placed on the market. However, this requirement may be interpreted as

applying to a batch or consignment rather than individual instruments in those

cases where a large number of instruments is delivered to a single user.

7. The manufacturer shall, for 10 years after the last instrument has been

manufactured, keep at the disposal of the national authorities

- the documentation concerning the quality system referred to in

paragraph 3.1, second indent;

- the change referred to in paragraph 3.5, as approved;

- the decisions and reports from the notified body referred to in

paragraphs 3.5, 5.3 and 5.4.

Authorised representative

8. The manufacturer's obligations contained in paragraphs 3.1, 3.5, 6.2 and 7 may

be fulfilled, on his behalf and under his responsibility, by his authorised

representative.

Schedule X

(Regulations 4 and 5)

WATER METERS

The relevant requirements of Schedule I, the specific requirements of this Schedule and the

conformity assessment procedures listed in this Schedule, apply to water meters intended for

the measurement of volumes of clean, cold or heated water in residential, commercial and

light industrial use.

DEFINITIONS

Water Meter

An instrument designed to measure, memorise and display the volume at metering conditions

of water passing through the measurement transducer.

Minimum Flowrate (Q 1 )

The lowest flowrate at which the water meter provides indications that satisfy the

requirements concerning the maximum permissible errors (MPEs.)

Transitional Flowrate (Q 2 )

The transitional flowrate is the flowrate value occurring between the permanent and

minimum flowrates, at which the flowrate range is divided into two zones, the 'upper zone'

and the lower zone'. Each zone has a characteristic MPE.

Permanent Flowrate (Q 3 )

The highest flowrate at which the water meter operates in a satisfactory manner under normal

conditions of use, i.e. under steady or intermittent flow conditions.

Overload Flowrate (Q 4 )

The overload flowrate is the highest flowrate at which the meter operates in a satisfactory

manner for a short period of time without deteriorating.

SPECIFIC REQUIREMENTS

Rated Operating Conditions

The manufacturer shall specify the rated operating conditions for the instrument, in

1. The flowrate range of the water.

The values for the flowrate range shall fulfil the following conditions

Q 3 /Q 1 ≥ 10

Q 2 /Q1 = 1.6

Q 4 /Q 3 = 1.25

For 5 years from the date of entry into force of these regulations the ratio Q 2 /Q 1

may be: 1.5, 2.5, 4 or 6.3.

2. The temperature range of the water.

The values for the temperature range shall fulfil the following conditions

0.1 °C to at least 30 °C, or

30 °C to at least 90 °C.

3. The relative pressure range of the water, the range being 0.3 bar to at least 10

bar at Q 3 .

4. For the power supply: the nominal value of the AC voltage supply and/or the

limits of DC supply

5. The MPE, positive or negative, on volumes delivered at flowrates between the

transitional flowrate (Q 2 ) (included) and the overload flowrate (Q 4 ) is

2% for water having a temperature ≤ 30 °C,

3% for water having a temperature > 30 °C.

The MPE, positive or negative, on volumes delivered at flowrates between the

minimum flowrate (Q 1 ) and the transitional flowrate (Q 2 ) (excluded) is 5 % for

water having any temperature

Permissible Effect of Disturbances

Electromagnetic immunity

The effect of an electromagnetic disturbance on a water meter shall be such

that

- the change in the measurement result is no greater than the critical

change value as defined in 7.1.3, or

- the indication of the measurement result is such that it cannot be

interpreted as a valid result, such as a momentary variation that cannot

be interpreted, memorised or transmitted as a measuring result.

After undergoing an electromagnetic disturbance the water meter shall

- recover to operate within MPE, and

- have all measurement functions safeguarded, and

- allow recovery of all measurement data present just before the

disturbance.

The critical change value is the smaller of the two following values

- the volume corresponding to half of the magnitude of the MPE in the

upper zone on the measured volume;

the volume corresponding to the MPE on the volume corresponding to one

minute at flowrate Q 3 .

Durability

After an appropriate test, taking into account the period of time estimated by the

manufacturer, has been performed, the following criteria shall be satisfied

The variation of the measurement result after the durability test, when compared

with the initial measurement result, shall not exceed

- 3 % of the metered volume between Q 1 included and Q 2 excluded;

- 1,5 % of the metered volume between Q 2 included and Q 4 included.

The error of indication for the volume metered after the durability test shall not

exceed

- ± 6 % of the metered volume between Q 1 included and Q 2 excluded;

-

± 2,5 % of the metered volume between Q 2 included and Q 4 included for

water meters intended to meter water with a temperature between 0,1 °C

and 30 °C,

-

± 3,5 % of the metered volume between Q 2 included and Q 4 included for

water meters intended to meter water with a temperature between 30 °C

and 90 °C.

The meter shall be able to be installed to operate in any position unless clearly

marked otherwise.

The manufacturer shall specify whether the meter is designed to measure

reverse flow. In such a case, the reverse flow volume shall either be subtracted

from the cumulated volume or shall be separately recorded. The same MPE

shall apply to both forward and reverse flow.

Water meters not designed to measure reverse flow shall either prevent reverse

flow or shall withstand an accidental reverse flow without any deterioration or

change in metrological properties.

Units of Measurement

9. Metered volume shall be displayed in cubic metres.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these regulations that the

manufacturer can choose between are

B + F or B + D or H1

Schedule XI

(Regulations 4 and 5)

GAS METERS AND VOLUME CONVERSION DEVICES

The relevant requirements of Schedule I, the specific requirements of this Schedule and the

conformity assessment procedures listed in this Schedule, apply to gas meters and volume

conversion devices defined below, intended for residential, commercial and light industrial

use.

DEFINITIONS

Gas meter

An instrument designed to measure, memorise and display the quantity of fuel gas (volume

or mass) that has passed it.

Conversion device

A device fitted to a gas meter that automatically converts the quantity measured at metering

conditions into a quantity at base conditions.

Minimum flowrate (Q min )

The lowest flowrate at which the gas meter provides indications that satisfy the requirements

regarding maximum permissible error (MPE.)

Maximum flowrate (Q max )

The highest flowrate at which the gas meter provides indications that satisfy the requirements

regarding MPE.

Transitional flowrate (Q t )

The transitional flowrate is the flowrate occurring between the maximum and minimum

flowrates at which the flowrate range is divided into two zones, the 'upper zone' and the

'lower zone'. Each zone has a characteristic MPE.

Overload Flowrate (Q r )

The overload flowrate is the highest flowrate at which the meter operates for a short period

of time without deteriorating.

Base conditions

The specified conditions to which the measured quantity of fluid is converted.

PART I — SPECIFIC REQUIREMENTS — GAS METERS

1. Rated Operating Conditions

The manufacturer shall specify the rated operating conditions of the gas meter,

taking into account

1.1.

The flowrate range of the gas shall fulfil at least the following conditions

Class

Q max /Q min

Q max /Q t

Q r /Q max

≥150

≥10

1.5

1.2

≥20

≥5

1.0

1.2

1.2.

The temperature range of the gas, with a minimum range of 40 °C

1.3.

The gas meter shall be designed for the range of gases and supply pressures of

the country of destination. In particular the manufacturer shall indicate

- the gas family or group;

- the maximum operating pressure.

A minimum temperature range of 50 °C for the climatic environment.

The nominal value of the AC voltage supply and/or the limits of DC supply.

2. Maximum permissible error (MPEs)

.

Gas meter indicating the volume at metering conditions or mass

Table 1

Class

1.5

1.0

Q min ≤ Q < Q t

3%

2%

Q t ≤ Q ≤ Q max

1.5 %

1%

When the errors between Q t and Q max all have the same sign, they shall all not

exceed 1 % for class 1.5 and 0.5 % for Class 1.0.

For a gas meter with temperature conversion, which only indicates the

converted volume, the MPE of the meter is increased by 0.5 % in a range of

30°C extending symmetrically around the temperature specified by the

manufacturer that lies between 15 °C and 25 °C. Outside this range, an

additional increase of 0.5 % is permitted in each interval of 10 °C.

3. Permissible effect of disturbances

Electromagnetic immunity

The effect of an electromagnetic disturbance on a gas meter or volume

conversion device shall be such that

- the change in the measurement result is no greater than the critical

change value as defined in 3.1.3, or

- the indication of the measurement result is such that it cannot be

interpreted as a valid result, such as a momentary variation that cannot

be interpreted, memorised or transmitted as a measuring result.

After undergoing a disturbance, the gas meter shall

- recover to operate within MPE, and

- have all measurement functions safeguarded, and

- allow recovery of all measurement data present just before the

disturbance.

The critical change value is the smaller of the two following values

- the quantity corresponding to half of the magnitude of the MPE in the

upper zone on the measured volume;

- the quantity corresponding to the MPE on the quantity corresponding to

one minute at maximum flowrate.

Effect of upstream-downstream flow disturbances

Under installation conditions specified by the manufacturer, the effect of the

flow disturbances shall not exceed one third of the MPE.

4. Durability

After an appropriate test, taking into account the period of time estimated by the

manufacturer, has been performed, the following criteria shall be satisfied

Class 1.5 meters

The variation of the measurement result after the durability test when compared

with the initial measurement result for the flow rates in the range Q t to Q max

shall not exceed the measurement result by more than 2 %.

The error of indication after the durability test shall not exceed twice the MPE

in paragraph 2

Class 1.0 meters

The variation of the measurement result after the durability test when compared

with the initial measurement result shall not exceed one-third of the MPE in

paragraph 2.

The error of indication after the durability test shall not exceed the MPE in

paragraph 2

5. Suitability

A gas meter powered from the mains (AC or DC) shall be provided with an

emergency power supply device or other means to ensure, during a failure of

the principal power source, that all measuring functions are safeguarded.

A dedicated power source shall have a lifetime of at least five years. After 90 %

of its lifetime an appropriate warning shall be shown.

An indicating device shall have a sufficient number of digits to ensure that the

quantity passed during 8 000 hours at Q max does not return the digits to their

initial values.

The gas meter shall be able to be installed to operate in any position declared by

the manufacturer in its installation instruction.

The gas meter shall have a test element, which shall enable tests to be carried

out in a reasonable time.

The gas meter shall respect the MPE in any flow direction or only in one flow

direction clearly marked.

6. Units

Metered quantity shall be displayed in cubic meter, or in kilogram.

PART II — SPECIFIC REQUIREMENTS — VOLUME CONVERSION DEVICES

A volume conversion device constitutes a sub-assembly according to regulation 5 of these

regulations.

For a volume conversion device, the essential requirements for the gas meter shall apply, if

applicable. In addition, the following requirements shall apply

7. Base conditions for converted quantities.

The manufacturer shall specify the base conditions for converted quantities.

8. MPE

-

supply;

-

0.7 % for temperature conversion devices at rated operating conditions;

-

1 % for other conversion devices at rated operating conditions.

Note: The error of the gas meter is not taken into account.

9. Suitability

An electronic conversion device shall be capable of detecting when it is

operating outside the operating range(s) stated by the manufacturer for

parameters that are relevant for measurement accuracy. In such a case, the

conversion device must stop integrating the converted quantity, and may

totalise separately the converted quantity for the time it is operating outside the

operating range(s).

An electronic conversion device shall be capable to display all relevant data for

the measurement without additional equipment

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these

regulations that the manufacturer can choose between are

B + F oder B + D or H1.

Schedule XII

(Regulations 4 and 5)

ACTIVE ELECTRICAL ENERGY METERS

The relevant requirements of Schedule I, the specific requirements of this Schedule and the

conformity assessment procedures listed in this Schedule, apply to active electrical energy

meters intended for residential, commercial and light industrial use.

Note: Electrical energy meters may be used in combination with external instrument

transformers, depending upon the measurement technique applied. However, this Schedule

covers only electrical energy meters but not instrument transformers

DEFINITIONS

An active electrical energy meter is a device which measures the active electrical energy

consumed in a circuit.

I

= the electrical current flowing through the meter;

I n

= the specified reference current for which the transformer operated meter has

been designed;

I st

= the lowest declared value of I at which the meter registers active electrical

energy at unity power factor (polyphase meters with balanced load);

I min

= the value of I above which the error lies within maximum permissible errors

(MPEs) (polyphase meters with balanced load);

I tr

= the value of I above which the error lies within the smallest MPE’s

corresponding to the class index of the meter;

= the maximum value of I for which the error lies within the MPEs;

= the voltage of the electricity supplied to the meter;

= the specified reference voltage;

= the frequency of the voltage supplied to the meter;

= the specified reference frequency;

power factor = cosφ = the cosine of the phase difference φ between I and U.

SPECIFIC REQUIREMENTS

Accuracy

The manufacturer shall specify the class index of the meter. The class indices

are defined as: Class A, B and C.

Rated operating conditions

The manufacturer shall specify the rated operating conditions of the meter; in

particular

The values of f n , U n , I n , I st , I min , I tr and I max that apply to the meter. For the

current values specified, the meter shall satisfy the conditions given in Table 1;

Table 1

Class A

Class B

Class C

For direct-connected meters

≤ 0.05 I tr

≤ 0.04 I tr ≤ 0.04 I tr

I st

≤ 0.5 I tr

≤ 0.5 I tr

≤ 0.3 I tr

I min

≤ 50 I tr

≤ 50 I tr

≤ 50 I tr

I max

For transformer-operated meters

≤ 0.06 I tr

≤ 0.04 I tr ≤0.02 I tr

I st

≤0.2 I tr(1)

≤ 0.4 I tr

≤ 0.2 I tr

I min

= 20 I tr

= 20 I tr = 20 I tr

I n

≥ 1.2 I n

≥ 1.2 I n

≥ 1.2 I n

I max

( ) For Class B electromechanical meters I min ≤ 0.4 I tr shall apply.

The voltage, frequency and power factor ranges within which the meter shall

satisfy the MPE requirements are specified in Table 2. These ranges shall

recognise the typical characteristics of electricity supplied by public distribution

systems.

The voltage and frequency ranges shall be at least

0.9 U n ≤ U ≤ 1.1 U n

0.98 f n ≤ f ≤ 1.02·f n

power factor range at least from cosφ = 0.5 inductive to cosφ = 0.8 capacitive.

3. MPE’s

The effects of the various measurands and influence quantities (a, b, c, ..) are

evaluated separately, all other measurands and influence quantities being kept

relatively constant at their reference values. The error of measurement, that

shall not exceed the MPE stated in Table 2, is calculated as

a 2 + b 2 + c 2 ...

Error of measurement =

When the meter is operating under varying-load current, the percentage errors

shall not exceed the limits given in Table 2.

Table 2

MPEs in percent at rated operating conditions and defined load current

levels and operating temperature

Operating

Operating

Operating

Operating

temperatures

temperatures

temperatures

temperatures

+ 5°C…...+ 30 °C -10°C...+ 5 °C

-25°C…-10°C

-40°...-25°C

or

or

or

+30°C…...+ 40°C + 40°C... +55°C

+ 55 °C…+ 70 °C

Meter class

A

B

C

A

B

C

A

B

C

A

B

C

Single phase meter; polyphase meter if operating with balanced loads

I min ≤ I ≤ I tr

3.5

2.5

1.3

3.5

1.7

I tr ≤ I ≤ I max

3.5

0.7

4.5

2.5

3.5

1.3

1.5

Polyphase meter if operating with single phase load

I tr ≤ I ≤ I max

2.5

1.3

1.7

4.5

For electromechanical polyphase meters the current range for a single-phase load is limited to

5I tr ≤ I ≤ I max

When a meter operates in different temperature ranges the relevant MPE values

shall apply.

4. Permissible effect of disturbances

General

As electrical energy meters are directly connected to the mains supply and as

mains current is also one of the measurands, a special electromagnetic

environment is used for electricity meters.

The meter shall comply with the electromagnetic environment E2 and the

additional requirements in 4.2 and 4.3.

The electromagnetic environment and permissible effects reflect the situation

that there are disturbances of long duration which shall not affect the accuracy

beyond the critical change values and transient disturbances, which may cause a

temporary degradation or loss of function or performance but from which the

meter shall recover and shall not affect the accuracy beyond the critical change

values.

When there is a foreseeable high risk due to lightning or where overhead supply

networks are predominant, the metrological characteristics of the meter shall be

protected.

Effect of disturbances of long duration

Table 3

Critical change values for disturbances of long duration

Disturbance

Critical change values in percent for

meters of class

A

B

C

Reversed phase sequence

1.5

1.5

0.3

Voltage unbalance (only applicable to polyphase

meters)

Harmonic contents in the current circuits (1)

0.8

0.5

(1)

DC and harmonics in the current circuit

1.5

Fast transient bursts

Magnetic fields; HF (radiated RF) electromagnetic

field; Conducted disturbances introduced by radio-

frequency fields; and Oscillatory waves immunity

(1)

In the case of electromechanical electricity meters, no critical change values are defined

for harmonic contents in the current circuits and for DC and harmonics in the current

circuit.

Permissible effect of transient electromagnetic phenomena

The effect of an electromagnetic disturbance on an electrical energy meter shall

be such that during and immediately after a disturbance

- any output intended for testing the accuracy of the meter does not

produce pulses or signals corresponding to an energy of more than the

critical change value

- and in reasonable time after the disturbance the meter shall

- recover to operate within the MPE limits, and

- have all measurement functions safeguarded, and

- allow recovery of all measurement data present prior to the disturbance,

and

- not indicate a change in the registered energy of more than the critical

change value.

The critical change value in kWh is m ·Un ·I max · 10 –6

(m being the number of measuring elements of the meter, U n in Volts and I max

in Amps).

For overcurrent the critical change value is 1.5 %.

5. Suitability

Below the rated operating voltage the positive error of the meter shall not

exceed 10 %.

The display of the total energy shall have a sufficient number of digits to ensure

that when the meter is operated for 4 000 hours at full load (I = I max , U = U n and

PF = 1) the indication does not return to its initial value and shall not be able to

be reset during use.

In the event of loss of electricity in the circuit, the amounts of electrical energy

measured shall remain available for reading during a period of at least 4

months.

Running with no load

When the voltage is applied with no current flowing in the current circuit

(current circuit shall be open circuit), the meter shall not register energy at any

voltage between 0.8 Un and 1.1 Un.

Starting

The meter shall start and continue to register at Un, PF = 1 (polyphase meter

with balanced loads) and a current which is equal to I st

6. Units

The electrical energy measured shall be displayed in kilowatt-hours or in

megawatt-hours.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these

regulations that the manufacturer can choose between are

B + F or B + D or H1.

Schedule XIII

(Regulations 4 and 5)

HEAT METERS

The relevant requirements of Schedule I, the specific requirements and the conformity

assessment procedures listed in this Schedule, apply to heat meters defined below, intended

for residential, commercial and light industrial use.

DEFINITIONS

A heat meter is an instrument designed to measure the heat which, in a heat exchange circuit,

is given up by a liquid called the heat-conveying liquid.

A heat meter is either a complete instrument or a combined instrument consisting of the sub-

assemblies, flow sensor, temperature sensor pair, and calculator, as defined in regulation 5 of

these regulations, or a combination thereof

θ

= the temperature of the heat-conveying liquid;

θ in

= the value of θ at the inlet of the heat exchange circuit;

θ out

= the value of θ at the outlet of the heat exchange circuit;

= the temperature difference θ in - θ out with ∆ θ ≥ 0;

∆θ

θ max

= the upper limit of θ for the heat meter to function correctly within the MPEs;

= the lower limit of θ for the heat meter to function correctly within the MPEs;

= the upper limit of ∆θ for the heat meter to function correctly within the MPEs;

= the lower limit of ∆θ for the heat meter to function correctly within the MPEs;

= the flow rate of the heat conveying liquid;

= the highest value of q that is permitted for short periods of time for the heat

meter to function correctly;

= the highest value of q that is permitted permanently for the heat meter to

function correctly;

= the lowest value of q that is permitted for the heat meter to function correctly;

= the thermal power of the heat exchange;

= the upper limit of P that is permitted for the heat meter to function correctly.

SPECIFIC REQUIREMENTS

Rated operating conditions

The values of the rated operating conditions shall be specified by the

manufacturer as follows

For the temperature of the liquid: θ max , θ min ,

- for the temperature differences: ∆θ max , ∆θ min ,

subject to the following restrictions: ∆θ max / ∆θ min ≥ 10, ∆θ min = 3 K or 5

K or 10 K.

For the pressure of the liquid: The maximum positive internal pressure that the

heat meter can withstand permanently at the upper limit of the temperature.

For the flow rates of the liquid: q s , q p , q i , where the values of q p and qi are

subject to the following restriction: q p /q i ≥ 10

For the thermal power: Ps

Accuracy Class

The following accuracy classes are defined for heat meters: 1, 2, 3.

3. MPE’s applicable to complete heat meters

The maximum permissible relative errors applicable to a complete heat meter,

expressed in percent of the true value for each accuracy class, are

- For class 1: E = E f + E t + E c , with E f , E f , E c according to paragraphs 7.1

to 7.3.

-

For class 2: E = E f + E t + E c , with E f , E f , E c according to paragraphs 7.1

to 7.3.

-

For class 3: E = E f + E t + E c , with E f , E f , E c according to paragraphs 7.1

to 7.3.

4. Permissible effect of electromagentic disturbances

The instrument shall not be influenced by static magnetic fields and by

electromagnetic fields at mains frequency.

The influence of an electromagnetic disturbance shall be such that the change in

the measurement result is not greater than the critical change value as laid down

in requirement 4.3 or the indication of the measurement result is such that it

cannot be interpreted as a valid result.

The critical change value for a complete heat meter is equal to the absolute

value of the MPE applicable to that heat meter (see paragraph 3).

5. Durability

After an appropriate test, taking into account the period of time estimated by the

manufacturer, has been performed, the following criteria shall be satisfied

Flow sensors: The variation of the measurement result after the durability test,

when compared with the initial measurement result, shall not exceed the critical

change value.

Temperature sensors: The variation of the measurement result after the

durability test, when compared with the initial measurement result, shall not

exceed 0.1 °C.

6. Inscriptions on a heat meter

-

Accuracy class

-

Limits of flow rate

-

Limits of temperature

-

Limits of temperature difference

-

Place of the flow sensor installation: flow or return

-

Indication of the direction of flow

7. Sub-assemblies

The provisions for sub-assemblies may apply to sub-assemblies manufactured

by the same or different manufacturers. Where a heat meter consists of sub-

assemblies, the essential requirements for the heat meter apply to the sub-

assemblies as relevant. In addition, the following apply

The relative MPE of the flow sensor, expressed in %, for accuracy classes

- Class 1: E f = (1 + 0.01 q p /q), but not more than 5 %,

- Class 2: E f = (2 + 0.02 q p /q), but not more than 5 %,

- Class 3: E f = (3 + 0.05 q p /q), but not more than 5 %,

where the error E f relates the indicated value to the true value of the relationship

between flow sensor output signal and the mass or the volume.

The relative MPE of the temperature sensor pair, expressed in %

- E t = (0.5 + 3 ∆θ max / ∆θ min ),

where the error E t relates the indicated value to the true value of the relationship

between temperature sensor pair output and temperature difference.

The relative MPE of the calculator, expressed in %

- E c = (0.5 + ∆θ max / ∆θ min ),

where the error E c relates the value of the heat indicated to the true value of the

heat.

The critical change value for a sub-assembly of a heat meter is equal to the

respective absolute value of the MPE applicable to the sub-assembly (see

paragraphs 7.1, 7.2 or 7.3).

Inscriptions on the sub-assemblies

Flow sensor

Accuracy class

Limits of flow rate

Limits of temperature

Nominal meter factor (e.g. litres/pulse) or corresponding output

signal

Indication of the direction of flow

Temperature sensor pair

Type identification (e.g. Pt 100)

Limits of temperature

Limits of temperature difference

Calculator

Type of temperature sensors

- Limits of temperature

- Limits of temperature difference

- Required nominal meter factor (e.g. litres/pulse) or

corresponding input signal coming from the flow sensor

- Place of the flow sensor installation: flow or return

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these

regulations that the manufacturer can choose between are

B + F or B + D or H1.

Schedule XIV

(Regulations 4 and 5)

MEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC

MEASUREMENT OF QUANTITIES OF LIQUIDS OTHER THAN WATER

The relevant essential requirements of Schedule I, the specific requirements of this Schedule

and the conformity assessment procedures listed in this Schedule, apply to measuring

systems intended for the continuous and dynamic measurement of quantities (volumes or

masses) of liquids other than water. If appropriate, the terms 'volume, and L' in this Schedule

can be read as: 'mass and kg '.

DEFINITIONS

Meter

An instrument designed to measure continuously, memorise and display the quantity at

metering conditions of liquid flowing through the measurement transducer in a closed, fully

charged conduit.

Calculator

A part of a meter that receives the output signals from the measurement transducer(s) and

possibly, from associated measuring instruments and displays the measurement results.

Associated measuring instrument

An instrument connected to the calculator for measuring certain quantities which are

characteristic of the liquid, with a view to make a correction and/or conversion.

Conversion Device

using associated measuring instruments, or stored in a memory, automatically converts

- the volume of the liquid measured at metering conditions into a volume at base

conditions and/or into mass, or

- the mass of the liquid measured at metering conditions into a volume at metering

conditions and/or into a volume at base conditions

Note: A conversion device includes the relevant associated measuring instruments.

Base conditions

The specified conditions to which the measured quantity of liquid at metering conditions is

converted.

Measuring System

A system that comprises the meter itself and all devices required to ensure correct

measurement or intended to facilitate the measuring operations.

Fuel dispenser

A measuring system intended for the refuelling of motor vehicles, small boats and small

aircraft.

Self-service arrangement

An arrangement that allows the customer to use a measuring system for the purpose of

obtaining liquid for his own use.

Self-service device

A specific device that is part of a self-service arrangement and which allows one of more

measuring systems to perform in this self-service arrangement.

Minimum measured quantity (MMQ)

The smallest quantity of liquid for which the measurement is metrologically acceptable for

the measuring system.

Direct indication

The indication, either volume or mass, corresponding to the measure and that the meter is

physically capable of measuring.

Note: The direct indication may be converted into another quantity using a conversion

device.

Interruptible / non interruptible

A measuring system is considered as interruptible / non interruptible when the liquid flow

can/cannot be stopped easily and rapidly.

Flowrate range

The range between the minimum flowrate (Q min ) and maximum flowrate (Q max ).

SPECIFIC REQUIREMENTS

1.0.

Rated operating conditions

The manufacturer shall specify the rated operating conditions for the

instrument, in particular;

1.1

The flowrate range

The flowrate range is subject to the following conditions

(i)

the flowrate range of a measuring system shall be within

the flowrate range of each of its elements, in particular

the meter.

(ii)

meter and measuring system

Table 1

Specific measuring

Characteristic of liquid

Minimum ratio of

system

Q max : Q min

Fuel dispensers

Not Liquefied gases

10: 1

Liquefied gases

5:1

Measuring system

Cryogenic liquids

5:1

Measuring systems on

All liquids

Suitable for use

pipeline and systems for

loading ships

All other measuring

All liquids

4: 1

t

The properties of the liquid to be measured by the instrument by specifying the

name or type of the liquid or its relevant characteristics, for example

- Temperature range;

- Pressure range;

- Density range;

- Viscosity range.

The nominal value of the AC voltage supply and/or limits of the DC voltage

supply.

The base conditions for converted values.

Note

Paragraph 1.4 is without prejudice to the temperature requirements on mineral

oils or heavy fuel oils, or LPG or methane pursuant to the Import Duties Act

(Cap 337) and its subsidiary legislation.

Accuracy classification and maximum permissible errors (MPEs)

The following accuracy classes are defined for heat meters: 1, 2, 3.

For quantities equal to or greater than 2 litres the MPE on indications is

Table 2

Accuracy Class

0.3

0.5

1.0

1.5

2.5

Measuring systems (A)

0.5 %

0.5 %

1.0%

2.5 %

2.5 %

Meters (B)

0.3 %

0.6 %

0.6 %

1.5 %

1.5 %

For quantities less than two litres the MPE on indications is

Table 3

Measured volume V

MPE

V<0.l L

4 × value in Table 2, applied to 0.1 L

4 × value in Table 2

0.2L≤V<0.4L

2 × value in Table 2, applied to 0.4 L

0.4 L≤ V < 1 L

2 × value in Table 2

Value in Table 2, applied to 2 L

However, no matter what the measured quantity may be, the magnitude of the

MPE is given by the greater of the following two values

- the absolute value of the MPE given in Table 2 or Table 3,

- the absolute value of the MPE for the minimum measured quantity (E min ).

For minimum measured quantities greater than or equal to 2 litres the following

conditions apply

Condition 1

E min shall fulfil the condition: E min ≥ 2 R, where R is the smallest scale interval

of the indication device.

Condition 2

E min is given by the formula: E min = (2MMQ) × (A/100), where

- MMQ is the minimum measured quantity,

- A is the numerical value specified in line A of Table 2.

For minimum measured quantities of less than two litres, the above mentioned

condition 1 applies and E min is twice the value specified in Table 3, and related

to line A of Table 2.

Converted indication

In the case of a converted indication the MPEs are as in line A of Table 2.

Conversion devices

MPEs on converted indications due to a conversion device are equal to

± (A - B), A and B being the values specified in Table 2.

Parts of conversion devices that can be tested separately

(a) Calculator

MPEs on quantities of liquid indications applicable to calculation,

positive or negative, are equal to one-tenth of the MPEs as defined in

line A of Table 2.

(b) Associated measuring instruments

Associated measuring instruments shall have an accuracy at least as

good as the values in Table 4

Table 4

MPE

on

Accuracy classes of the measuring system

Measurements

0.3

0.5

1.0

1.5

2.5

Temperature

± 0.5 °C

± 1.0 °C

± 1.0 °C

Less than 1 MPa: ± 50

Pressure

kPa From 1 to 4

MPa: ± 5 % Over 4

MPa: ± 200 kPa

± 1 kg/m 3

± 2 kg/m 3

± 5 kg/m 3

Density

These values apply to the indication of the characteristic quantities of the liquid

displayed by the conversion device.

(c) Accuracy for calculating function

The MPE for the calculation of each characteristic quantity of the liquid,

positive or negative, is equal to two fifths of the value fixed in (b).

The requirement (a) in paragraph 2.6 applies to any calculation, not only

conversion.

3. Maximum permissible effect of disturbances

The effect of an electromagnetic disturbance on a measuring system shall be

one of the following;

- the change in the measurement result is not greater than the critical

change value as defined in paragraph 3.2, or

- the indication of the measurement result shows a momentary

variation that cannot be interpreted, memorised or transmitted as a

measuring result. Furthermore, in the case of an interruptible system,

this

can also mean the impossibility to perform any measurement, or

- the change in the measurement result is greater than the critical change

value, in which case the measuring system shall permit the retrieval of

the measuring result just before the critical change value occurred and

cut off the flow.

The critical change value is the greater of MPE/5 for a particular measured

quantity or E min .

4. Durability

After an appropriate test, taking into account the period of time estimated by the

manufacturer, has been performed, the following criterion shall be satisfied

The variation of the measurement result after the durability test, when compared

with the initial measurement result, shall not exceed the value for meters

specified in line B of table 2.

5. Suitability

For any measured quantity relating to the same measurement, the indications

provided by various devices shall not deviate one from another by more than

one scale interval where devices have the same scale interval. In the case where

the devices have different scale intervals, the deviation shall not be more than

that of the greatest scale interval.

However, in the case of a self-service arrangement the scale intervals of the

main indicating device on the measuring system and the scale intervals of the

self-service device shall be the same and results of measurement shall not

deviate one from another.

It shall not be possible to divert the measured quantity in normal conditions of

use unless it is readily apparent.

Any percentage of air or gas not easily detectable in the liquid shall not lead to a

variation of error greater than

-

0.5 % for liquids other than potable liquids and for liquids of a viscosity

not exceeding 1 mPa.s, or

-

1 % for potable liquids and for liquids of a viscosity exceeding 1 mPa.s.

However, the allowed variation shall never be smaller than 1 % of MMQ. This

value applies in the case of air or gas pockets.

Instruments for direct sales

A measuring system for direct sales shall be provided with means for resetting

the display to zero.

It shall not be possible to divert the measured quantity.

The display of the quantity on which the transaction is based shall be permanent

until all parties in the transaction have accepted the measurement result.

Measuring systems for direct sales shall be interruptible

Any percentage of air or gas in the liquid shall not lead to a variation of error

greater than the values specified in paragraph 5.3.

Fuel Dispensers

Displays on fuel dispensers shall not be capable of being reset to zero during a

measurement.

The start of a new measurement shall be inhibited until the display has been

reset to zero.

Where a measuring system is fitted with a price display, the difference between

the indicated price and the price calculated from the unit price and the indicated

quantity shall not exceed the price corresponding to E min . However this

difference need not be less than the smallest monetary value.

6. Power supply failure

A measuring system shall either be provided with an emergency power supply

device that will safeguard all measuring functions during the failure of the main

power supply device or be equipped with means to save and display the data

present in order to permit the conclusion of the transaction in progress and with

means to stop the flow at the moment of the failure of the main power supply

device.

8. Units of measurement

The metered quantity shall be displayed in millilitres, cubic centimetres, litres,

cubic metres, grams, kilograms or tonnes.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these

regulations that the manufacturer can choose between are

B + F or B + D or H1 or G

Schedule XV

(Regulations 4 and 5)

AUTOMATIC WEIGHING INSTRUMENTS

The relevant essential requirements of Schedule I, the specific requirements of this Schedule

and the conformity assessment procedures listed in Chapter I of this Schedule, apply to

automatic weighing instruments defined below, intended to determine the mass of a body by

using the action of gravity on that body.

DEFINITIONS

Automatic weighing instrument

An instrument that determines the mass of a product without the intervention of an operator

and follows a predetermined programme of automatic processes characteristic of the

instrument.

Automatic catchweigher

An automatic weighing instrument that determines the mass of pre-assembled discrete loads

(for example prepackages) or single loads of loose material.

Automatic checkweigher

An automatic catchweigher that subdivides articles of different mass into two or more

subgroups according to the value of the difference of their mass and a nominal set-point.

Weight labeller

An automatic catchweigher that labels individual articles with the weight value.

Weight/price labeller

An automatic catchweigher that labels individual articles with the weight value, and price

information.

Automatic gravimetric filling instrument

An automatic weighing instrument that fills containers with a predetermined and virtually

constant mass of product from bulk.

Discontinuous totaliser (totalising hopper weigher)

An automatic weighing instrument that determines the mass of a bulk product by dividing it

into discrete loads. The mass of each discrete load is determined in sequence and summed.

Each discrete load is then delivered to bulk.

Continuous totaliser

An automatic weighing instrument that continuously determines the mass of a bulk product

on a conveyor belt, without systematic subdivision of the product and without interrupting

the movement of the conveyor belt.

Rail-weighbridge

An automatic weighing instrument having a load receptor inclusive of rails for conveying

railway vehicles..

SPECIFIC REQUIREMENTS

CHAPTER I — Requirements common to all types of automatic weighing instruments

1.0.

Rated operating conditions

The manufacturer shall specify the rated operating conditions for the

instrument, in particular;

1.1

For the measurand

The measuring range in terms of its maximum and minimum capacity.

1.2

For the electrical supply influence quantities

In case of AC voltage supply: the nominal AC voltage supply, or the AC

voltage limits.

In case of DC voltage supply: the nominal and minimum DC voltage supply, or

the DC voltage limits.

For the mechanical and climatic influence quantities

The minimum temperature range is 30 °C unless specified otherwise in the

following chapters of this Schedule.

The mechanical environment classes according to Schedule I, paragraph 1.3.2

are not applicable. For instruments which are used under special mechanical

strain, e.g. instruments incorporated into vehicles, the manufacturer shall define

the mechanical conditions of use

For other influence quantities (if applicable)

The rate(s) of operation.

The characteristics of the product(s) to be weighed.

Permissible effect of disturbances — Electromagnetic environment

The required performance and the critical change value are given in the relevant

Chapter of this Schedule for each type of instrument.

3. Suitability

Means shall be provided to limit the effects of tilt, loading and rate of operation

such that maximum permissible errors (MPEs) are not exceeded in normal

operation.

Adequate material handling facilities shall be provided to enable the instrument

to respect the MPEs during normal operation.

Any operator control interface shall be clear and effective.

The integrity of the display (where present) shall be verifiable by the operator.

Adequate zero setting capability shall be provided to enable the instrument to

respect the MPEs during normal operation.

Any result outside the measurement range shall be identified as such, where a

printout is possible.

4. Conformity assessment

The conformity assessment procedures referred to in regulation 8 of these

regulations that the manufacturer can choose between are

For mechanical systems

B + D or B + E or B + F or D1 or F1 or G or H1.

For electromechanical instruments

B + D or B + E or B + F or G or H1.

For electronic systems or systems containing software

B + D or B + F or G or H1.

CHAPTER II — Automatic Catchweighers

1. Accuracy Classes

Instruments are divided into primary categories designated by

X or Y as specified by the manufacturer.

These primary categories are further divided into four accuracy classes

XI, XII, XIII & XIV

and

Y(I), Y(II), Y(a) & Y(b)

which shall be specified by the manufacturer.

2. Category X Instruments

Category X applies to instruments used to check prepackages made up in

accordance with the requirements of Prepackaged Liquid Prodcuts Regulations 1

(1)

, 2002 and of Making up by Weight or by Volume of Certain Prepacked

Products Regulations, 2002 applicable to prepackages. (2)2

The accuracy classes are supplemented by a factor (x) that quantifies the

maximum permissible standard deviation as specified in paragraph 4.2.

The manufacturer shall specify the factor (x), where (x) shall be ≤ 2 and in the

form 1 × 10 k , 2 × 10 k or 5 × 10 k , where k is a negative whole number or zero.

3. Category Y Instruments

Category Y applies to all other automatic catchweighers.

4. MPE

Mean error Category X / MPE Category Y instruments

Table 1

Maximum Maximum

permissible permissible

Net Load (m) in verification scale intervals (e)

mean error

error

XI

Y(I)

XII

Y(II)

XIII

Y(a)

XIV

Y(b)

X

Y

0 <m≤ 50 000

± 0.5 e

± 1 e

0 <m≤ 5 000

0 <m≤ 500

0<m≤ 50

50 000 <m≤ 200 000 5 000 < m ≤ 20 000

± 1.5 e

± 1.5 e

500<m≤2000

50<m≤200

200 000 < m

20 000 <m≤ 100 000

2 000<m≤10 000

200<m≤1000

± 1.5 e

±2 e

L.N. 415 of 2002

L.N. 417 of 2002

.

Standard deviation

Maximum permissible value for the standard deviation of a class X (x)

instrument is the result of the multiplication of the factor (x) by the value in

Table 2 below.

Net Load (m)

Maximum permissible standard deviation for class X(1)

m ≤ 50 g

0.48 %

50 g < m ≤ 1 00 g

0.24 g

100 g < m ≤ 2 00 g

0.24 %

200 g < m ≤ 3 00 g

0.48 g

300 g < m ≤ 5 00 g

0.16%

500 g < m ≤ 1 000 g

0.8 g

1 000 g < m ≤ 10 000 g

0.08 %

10 000 g < m ≤ 15 000 g

8g

15 000 g < m

0.053%

For class XI and XII (x) shall be less than 1.

For class XIII (x) shall be not greater than 1.

For class XIV (x) shall be greater than 1.

Verification scale interval — single interval instruments

Table 3

Accuracy classes

Verification scale

Number of verification scale

interval

intervals n = Max/e

Minimum

Maximum

0.001g ≤ e

XI

Y(I)

50 000

—

XII

Y(II)

0.001 g ≤ e ≤

100 000

0.05 g

0.1 g ≤ e

5 000

100 000

XIII

Y(a)

0.1 g ≤ e ≤ 2g

10 000

5g ≤ e

10 000

XIV

Y(b)

5 g ≤ e

.4. Verification scale interval — multi-interval instruments

Table 4

Number of verification scale

intervals n = Max/e

Verification scale

Accuracy classes

Minimum value (1)

Maximum value (1)

interval

n = Max i /e (i+1)

n = Max i /e (i+1)

XI

Y(I)

0.001g ≤ e i

50 000

—

0.001 g ≤ e i ≤

XII

Y(II)

5 000

100 000

0.05 g

0.1 g ≤ e i

5 000

100 000

0.1 g ≤ e i

XIII

Y(a)

10 000

5 g ≤ e i

XIV

Y(b)

Where

i = 1, 2, ...r

i = partial weighing range

r = total number of partial ranges

( 1 ) For i = r the corresponding column of Table 3 applies with e replaced by e r .

5. Measurement Range

In specifying the measurement range for class Y instruments the manufacturer

shall take account that the minimum capacity shall not be less than

class Y(I)

100 e

20 e for 0.001g ≤ e ≤ 0.05g, and

class Y(II)

50 e for 0.1g ≤ e

class Y(a)

20 e

class Y(b)

10 e

Scales used for grading,

5 e

e.g. postal scales and garbage

weighers

6. Dynamic Setting

The dynamic setting facility shall operate within a load range specified by the

manufacturer.

When fitted, a dynamic setting facility that compensates for the dynamic effects

of the load in motion shall be inhibited from operating outside the load range,

and shall be capable of being secured.

7. Performance Under Influence Factors And Electromagnetic Disturbances

The MPEs due to influence factors are

For category X instruments

- For automatic operation; as specified in Tables 1, and 2,

- For static weighing in non-automatic operation; as specified in Table 1.

For category Y instruments

- For each load in automatic operation; as specified in Table 1,

- For static weighing in non-automatic operation; as specified for category X

in Table 1.

The critical change value due to a disturbance is one verification scale interval.

Temperature range

-

For class XI and Y(I) the minimum range is 5° C,

-

For class XII and Y(II) the minimum range is 15° C.

CHAPTER III — Automatic Gravimetric Filling Instruments

1. Accuracy classes

The manufacturer shall specify both the reference accuracy class Ref(x) and the

operational accuracy class(es) X(x).

An instrument type is designated a reference accuracy class, Ref(x),

corresponding to the best possible accuracy for instruments of the type. After

installation, individual instruments are designated for one or more operational

accuracy classes, X(x), having taken account of the specific products to be

weighed. The class designation factor (x) shall be ≤ 2, and in the form 1 × 10 k ,

2 × 10 k or 5 × 10 k where k is a negative whole number or zero.

The reference accuracy class, Ref(x) is applicable for static loads.

For the operational accuracy class X(x), X is a regime relating accuracy to load

weight and (x) is a multiplier for the limits of error specified for class X(1) in

2.2.

2. MPE

Static weighing error

For static loads under rated operating conditions, the MPE for reference

accuracy class Ref(x), shall be 0.312 of the maximum permissible deviation of

each fill from the average; as specified in Table 5; multiplied by the class

designation factor (x).

For instruments where the fill may be made up from more than one load (e.g.

cumulative or selective combination weighers) the MPE for static loads shall be

the accuracy required for the fill as specified in 2.2 (i.e. not the sum of the

maximum permissible deviation for the individual loads).

Deviation from average fill

Table 5

Value of the mass, m (g), of Maximum permissible deviation of each fill from the average

the fills

for class X(1)

m ≤ 50

7.2%

50 < m ≤ 100

3.6 g

100 < m ≤ 200

3.6%

200 < m ≤ 300

7.2 g

300 < m ≤ 500

2.4 %

500 < m ≤ 1 000

12 g

1 000 < m ≤ 10 000

1.2%

10 000 < m ≤ 15 000

120 g

15 000 < m

0.8%

Note: The calculated deviation of each fill from the average may be adjusted to

take account for the effect of material particle size

Error relative to pre-set value (setting error)

For instruments where it is possible to pre-set a fill weight; the maximum

difference between the pre-set value and the average mass of the fills shall not

exceed 0.312 of the maximum permissible deviation of each fill from the

average, as specified in Table 5.

3. Performance Under Influence Factor And Electromagnetic Disturbance

The MPE due to influence factors shall be as specified in paragraph 2.1.

The critical change value due to a disturbance is a change of the static weight

indication equal to the MPE as specified in paragraph 2.1 calculated for the

rated minimum fill, or a change that would give equivalent effect on the fill in

the case of instruments where the fill consists of multiple loads. The calculated

critical change value shall be rounded to the next higher scale interval (d).

The manufacturer shall specify the value of the rated minimum fill.

CHAPTER IV — Discontinuous Totalisers

1. Accuracy Classes

Instruments are divided into four accuracy classes as follows: 0.2, 0.5, 1, 2.

2. MPE’s

Table 6

Accuracy class

MPE of totalised load

0.2

± 0.10%

0.5

± 0.25%

± 0.50 %

± 1.00 %

3. Totalisation scale interval

The totalisation scale interval (d t ) shall be in the range

0.01 % Max ≤ d t ≤ 0.2 % Max

4. Minimum Totalised Load (Σ min )

The minimum totalised load (Σ min ) shall be not less than the load at which the

MPE is equal to the totalisation scale interval (d t ) and not less than the

minimum load as specified by the manufacturer.

5. Zero Setting

Instruments that do not tare weigh after each discharge shall have a zero setting

device. Automatic operation shall be inhibited if zero indication varies by

- 1 d t on instruments with automatic zero setting device;

- 0.5 d t on instruments with a semi-automatic, or non-automatic, zero

setting device.

6. Operator Interface

Operator adjustments and reset function shall be inhibited during automatic

operation.

7. Printout

On instruments equipped with a printing device, the reset of the total shall be

inhibited until the total is printed. The printout of the total shall occur if

automatic operation is interrupted

8. Performance under influence factors and electromagnetic disturbances

The MPEs due to influence factors shall be as specified in Table 7.

Table 7

Load (m) in totalisation scale

MPE

intervals (dt)

0 < m ≤ 500

± 0.5 d t

500 < m ≤ 2 000

± 1.0 d t

2 000 < m ≤ 10 000

± 1.5 d t

The critical change value due to a disturbance is one totalisation scale interval

for any weight indication and any stored total.

CHAPTER V — Continuous Totalisers

1. Accuracy classes

Instruments are divided into three accuracy classes as follows: 0.5, 1, 2.

2. Measurement Range

The manufacturer shall specify the measurement range, the ratio between the

minimum net load on the weighing unit and the maximum capacity, and the

minimum totalised load.

The minimum totalised load Σ min shall not be less than

800 d for class 0.5,

400 d for class 1,

200 d for class 2.

Where d is the totalisation scale interval of the general totalisation device

3. MPE

Table 8

Accuracy class

MPE for totalised load

0.5

± 0.25 %

± 0.5 %

± 1.0 %

4. Speed of the belt

The speed of the belt shall be specified by the manufacturer. For single-speed

beltweighers, and variable-speed beltweighers having a manual speed setting

control, the speed shall not vary by more than 5 % of the nominal value. The

product shall not have a different speed than the speed of the belt.

General Totalisation Device

It shall not be possible to reset the general totalisation device to zero.

6. Performance under influence factors and electromagnetic disturbances

The MPE due to influence factor, for a load not less than the Σ min , shall be 0.7

times the appropriate value specified in Table 8, rounded to the nearest

totalisation scale interval (d).

The critical change value due to a disturbance shall be 0.7 times the appropriate

value specified in Table 8, for a load equal to Σ min , for the designated class of

the beltweigher; rounded up to the next higher totalisation scale interval (d).

CHAPTER VI — Automatic Rail Weighbridges

1. Accuracy classes

Instruments are divided into four accuracy classes as follows

0.2, 0.5, 1, 2.

2. MPE

The MPEs for weighing-in-motion of a single wagon or a total train are shown

in table 9.

Table 9

Accuracy class

MPE

0.2

± 0.1 %

0.5

± 0.25 %

± 0.5 %

± 1.0 %

The MPEs for the weight of coupled or uncoupled wagons weighing-in-motion

shall be one of the following values, whichever is the greatest

- the value calculated according to Table 9, rounded to the nearest scale

interval;

- the value calculated according to Table 9, rounded to the nearest scale

interval for a weight equal to 35 % of the maximum wagon weight (as

inscribed on the descriptive markings);

- one scale interval (d).

The MPEs for the weight of train weighing-in-motion shall be one of the

following values, whichever is the greatest

- the value calculated according to Table 9, rounded to the nearest scale

interval;

- the value calculated according to Table 9, for the weight of a single wagon

equal to 35 % of the maximum wagon weight (as inscribed on the

descriptive markings) multiplied by the number of reference wagons (not

exceeding 10) in the train, and rounded to the nearest scale interval;

- one scale interval (d) for each wagon in the train, but not exceeding 10 d.

When weighing coupled wagons; the errors of not more than 10 % of the

weighing results taken from one or more passes of the train may exceed the

appropriate MPE given in paragraph 2.2, but shall not exceed twice the MPE.

3. Scale interval (d)

The relationship between the accuracy class and the scale interval shall be as

specified in Table 10.

Table 10

Accuracy class

Scale interval (d)

d ≤ 50 kg

0.2

d ≤ 100 kg

0.5

d ≤ 200 kg

d ≤ 500 kg

4. Measurement range

The minimum capacity shall not be less than 1 t, and not greater than the value

of the result of the minimum wagon weight divided by the number of partial

weighings.

The minimum wagon weight shall not be less than 50 d.

5. Performance under influence factor and electromagnetic disturbance

The MPE due to an influence factor shall be as specified in Table 11.

Table 11

Load (m) in verification scale

MPE

intervals (d)

0 < m ≤ 500

±0.5d

500 < m ≤ 2 000

± 1.0 d

2 000 < m ≤ 10 000

± 1.5 d

The critical change value due to a disturbance is one scale interval.

Schedule XVI

(Regulations 4 and 5)

TAXIMETERS

The relevant requirements of Schedule 1, the specific requirements of this Schedule and the

conformity assessment procedures listed in this Schedule apply to taximeters.

DEFINITIONS

Taximeter

A device that works together with a signal generator ( 1 ) 1 to make a measuring instrument.

This device measures duration, calculates distance on the basis of a signal delivered by the

distance signal generator. Additionally, it calculates and displays the fare to be paid for a trip

on the basis of the calculated distance and/or the measured duration of the trip.

Fare

The total amount of money due for a trip based on a fixed initial hire fee and/or the length

and/or the duration of the trip. The fare does not include a supplement charged for extra

services.

Cross-over speed

The speed value found by division of a time tariff value by a distance tariff value.

Normal calculation mode S (single application of tariff)

Fare calculation based on application of the time tariff below the cross-over speed and

application of the distance tariff above the cross-over speed.

1 1

( ) The distance signal generator is outside the scope of these Regulations.

Normal calculation mode D (double application of tariff)

Fare calculation based on simultaneous application of time tariff and distance tariff over the

Operating position

The different modes in which a taximeter fulfils the different parts of its functioning. The

operating positions are distinguished by the following indications

'For Hire' The operating position in which the fare calculation is disabled

'Hired'

The operating position in which the fare calculation takes place on the

basis of a possible initial charge and a tariff for distance travelled and/or

time of the trip

'Stopped'

The operating position in which the fare due for the trip is indicated and at

least the fare calculation based on time is disabled.

DESIGN REQUIREMENTS

1. The taximeter shall be designed to calculate the distance and to measure the

duration of a trip.

2. The taximeter shall be designed to calculate and display the fare, incrementing

in steps equal to the resolution fixed by the Minister responsible for Transport

in the operation position 'Hired'. The taximeter shall also be designed to display

the final value for the trip in the operating position 'Stopped'.

3. A taximeter shall be able to apply the normal calculation modes S and D. It

shall be possible to choose between these calculation modes by a secured

setting.

4. A taximeter shall be able to supply the following data through an appropriate

secured interface(s)

- operation position: 'For Hire', 'Hired' or 'Stopped';

- totaliser data according to paragraph 15.1;

- general information: constant of the distance signal generator, date of

securing, taxi identifier, real time, identification of the tariff;

- fare information for a trip: total charged, fare, calculation of the fare,

supplement charge, date, start time, finish time, distance travelled;

tariff(s) information: parameters of tariff(s).

National legislation may require certain devices to be connected to the

interface(s) of a taximeter. Where such a device is required; it shall be possible,

by secured setting, to inhibit automatically the operation of the taximeter for

reasons of the non-presence or improper functioning of the required device.

5. If relevant, it shall be possible to adjust a taximeter for the constant of the

distance signal generator to which it is to be connected and to secure the

adjustment.

RATED OPERATING CONDITIONS

The mechanical environment class that applies is M3.

The manufacturer shall specify the rated operating conditions for the

instrument, in particular

-

a minimum temperature range of 80 °C for the climatic environment;

-

the limits of the DC power supply for which the instrument has been

designed.

MAXIMUM PERMISSIBLE ERRORS (MPEs)

7. The MPE, excluding any errors due to application of the taximeter in a taxi, are

- For the time elapsed: ± 0.1 %

minimum value of mpe: 0.2s;

- For the distance travelled: ± 0.2 %

minimum value of mpe: 4 m;

- For the calculation of the fare: ± 0.1 %

minimum, including rounding: corresponding to the least significant digit of the

fare indication.

PERMISSIBLE EFFECT OF DISTURBANCES

8. Electromagnetic immunity

The electromagnetic class that applies is E3.

The MPE laid down in paragraph 7 shall also be respected in the presence of an

electromagnetic disturbance.

POWER SUPPLY FAILURE

9. In case of a reduction of the voltage supply to a value below the lower operating

limit as specified by the manufacturer, the taximeter shall

- continue to work correctly or resume its correct functioning without loss of

data available before the voltage drop if the voltage drop is temporary, i.e.

due to restarting the engine;

- abort an existing measurement and return to the position 'For Hire' if the

voltage drop is for a longer period.

OTHER REQUIREMENTS

10. The conditions for the compatibility between the taximeter and the distance

signal generator shall be specified by the manufacturer of the taximeter.

11. If there is a supplement charge for an extra service, entered by the driver on

manual command, this shall be excluded from the fare displayed. However, in

that case a taximeter may display temporarily the value of the fare including the

supplementary charge.

12. If the fare is calculated according to calculation mode D a taximeter may have

an additional display mode in which only the total distance and duration of the

trip are displayed in real time.

13. All values displayed for the passenger shall be suitably identified. These values

as well as their identification shall be clearly readable under daylight and night

conditions.

If the fare to be paid or the measures to be taken against fraudulent use can be

affected by the choice of functionality from a pre-programmed setting or by free

data setting, it shall be possible to secure the instrument settings and data

entered.

The securing possibilities available in a taximeter shall be such that separate

securing of the settings is possible.

The provisions in paragraph 8.3 of Schedule I apply also to the tariffs

A taximeter shall be fitted with non-resettable totalisers for all of the following

values

- The total distance travelled by the taxi;

- The total distance travelled when hired;

- The total number of hirings;

- The total amount of money charged as supplements;

- The total amount of money charged as fare.

The totalised values shall include the values saved according to paragraph 9

under conditions of loss of power supply.

If disconnected from power, a taximeter shall allow the totalised values to be

stored for one year for the purpose of reading out the values from the taximeter

to another medium.

Adequate measures shall be taken to prevent the display of totalised values from

being used to deceive passengers

16. Automatic change of tariffs is allowed due to the

- distance of the trip;

- duration of the trip;

- time of the day;

- date;

- day of the week.

17. If properties of the taxi are important for the correctness of the taximeter, the

taximeter shall provide means to secure the connection of the taximeter to the

taxi in which it is installed.

18. For the purpose of testing after installation, the taximeter shall be equipped with

the possibility to test separately the accuracy of time and distance measurement

and the accuracy of the calculation.

19. A taximeter and its installation instructions specified by the manufacturer shall

be such that, if installed according to the manufacturer's instructions, fraudulent

alterations of the measurement signal representing the distance travelled are

sufficiently excluded.

20. The general essential requirement dealing with fraudulent use shall be fulfilled

in such a way that the interests of the customer, the driver, the driver's employer

and the fiscal authorities are protected.

21. A taximeter shall be designed so that it can respect the MPEs without

adjustment during a period of one year of normal use.

22. The taximeter shall be equipped with a real-timeclock by means of which the

time of the day and the date are kept, one or both can be used for automatic

change of tariffs. The requirements for the real-time clock are

- The timekeeping shall have an accuracy of 0.02 %;

- The correction possibility of the clock shall be not more than 2 minutes

per week. Correction for summer and wintertime shall be performed

automatically;

- Correction, automatic or manually, during a trip shall be prevented.

23. The values of distance travelled and time elapsed, when displayed or printed in

accordance with these regulations, shall use the following units

Distance travelled

- kilometres.

Time elapsed

- seconds, minutes or hours, as may be suitable; keeping in mind the

necessary resolution and the need to prevent misunderstandings

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these regulations that the

manufacturer can choose between are: B + F or B + D or H1.

Schedule XVII

(Regulations 4 and 5)

MATERIAL MEASURES

CHAPTER I — Material measures of length

The relevant essential requirements of Schedule I, the specific requirements of this Schedule

and the conformity assessment procedures listed in this chapter, apply to material measures

of length defined below. However, the requirement for the supply of a copy of declarations

of conformity may be interpreted as applying to a batch or consignment rather than each

individual instruments.

DEFINITIONS

Material measure of length

An instrument comprising scale marks whose distances are given in legal units of length.

SPECIFIC REQUIREMENTS

Reference Conditions

For tapes of length equal to or greater than five metres, the maximum

permissible errors (MPEs) are to be met when a tractive force of fifty newtons

or other force values as specified by the manufacturer and marked on the tape

accordingly, or in the case of rigid or semi-rigid measures no tractive force is

needed, is applied.

The reference temperature is 20 °C unless otherwise specified by the

manufacturer and marked on the measure accordingly.

2. The MPE, positive or negative in mm, between two non-consecutive scale

marks is (a + bL), where

- L is the value of the length rounded up to the next whole metre; and

- a and b are given in Table 1 below.

When a terminal interval is bounded by a surface, the MPE for any distance

beginning at this point is increased by the value c given in Table 1.

Table 1

Accuracy Class

a (mm)

b

c (mm)

I

0.1

0.1

0.1

II

0.3

0.2

0.2

III

0.6

0.4

0.3

D — special class

1.5

zero

zero

for dipping tapes ( 1 )

Up to and including

30 m( 2 )

S — special class for

1.5

zero

zero

tank strapping tapes

For each 30 m

length when the

tape is supported

on a flat surface

( 1 )

Applies to the tape/dip weight combinations.

( )

If the nominal tape length exceeds 30 m, an additional mpe of 0.75 mm

shall be permitted for each 30 m of tape length.

Dip tapes may also be of Classes I or II in which case for any length between

two scale marks, one of which is on the sinker and the other on the tape, the

mpe is ± 0.6 mm when application of the formula gives a value of less than 0.6

mm.

The MPE for the length between consecutive scale marks, and the maximum

permissible difference between two consecutive intervals, are given in Table 2

below.

Table 2

Length i of the

MPE or difference in millimetres according to

interval

accuracy class

I

II

III

i ≤ 1 mm

0.1

0.2

0.3

1 mm < i ≤ 1 cm

0.2

0.4

0.6

Where a rule is of the folding type, the jointing shall be such as not to cause any

errors, supplementary to those above, exceeding: 0.3 mm for Class II, and 0.5

mm for Class III.

Materials used for material measures shall be such that length variations due to

temperature excursions up to ± 8 °C about the reference temperature do not

exceed the MPE. This does not apply to Class S and Class D measures where

the manufacturer intends that thermal expansion corrections shall be applied to

observed readings where necessary.

Measures made from material whose dimensions may alter materially when

subjected to a wide range of relative humidity, may only be included in Classes

II or III.

4. The nominal value shall be marked on the measure. Millimetre scales shall be

numbered every centimetre and measures with a scale interval greater than 2 cm

shall have all scale marks numbered.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these regulations that the

manufacturer can choose between are

F 1 or D1 or B + D or H or G.

CHAPTER II — Capacity serving measures

The relevant essential requirements of Schedule I, and the specific requirements and the

conformity assessment procedures listed in this chapter, apply to capacity serving measures

defined below. However, the requirement for the supply of a copy of declarations of

conformity may be interpreted as applying to a batch or consignment rather than each

individual instrument. Also, the requirement for the instrument to bear information in

respect of its accuracy shall not apply.

DEFINITIONS

Capacity serving measure

A capacity measure (such as a drinking glass, jug or thimble measure) designed to determine

a specified volume of a liquid (other than a pharmaceutical product) which is sold for

immediate consumption.

Line measure

A capacity serving measure marked with a line to indicate nominal capacity.

Brim measure

A capacity serving measure for which the internal volume is equal to the nominal capacity.

Transfer measure

A capacity serving measure from which it is intended that the liquid is decanted prior to

consumption.

Capacity

The capacity is the internal volume for brim measures or internal volume to a filling mark for

line measures.

SPECIFIC REQUIREMENTS

1. Reference Conditions

Temperature: the reference temperature for measurement of capacity is 20 °C.

Position for correct indication: free standing on a level surface.

2. MPEs

Table 1

Line

Brim

Transfer measures

<100 ml

±2 ml

-0

+ 4 ml

> 100 ml

± 3%

-0

+ 6%

Serving measures

< 200 ml

±5%

-0

+ 10%

> 200 ml

±5 ml + 2.5 %

-0

+ 10 ml+ 5%

3. Materials

Capacity serving measures shall be made of material which is sufficiently rigid

and dimensionally stable to maintain capacity within the MPE.

4. Slope

Transfer measures shall be designed so that a change of contents equal to the

MPE causes a change in level of at least 2 mm at the brim or filling mark.

Transfer measures shall be designed so that the complete discharge of the liquid

being measured will not be impeded

5. Marking

The nominal capacity declared shall be clearly and indelibly marked on the

measure.

Capacity serving measures may also be marked with up to three clearly

distinguishable capacities, none of which shall lead to confusion one to the

other.

All filling marks shall be sufficiently clear and durable to ensure that MPEs are

not exceeded in use.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these regulations that the

manufacturer can choose between are

A1 or F1 or D1 or E1 or B + E or B + D or H.

Schedule XVIII

(Regulations 4 and 5)

DIMENSIONAL MEASURING INSTRUMENTS

The relevant essential requirements of Schedule I, the specific requirements of this Schedule

and the conformity assessment procedures listed in this Schedule, apply to dimensional

measuring instruments of the types defined below.

DEFINITIONS

Length measuring instrument

A length measuring instrument serves for the determination of the length of rope-type

materials (e.g. textiles, bands, cables) during feed motion of the product to be measured.

Area Measuring Instruments

An area measuring instrument serves for the determination of the area of irregular shaped

objects, e.g. for leather.

Multi-dimensional Measuring Instruments

A multi-dimensional measuring instrument serves for the determination of the edge length

(length, height, width) of the smallest enclosing rectangular parallelepiped of a product.

CHAPTER I — Requirements common to all dimensional measuring instruments

Electromagnetic immunity

1. The effect of an electromagnetic disturbance on a dimensional measuring

instrument shall be such that

- the change in measurement result is no greater than the critical change value

as defined in paragraph 2.3; or

- it is impossible to perform any measurement; or

- there are momentary variations in the measurement result that cannot be

interpreted, memorised or transmitted as a measuring result; or

- there are variations in the measurement result severe enough to be noticed

by all those interested in the measurement result.

2. The critical change value is equal to one scale interval

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these regulations that the

manufacturer can choose between are

For mechanical or electromechanical instruments

F1 or E1 or D1 or B + F or B + E or B + D or H or H1 or G.

For electronic instruments or instruments containing software

B + F or B + D or H1 or G.

CHAPTER II — Length measuring instruments

Characteristics of the product to be measured

1. Textiles are characterised by the characteristic factor K. This factor takes the

stretchability and force per unit area of the product measured into account and

is defined by the following formula

K = ε · (G A + 2.2 N/m 2 ), where

ε is the relative elongation of a cloth specimen 1 m wide at a tensile force of

10N,

G A is the weight force per unit area of a cloth specimen in N/m 2 .

Operating conditions

Range

Dimensions and K-factor, where applicable, within the range specified by the

manufacturer for the instrument. The ranges of K-factor are given in Table 1

Table 1

Group

Range of K

Product

I 0 < K < 2 × 10 -2 N/m 2

I

low stretchability

2 × 10 -2 N/m 2 < K < 8 × 10 -2 N/m 2

II

medium stretchability

8 × 10 -2 N/m 2 < K < 24 × 10 -2 N/m 2

III

high stretchability

24 × 10 -2 N/m 2 <K

IV

very high stretchability

Where the measured object is not transported by the measuring instrument, its

speed must be within the range specified by the manufacturer for the

instrument.

If the measurement result depends on the thickness, the surface condition and

the kind of delivery (e.g. from a big roll or from a pile), corresponding

limitations are specified by the manufacturer.

3. Instrument

Table 2

Accuracy class

MPE

I

0.125 %, but not less than 0.005 L m

II

0.25 %, but not less than 0.01 L m

III

0.5 %, but not less than 0.02 L m

Where Lm is the minimum measurable length, that is to say the smallest length

specified by the manufacturer for which the instrument is intended to be used.

The true length value of the different types of materials should be measured

using suitable instruments (e.g. tapes of length). Thereby, the material which is

going to be measured should be laid out on a suitable underlay (e.g. a suitable

table) straight and unstretched.

Other requirements

4. The instruments must ensure that the product is measured unstretched according

to the intended stretchability for which the instrument is designed..

CHAPTER III — Area measuring instruments

Operating Conditions

SPECIFIC REQUIREMENTS

Range

Dimensions within the range specified by the manufacturer for the instrument

Condition of the product

The manufacturer shall specify the limitations of the instruments due to the

speed, and thickness of the surface conditions if relevant, of the product.

2. Instrument

The MPE is 1.0 %, but not less than 1 dm 2 .

Other requirements

3. Presentation of the product

In the case of pulling back or stopping the product, it should not be possible to

have an error of measurement or the display must be blanked.

4. Scale interval

The instruments must have a scale interval of 1.0 dm 2 . In addition, it must be

possible to have a scale interval of 0.1 dm 2 for testing purposes

CHAPTER IV — Multidimensional measuring instruments

Operating conditions

Range

Dimensions within the range specified by the manufacturer for the instrument.

Minimum dimension

The lower limit of the minimum dimension for all values of the scale interval is

given in Table 1.

Table 1

Scale interval (d)

Minimum dimension (min)

(lower limit)

d ≤ 2 cm

10 d

2 cm < d ≤ 10 cm

20 d

10 cm < d

50 d

1.3.

Speed of the product

The speed must be within the range specified by the manufacturer for the

instrument

MPE

2. Instrument

MPE is ± 1.0 d.

Schedule XIX

(Regulations 4 and 5)

EXHAUST GAS ANALYSERS

The relevant essential requirements of Schedule I, the specific requirements of this Schedule

and the conformity assessment procedures listed in this Schedule, apply to exhaust gas

analysers defined below intended for inspection and professional maintenance of motor

vehicles in use.

DEFINITIONS

Exhaust gas analyser

An exhaust gas analyser is a measuring instrument that serves to determine the volume

fractions of specified components of the exhaust gas of a motor vehicle engine with spark

ignition at the moisture level of the sample analysed.

These gas components are carbon monoxide (CO), carbon dioxide (CO 2 ), oxygen (O 2 ) and

hydrocarbons (HC).

The content of hydrocarbons has to be expressed as concentration of n-hexane (C 6 H 14 ),

measured with near-infrared absorption techniques.

The volume fractions of the gas components are expressed as a percentage (% vol) for CO,

CO 2 and O 2 and in parts per million (ppm vol).

Moreover, an exhaust gas analyser calculates the lambda value from the volume fractions of

the components of the exhaust gas.

Lambda is a dimensionless value representative of the burning efficiency of an engine in

terms of air/fuel ratio in the exhaust gases. It is determined with a reference standardised

SPECIFIC REQUIREMENTS

Instrument Classes

1. Two classes (0 and I) are being defined for exhaust gas analysers. The relevant

minimum measuring ranges for these classes are shown in Table 1.

Table 1

Classes and measuring ranges

Parameter

Classes 0 and I

CO fraction

from 0 to 5 % vol

CO 2 fraction

from 0 to 16% vol

HC fraction

from 0 to 2 000 ppm vol

O 2 fraction

from 0 to 21 % vol

λ

from 0.8 to 1.2

Rated operating conditions

2. The values of the operating conditions shall be specified by the manufacturer as

follows

For the climatic and mechanical influence quantities

- A minimum temperature range of 35 °C for the climatic environment;

- The mechanical environment class that applies is M1.

For the electrical power influence quantities

- The voltage and frequency range for the AC voltage supply;

- The limits of the DC voltage supply.

For the ambient pressure

- The minimum and the maximum values of the ambient pressure are for

both classes: p min ≤ 860 hPa, pmax ≥ 1060 hPa.

Maximum permissible errors (MPEs)

3. The MPEs are defined as follows

For each of the fractions measured, the maximum error value permitted under

rated operating conditions according to paragraph 1.1 of Schedule I is the

greater of the two values shown in Table 2. Absolute values are expressed in %

vol or ppm vol, percentage values are percent of the true value.

Table 2

MPEs

Parameter

Class 0

Class I

CO fraction

± 0.03 % vol

± 0.06 % vol

± 5%

± 5%

CO 2 fraction

± 0.5 % vol

± 0.5 % vol

± 5%

± 5%

HC fraction

± 1 0 ppm vol

± 1 2 ppm vol

± 5%

± 5%

O 2 fraction

± 0,1 % vol

± 0,1 % vol

± 5%

± 5%

The MPE on lambda calculation is 0.3 %. The conventional true value is

calculated according to the formula defined in point 5.3.7.3 of Annex I of

Directive 98/69/EC of the EP and the Council relating to measures to be taken

against air pollution by emissions from motor vehicles and amending Council

Directive 70/220/EEC .

For this purpose, the values displayed by the instrument are used for

calculation.

Permissible effect of disturbances

4. For each of the volume fractions measured by the instrument, the critical

change value is equal to the MPE for the parameter concerned.

5. The effect of an electromagnetic disturbance shall be such that

-

either the change in the measurement result is not greater than the

critical change value laid down in paragraph 4;

-

or the presentation of the measurement result is such that it cannot be

taken for a valid result.

Other requirements

6. The resolution shall be equal to or of one order of magnitude higher than the

values shown in Table 3.

Table 3

Resolution

CO

CO 2

HC

( 1 )

Class 0 and class I

0 . 1 % vol

0.1 % vol

1 ppm vol

( 1 ) 0.01% vol. for measurand values below or equal to 4% vol, otherwise 0.1%

vol,

The lambda value shall be displayed with a resolution of 0.001.

7. The standard deviation of 20 measurements shall not be greater than one third

of the modulus of the MPE for each applicable gas volume fraction.

8. For measuring CO, CO 2 and HC, the instrument, including the specified gas

handling system, must indicate 95 % of the final value as determined with

calibration gases within 15 seconds after changing from a gas with zero content,

e.g. fresh air. For measuring O 2 , the instrument under similar conditions must

indicate a value differing less than 0.1 % vol from zero within 60 seconds after

changing from fresh air to an oxygen-free gas.

9. The components in the exhaust gas, other than the components whose values

are subject to the measurement, shall not affect the measurement results by

more than the half of the modulus of the MPEs when those components are

present in the following maximum volume fractions

6 % vol CO,

16% vol CO 2 ,

10% vol O 2 ,

5 % vol H 2 ,

0.3 % vol NO,

2 000 ppm vol HC (as n-hexane),

water vapor up to saturation.

10. An exhaust gas analyser shall have an adjustment facility that provides

operations for zero-setting, gas calibration and internal adjustment. The

adjustment facility for zero-setting and internal adjustment shall be automatic.

11. For automatic or semi-automatic adjustment facilities, the instrument shall be

unable to make a measurement as long as the adjustments have not been made.

12. An exhaust gas analyser shall detect hydrocarbon residues in the gas handling

system. It shall not be possible to carry out a measurement if the hydrocarbon

residues, present before any measurement, exceeds 20 ppm vol.

13. An exhaust gas analyser shall have a device for automatically recognising any

malfunctioning of the sensor of the oxygen channel due to wear or a break in

the connecting line.

14. If the exhaust gas analyser is capable to operate with different fuels (e.g. petrol

or liquefied gas), there shall be the possibility to select the suitable coefficients

for the Lambda calculation without ambiguity concerning the appropriate

formula.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in regulation 8 of these regulations that the

manufacturer can choose between are

B + F or B + D or H1.

Schedule XX

(Sub-Regulation 9(3))

The CE marking

The CE conformity marking must consist of the initials 'CE' taking the following form

If the CE marking is reduced or enlarged the proportions given in the above graduated

drawing must be respected.

Schedule XXI

(Regulation 7(1))

Table showing the Schedules and the corresponding

conformity assessment modules / procedures.

Schedule

Conformity Assessment Module/Procedure

II

A

IIa

III

B

IV

C

IVa

V

D

Va

VI

E

VIa

VII

F

VIIa

VIII

G

IX

H

IXa

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press