MEASURING INSTRUMENTS AND METHODS OF METROLOGICAL CONTROL REGULATIONS

SUBSIDIARY LEGISLATION 454.01

MEASURING INSTRUMENTS AND METHODS

OF METROLOGICAL CONTROL

REGULATIONS

15th September, 2006 *

LEGAL NOTICE 395 of 2002, as amended by Legal Notices 9 and 311 of

2008.

The title of these regulations is the Measuring Instruments

and Methods of Metrological Control Regulations.

For the purposes of these regulations, all the definitions in

the Malta Standards Authority Act shall apply, and in addition, in

these regulations, unless the context otherwise requires

"EEC initial verification" refers to the verification of a

measuring instrument which has not been verified previously as

referred to in regulation 11(1);

"verification of a measuring instrument" is the procedure which

includes the examination and marking and, or issuing of the

verification certificate which ascertains and confirms that the

measuring instrument complies with the statutory requirements.

(1) These regulations apply to goods referred to as

instruments, which include measuring instruments, components of

measuring instruments, additional devices and measurement

equipment.

(2) These regulations also apply to units of measurements, the

harmonization of methods of measurement and metrological

control and, where appropriate, the means required for application

of such methods.

(1) These regulations also apply to the prescription,

methods of measurement, metrological control and marking of

quantities of pre-packaged products.

The same value shall be attached to EEC pattern approval

and EEC initial verification as to the corresponding national

measures.

(2) The separate regulations concerning the subjects referred to

in regulation 3 shall specify in particular, the measurement

procedures and characteristics of, and the technical requirements

for, their design and functioning as regards the products referred to

in regulation 3(1) and (2) and the requirements concerning sub-

regulation (1).

*See regulation 1(2) of these regulations as originally promulgated, and Legal Notice

196 of 2006.

(1) EEC pattern approval of instruments constitutes their

admission to EEC initial verification and, where the latter is not

required, the authorization to place them on the market and, or put

them into service. If the separate regulations applicable to a

category of instruments exempt that category from EEC pattern

approval, the instruments in that category shall be admitted directly

to the EEC initial verification.

(2) If its control equipment so permits, the Authority shall

grant the EEC pattern approval for every instrument which satisfies

the requirements laid down in these regulations and the separate

regulations relating to the category of instruments in question.

(3) An application for the EEC pattern approval may be made

only by the manufacturer or his representative established in Malta.

For one and the same instrument, application may be made in Malta

only.

(4) When the Authority has granted the EEC pattern approval,

it shall take the necessary steps to ensure that it is kept informed of

any modification or addition to the approved pattern.

(5) In case of any such modification or addition to the approved

pattern, the Authority shall inform the other Member States of such

alterations.

(6) Modifications or additions to an approved pattern must

receive additional EEC pattern approval from the Authority, where

such changes influence or might influence measurement results or

the prescribed conditions for use of the instrument.

(7) However, in the case of a modified pattern, the new EEC

pattern approval shall be granted instead of an addition to the

original EEC pattern approval certificate, if the pattern is modified

after the provisions of these regulations or of the relevant special

regulations have been amended or adapted in such a way that the

modified pattern could be approved only pursuant to the new

provisions.

(8) The Authority shall grant the EEC pattern approval in

accordance with the provisions of these regulations and of the

relevant separate regulations.

(1) If its control equipment does not permit the granting of

EEC pattern approval, and in any other case, the Authority shall

recognise pattern approvals issued by other EEC type approval

bodies.

(2) When an instrument has successfully completed the EEC

pattern approval examination laid down in paragraph 2 of Annex 1

and in the separate regulations relating to it, the Authority shall

d r a w u p a ce r t i f i c at e c er t i f y i n g t h e E E C p a t t er n a p p r o v a l ,

hereinafter called "the EEC pattern approval certificate" and

forward it to the applicant. In the cases provided for in regulation

14 or in separate regulations, the applicant must, and in all other

cases he shall be entitled to, affix or cause to be affixed on each

instrument and all ancillary equipment conforming to the approved

pattern the approval sign shown in this certificate.

(1) The EEC pattern approval shall be valid for ten years.

It may be extended for successive periods of ten years and the

number of instruments which may be manufactured in accordance

with the approved pattern shall not be limited.

(2) EEC pattern approval is granted on the basis of the

provisions of these regulations and of separate regulations relating

to it and shall not be extended after the date of the entry into force

of any amendment to, or adaptation of, these provisions, in cases

where such EEC pattern approval could not have been granted on

the basis of these new provisions.

(3) When the EEC pattern approval is not extended, this

approval shall nevertheless continue to apply to instruments which

would have already been approved and are already in service.

(4) If its control equipment so permits, where use is made of

new techniques not provided for in separate regulations, the

Authority may grant EEC pattern approval with limited effect after

consultation with other type approval bodies.

(5)

It may include the following restrictions

(a) limit on the number of instruments which may be

covered by the approval,

(b) obligation to notify the competent authorities of the

place of installation,

(c) restrictions on use,

(d) special restrictions concerning the technique used.

(6) However, the Authority shall refuse to grant the limited

EEC pattern approval unless

(a) the separate regulations for

that

category

of

instruments has come into force,

(b) no derogation has been made from the maximum

permissible errors laid down in the separate

regulations.

The period of validity of such approval shall not exceed two

years. It may be extended by up to three years at most.

(7) In the event thai the Authority has granted the limited EEC

pattern approval referred to in subregulation (4), it shall take all

necessary steps to ensure that adjustment to technical progress is

made to the Annexes, and, where appropriate, to the separate

regulations as soon as it considers that a new technique has proved

to be satisfactory.

When EEC pattern approval is not required for a category

of instruments which meets the requirements of separate

regulations, the manufacturer may, on his own responsibility, affix

to the instruments in this category the special sign described in

paragraph 3.3 of Annex I.

(1) When the EEC pattern approval has been granted, the

Authority may withdraw it

(a) if instruments for which this approval was granted do

not conform to the approved pattern or to the

provisions of the relevant separate regulations;

(b) if the metrological requirements specified in the

certificate of approval or the provisions of regulation

8(4) are not met;

(c) if it ascertains that approval was granted in an

improper manner.

(2) When the EEC pattern approval has been granted, the

A u t h o r i t y m u s t w i t h d r a w i t i f t h e i n st r u m e n t s co n st r u c t e d

according to an approved pattern reveal in service a defect of a

general nature which makes them unsuitable for their intended use.

(3) If the Authority is informed of the occurrence of one of the

cases covered by subregulations (1) and (2), it shall likewise take

the measures provided for in those subregulations.

(4)

(a) If the Authority declares in writing that the case

referred to in subregulation (2) has arisen it may forbid

the placing on the market and putting into service of

the instruments concerned until further notice. The

Authority shall give the reasons underlying its decision

in its declaration. The same procedure shall apply in

the cases mentioned in subregulation (1) with respect

to instruments which have been exempted from EEC

initial verification, if the manufacturer, after due

warning, does not bring the instruments into line with

the approved pattern or with the requirements of the

relevant separate regulations.

(b) If the Authority declares that the case referred to in

subregulation (2) has arisen, it may forbid the placing

on the market and putting into service of the

instruments concerned until further notice. It shall

immediately inform the other interested parties, stating

the reasons on which its decision is based. The same

procedure shall apply in the cases mentioned in

subregulation (1), with respect to instruments which

have been exempted from EEC initial verification, if

the manufacturer, after due warning, does not bring the

instruments into line with the approved pattern or with

the requirements of the relevant separate regulations.

(c) If the body which granted the approval disputes that

the case referred to in subregulation (2) of which it has

been informed has arisen, or disputes that the measures

taken in pursuance of subregulation (4) are justified,

the body concerned and the Authority shall endeavour

to settle the dispute.

(1) EEC initial verification constitutes the examination of

a new or reconditioned instrument and the confirmation of its

conformity to the approved pattern and, or to the requirements of

these regulations and the separate regulations relating to the

instrument in question; it is certified by Authority EEC initial

verification mark.

(2) The EEC initial verification of instruments may be carried

out by a method other than unit checking in the cases specified in

the separate regulations and in accordance with the procedures

adopted.

(1) When an instrument is submitted to the Authority for

EEC initial verification, the Authority shall determine whether

(a) the instrument belongs to a category exempt from EEC

pattern approval and, if so, whether it satisfies the

technical construction and functioning requirements

laid down by the separate regulations relating to that

instrument;

(b) the instrument has received EEC pattern approval and,

if so, whether it conforms to the approved pattern, and

to the separate regulations relating to that instrument.

in force on the date of issue of the EEC pattern

approval,

(c) the examination carried out in the course of EEC

initial verification relates in particular to and in

accordance with the separate regulations

(i) the metrological characteristics;

(ii) the maximum permissible errors

(iii) the construction, in so far as this guarantees that

the measurement characteristics are not likely to

deteriorate to any great extent under normal

conditions of use;

(iv) the presence of prescribed inscriptions and

stamp plates or provisions for Authority

verification marking.

When an instrument has successfully undergone Authority

EEC initial verification, in accordance with the requirements of

these regulations and of the separate regulations, the Authority

partial or final verification marks described in Annex II shall be

affixed to that instrument in accordance with the rules laid down in

that Annex.

When the EEC initial verification is not required for a

category of instruments which meet the requirements of separate

regulations, the manufacturer shall, on his own responsibility, affix

to the instruments in that category the special symbol described in

paragraph 3.4 of Annex I.

The Authority shall take all necessary measures to prevent

the use on instruments of marks or inscriptions liable to be

confused with the Authority signs or marks.

(1) The Authority shall notify all interested parties of the

services, agencies and institutes which are duly authorized to carry

out the examination specified in these regulations and in the

separate regulations, to issue the certificates of EEC pattern

approval and to affix the Authority EEC initial verification marks.

(2) The separate regulations shall specify the control

requirements for instruments in service which bear signs or marks

and in particular the maximum errors permitted in service.

(3) Notwithstanding the provisions of regulation 3(1), an

instrument in service which bears Authority signs or marks but

does not satisfy the requirements of the relevant separate

regulations, in particular with regard to maximum permissible

e r r or s, m a y b e b an n ed f r om se r vi c e i n t h e sam e wa y a s an

instrument bearing national marks.

All decisions taken pursuant to these regulations and of the

separate regulations regarding the instruments in question and

refusing to grant or extend the EEC pattern approval, withdrawing

such approval, refusing to carry out the EEC initial verification or

prohibiting the placing on the market or entry into service shall

state the reasons on which they are based. Such refusal, withdrawal

or prohibition shall be notified to the party concerned, who shall at

the same time be informed of the remedies available to him under

the laws at the time in force in Malta and of the time limits allowed

for the exercise of such remedies.

MEASURING INSTRUMENTS

AND METHODS OF METROLOGICAL CONTROL

ANNEX I

Substituted by

L.N. 9 of 2008.

EEC PATTERN APPROVAL

1. Application for the EEC pattern approval

The application and the correspondence relating to it shall be drawn up

in English. The annexed documents shall be written in English.

The application shall contain the following information

the name and address of the manufacturer or the firm, or of his or its

authorised representative or of the applicant,

the category of instrument,

the intended use,

the measurement characteristics,

the commercial designation, if any, or the type.

The application shall be accompanied by the documents necessary for its

evaluation, in duplicate, and in particular

A description in particular of

i.

the construction and operation of the instrument,

ii.

the protecting arrangements ensuring correct working,

iii.

the devices for regulation and adjustment,

iv.

the intended locations for

a. verification marks

b. seals (where applicable).

General layout drawings and details of important components.

A schematic drawing illustrating the principles of operation and,

if necessary, a photograph.

The application shall be accompanied, where appropriate, by documents

relevant to the national approvals already granted.

Examination for EEC approval

The examination shall comprise

Study of the documents and an examination of the measurement

characteristics of the pattern in the laboratories of the

metrological service, in approved laboratories or at the place of

manufacture, delivery or installation

If the measurement characteristics of the pattern are known in

detail, only an examination of the documents submitted is

required.

The examination shall cover the entire performance of the instruments

under normal conditions of use. Under such conditions, these instruments must

maintain the measurement characteristics required.

The nature and scope of the examination mentioned in paragraph 2.1 may

be specified by separate regulations.

3. The EEC certificate and sign of approval

MEASURING INSTRUMENTS

AND METHODS OF METROLOGICAL CONTROL

3.1.

The certificate shall give results of the examination of the pattern and

shall specify the other requirements which must be complied with, if any. It shall be

accompanied by descriptions, drawings and diagrams necessary to identify the

pattern and to explain its functioning. The sign of approval provided for in

regulation 4 shall be a stylised letter E containing

•

in the upper part, the sign for Malta.

•

in the lower part, a designation to be determined by the

metrological service which granted approval (an identification

number).

An example of this approval sign is shown in paragraph 6.1.

3.2.

In the case of the limited approval, the letter P, having the same

dimensions as the stylised letter E, shall be placed before this letter.

An example of this limited approval sign is shown in paragraph 6.2.

3.3.

The sign mentioned in regulation 6 is the same as the Authority approval

sign, except that the stylised letter E is reversed symmetrically about a vertical axis

and bears no other indication unless the separate regulations stipulate otherwise.

3.4.

The sign mentioned in regulation 11 is the same as the Authority

approval sign is a hexagon.

An example of this sign is shown in paragraph 6.4.

3.5.

The signs mentioned in the previous paragraphs and affixed by the

manufacturer in accordance with the provisions of these regulations must be affixed

at a visible point of each instrument and all ancillary equipment submitted for

verification, and must be legible and indelible. If their affixation presents technical

difficulties, exceptions may be made in separate regulations or accepted after the

Authority considers the individual case.

4. Depositing of a sample instrument

In the cases mentioned by separate regulations, the service which granted the

approval may, if it considers this necessary, request the deposition of the sample

instrument for which approval has been granted. Instead of this sample instrument,

the service may authorise the depositing of parts of the instrument, of scale models

or of drawings, and will mention this on the Authority certificate of approval.

5. Announcement of approval

5.1.

EEC pattern approval and limited EEC pattern approvals shall be

published in a special Annex to the Gazette. The same applies to the Authority

additional EEC pattern approvals.

5.2.

At the same time as the party concerned is notified, copies of the

Authority certificate of approval shall be sent to the Commission and to the other

Member States; the latter can also obtain copies of the reports of the metrological

examinations if they wish.

5.3.

Withdrawal of EEC pattern approval and other communications

concerning the extent and validity of EEC pattern approval shall also be subject to

the announcement procedure mentioned in paragraphs 5.1 and 5.2.

6. Signs relative to EEC pattern approval

6.1.

Sign of the EEC pattern approval

MEASURING INSTRUMENTS

AND METHODS OF METROLOGICAL CONTROL

Example

EEC pattern approval granted by the Metrology Directorate of the Republic of

Malta in 2002 (see paragraph 3.1, first indent)

Identification number of the EEC pattern approval (see paragraph 3.1, second

indent)

6.2.

Sign of limited EEC pattern approval (see paragraph 3.2)

Example

Limited EEC pattern approval granted by the Metrological Service of the Federal

Republic of Germany in 1971.

Identification number of the limited EEC pattern approval.

6.3.

Sign of exemption from the limited EEC pattern approval (see paragraph

3.3)

Example

6.4.

Sign of pattern of approval for instruments exempt from the EEC initial

verification (see paragraph 3.4)

Example

EEC pattern approval granted by the Metrological Service of the Federal Republic

of Germany in 1971.

Identification number of the EEC pattern approval.

ANNEX I

ANNEX II

EEC INITIAL VERIFICATION

1. General points.

The EEC initial verifications may be carried out in one or more stages

Subject to the provisions of the separate regulations

The EEC initial verification shall be carried out in one stage on

instruments that constitute a whole on leaving the factory, that is

to say instruments which, theoretically, can be transferred to

their place of installation without first having to be dismantled.

The EEC initial verification shall be carried out in two or more

stages for instruments whose correct functioning depends on the

conditions in which they are installed or used.

The first stage of the verification procedure must ensure, in

particular, that the instrument conforms to the approved pattern

or, in the case of instruments exempt from EEC pattern

approval, that they conform to the relevant provisions.

2. Place of the EEC initial verification

If the separate regulations do not specify the place where verification is

to be carried out, instruments which have to be verified in only one stage shall be

verified at the place chosen.

Instruments which have to be verified in two or more stages shall be

The last stage of verification shall be carried out at the place of

installation.

The other verification stages of a verification shall be carried

out as laid down in paragraph 2.1.

In particular, when the verification takes place outside the office of

verification of the Authority, it may require the applicant

to make available standards, appropriate means in material and

personnel for the execution of the verification,

to provide a copy of the Authority certificate of approval.

3. Marks of the EEC initial verification

Marks of the description of EEC initial verification.

Subject to the provisions of separate regulations, EEC initial

verifications marks which are affixed in accordance with this

paragraph shall be as follows

3.1.1.1.

The final verification mark shall be composed of two

stamps

(a)

the first consists of a letter 'e' containing

-

in the upper half, the distinguishing capital

MEASURING INSTRUMENTS

AND METHODS OF METROLOGICAL CONTROL

letter of the State where the EEC initial

verification is carried out, together, where

necessary, with one or two numbers

identifying a territorial subdivision;

-

in the lower half, the identification number

of the verifying agent or office;

(b)

the second stamp shall consist of the last two

digits of the year of the verification, in a

hexagon.

3.1.1.2.

The mark of partial verification shall consist solely

of the first stamp. It shall also serve as a seal.

Shape and dimensions of marks

The attached drawings show the shape, dimensions and outline

of the letters and numbers for the EEC initial verification marks

as laid down in paragraph 3.1.

Affixing the marks

The final verification mark shall be affixed at the appointed

location on the instrument when the latter has been completely

verified and is recognised to conform to the EEC requirements.

The partial verification mark of the Authority shall be affixed

3.3.2.1.

When verification is made in several stages on the

instrument or part of an instrument which fulfils the

conditions laid down for operations other than those

at the place of installation, at the place where the

stamp-date is affixed or in any other place specified

in the separate regulations.

3.3.2.2.

In all cases as a seal, in the places specified in the

separate regulations.

MEASURING INSTRUMENTS

AND METHODS OF METROLOGICAL CONTROL

MEASURING INSTRUMENTS

AND METHODS OF METROLOGICAL CONTROL

MEASURING INSTRUMENTS

AND METHODS OF METROLOGICAL CONTROL