Appliances Burning Gaseous Fuels Regulations, 2004

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,532, 23 ta’ Jannar, 2004

L.N. 28 of 2004

PRODUCT SAFETY ACT

(ACT NO. V OF 2001)

Appliances Burning Gaseous Fuels Regulations, 2004

IN exercise of the powers conferred by articles 38 to 40 of the

Product Safety Act, 2001, the Minister of Finance and Economic Affairs,

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

regulations>-

1. The title of these regulations is the Appliances Burning Citation and

Commencement.

Gaseous Fuels Regulations, 2004.

1.2. These regulations shall come into force on the date of

publication>

1.2.1. Provided that the requirements to provide information to

the European Commission referred to in regulation 7.6 of these

regulations shall come into force on the 1 st May, 2004.

1.

These regulations shall apply to>

Scope.

2.1.1. appliances burning gaseous fuels used for cooking, heating,

hot water production, refrigeration, lighting or washing and having,

where applicable, a normal water temperature not exceeding 105˚

hereinafter referred to as ‘appliances’. Forced draught burners and

heating bodies to be equipped with such burners will also be considered

as appliances.

2.1.2. safety devices, controlling devices or regulating devices

and sub-assemblies, other than forced draught burners and heating bodies

to be equipped with such burners separately marketed for trade use and

designed to be incorporated into an appliance burning gaseous fuel or

assembled to constitute such an appliance, hereinafter referred to as

‘fittings’.

2.2. Appliances specifically designed for use in industrial

processes carried out on industrial premises are excluded from the scope

defined in regulation 2.1 of these regulations.

In these regulations>

1.

3.1.1. “authorised representative” means any person (or

organisation) established in the Community or Malta who has been

appointed by the manufacturer to act on his behalf in carrying out certain

tasks required by these regulations<

3.1.2. “CE marking” means marking as set out in Annex III of

the Directive, which is set out in Schedule III to these regulations

following the relevant procedure for certification of conformity as laid

down in regulation 8 of these regulations<

3.1.3. “Community” means the European Community<

3.1.4. “gaseous fuel” means any fuel which is in a gaseous state

at a temperature of 15˚C and a pressure of 1 bar<

3.1.5. “Harmonised Standard” means a technical specification

adopted by the European Committee for Standardisation (CEN) or the

European Committee for Electrotechnical Standardisation (CENELEC)

or the European Telecommunications Standards Institute (ETSI), upon

a remit from the European Commission in accordance with Council

Directive 98#34#EC 1 of the European Parliament and of the Council

laying down a procedure for the provision of information in the field of

technical standards and regulations as amended by Directive 98#48#EC 2

of the European Parliament and of the Council, the reference of which

has been published in the OJEU<

3.1.6. “importer” means any person who places on the

Community or Maltese market and puts into service the product that is

covered by regulation 2.1 of theses regulations and imported from a

third country<

3.1.7. “manufacturer” means the person>

3.1.7.1 who is primarily responsible for the design and

construction of the product covered by regulation 2.1 of these regulations

with a view to placing it on the Community or Maltese market on

his#their behalf<

OJ No. L204, 21-07-98, P.37.

OJ No. L217, 05-08-98, P.18.

3.1.7.2 who is responsible for “re-building” or modifying an

existing product falling under regulation 2.1 of these regulations, and

who in so doing is creating an “as-new” product, with a view to placing

it on the Community or Maltese market on his#their behalf<

3.1.7.3. who takes responsibility for the appraisal of the design,

construction and any necessary modification of used imported products

falling under regulation 2.1 of these regulations and coming from third

countries<

3.1.8. “National Standard transposing the Harmonised Standard”

means a Standard issued by one of the members of

CEN#CENELEC#ETSI which is declared and noted to be identical to

the Harmonised Standard originally issued by CEN#CENELEC#ETSI,

the reference of which has been published in the OJEU<

3.1.9.

“normally used” means

- correctly installed and regularly serviced in accordance

with the manufacturer’s instructions,

- used with a normal variation in the gas quality and a normal

fluctuation in the supply pressure, and

- used in accordance with its intended purposes or in a way

which can be reasonably foreseen<

3.1.10. “notified body” means a body appointed by a Member

State and notified to the Commission and the other Member States,

assessed according to the criteria laid down in Annex V of the Directive,

set out in Schedule V hereto and appointed to carry out the procedures

referred to in Article 8 of the Directive and regulation 8 of these

regulations<

3.1.10.1. The names of such bodies are published in the OJEU<

3.1.10.2. Maltese notified bodies wishing to operate within the

scope of these regulations shall follow the procedure prescribed in the

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

2003<

3.1.11. “OJEU” means Official Journal of the European Union<

3.1.12. “placing on the market” means the initial action of making

available a product, falling under regulation 2.1 of these regulations,

for the first time on the Community or Maltese market with a view to

distribution or use in the Community or Malta<

3.1.12.1. “making available” means the transfer of the product

falling under regulation 2.1 of these regulations, irrespective of the legal

act on which the transfer is based (sale, loan, hire, lease, gift or ony

other type of legal instrument)<

3.1.13. “putting into service” means the first use of a product,

falling under regulation 2.1 of these regulations, in the Community or

Maltese territory by its end user<

3.1.14. “the Directive” means Council Directive 90#396#EEC 3

as amended by Council Directive 93#68#EEC 4 on the approximation of

the laws of the Member States relating to appliances burning gaseous

fuels.

1. The provisions of these regulations are applicable to imported

products falling under regulation 2.1 of these regulations, as well as

those manufactured for the local market.

4.2. The placing on the market and the putting into service of

appliances, falling under regulation 2.1 of these regulations, which

comply with all the provisions of these regulations, including the

conformity assessment procedures laid down in Chapter II of the

Directive and regulation 8 of these regulations, and which bear the CE

marking provided for in Article 10 of the Directive and regulation 6 of

these regulations, shall not be prohibited, restricted or impeded.

4.3. The placing on the market of fittings as referred to in

regulation 2.1 of these regulations, accompanied by a certificate as

referred to in Article 8 (4) of the Directive and regulation 8.4 of these

regulations shall not be prohibited, restricted or impeded.

1. Appliances referred to in regulation 2.1 of these regulations

may be placed on the market and put into service only if, when normally

used, they do not compromise the safety of persons, domestic animals

and property.

OJ No. L196, 26-07-90, P.15.

OJ No. L220, 30-08-93, P.15.

5.2. Appliances and fittings as referred to in regulation 2.1 of

these regulations shall satisfy the essential requirements applicable to

them set out in Annex I of the Directive, which is set out in Schedule I

to these regulations.

5.3. Appliances and fittings shall be presumed to comply with

these regulations when they conform to>

5.3.1. the national standards applicable to them implementing

the harmonised standards whose reference numbers have been published

in the OJEU<

5.3.2. the national standards applicable to them relating to those

areas in which no harmonised standards exist and which are regarded

as complying with the essential requirements.

5.4. The Malta Standards Authority shall communicate to the

Commission the texts of its national standards as referred to in regulation

5.3.2 of these regulations which it regards as complying with the essential

requirements referred to in Article 3 of the Directive and regulation 5.2

of these regulations.

1. The CE marking of conformity and the inscriptions set out CE marking of

conformity.

in Annex III of the Directive, which is set out in Schedule III to these

regulations shall be affixed in a visible, easily legible and indelible form

to the appliance or to a data plate attached to it.

6.1.1. The data plate shall be so designed that it cannot be re-

used.

6.2. The affixing of markings on the appliances which are likely

to deceive third parties as to the meaning and form of the CE marking

shall be prohibited.

6.2.1. Any other marking may be affixed to the appliance or to

the data plate provided that the visibility and legibility of the CE marking

is not hereby reduced.

6.3. Without prejudice to regulation 7 of these regulations>

6.3.1. where it is established that the CE marking has been affixed

unduly, the manufacturer or his authorized representative shall be obliged

to make the product comply as regards the provisions concerning the

CE marking and to end the infringement under conditions imposed by

the Director of Consumer Affairs<

6.3.2. where non-compliance continues, all appropriate measures

shall be taken to restrict or prohibit the placing on the market of the

appliance in question or to ensure that it is withdrawn from the market

in accordance with the procedures laid down in regulation 7 of these

regulations.

1. Where it is ascertained that normally used appliances bearing

the CE marking might compromise the safety of persons, domestic

animals or property, all appropriate action shall be taken to withdraw

those appliances from the market and prohibit or restrict their being

placed on the market.

7.2. Where an appliance which does not comply bears the CE

marking, appropriate action shall be taken against whomsoever has

affixed the mark.

7.3. The Consumer and Industrial Goods Directorate of the Malta

Standards Authority shall be immediately informed of any such measures

taken under regulations 7.1 and 7.2 above, indicating the reasons for

such decision and, in particular, whether non-conformity is due to>

(a) failure to meet the essential requirements referred to in

Article 3 of the Directive and regulation 5.2 of these regulations,

where the appliance does not correspond to the standards referred

to in Article 5(1) of the Directive and regulation 5.3 of these

regulations<

(b) incorrect application of the standards referred to in

Article 5(1) of the Directive and regulation 5.3 of these regulations<

(c) shortcomings in the standards referred to in Article 5

(1) of the Directive and regulation 5.3 of these regulations.

7.4. Any decision taken pursuant to these regulations which

restricts the placing on the market and the putting into service of

appliances shall state the exact grounds on which it is based.

7.4.1. Such a decision shall be notified as soon as possible to the

party concerned, who shall at the same time be informed of the legal

remedies available to him under the laws in force in Malta and of the

time limits to which such remedies are subject.

7.5. Competent Authorities shall communicate the types of gas

and corresponding supply pressures used on the Maltese territory to the

Consumer and Industrial Goods Directorate of the Malta Standards

Authority before the 1 st May, 2004.

7.5.1. They shall also communicate all changes in good time.

7.6. The Consumer and Industrial Goods Directorate of the Malta

Standards Authority shall immediately inform the Commission of any

measures taken in pursuance of regulations 7.1, 7.2 7.3, 7.4, 7.4.1, 7.5

and 7.5.1 of these regulations.

1. The means of certification of conformity of series- Certification of

conformity.

manufactured appliances shall be>

(a) the EC type-examination as referred to in section 1 of

Annex II of the Directive, which is set out in section 1 of Schedule

II to these regulations, and

(b) prior to their being placed on the market, at the choice of

the manufacturer>

- the EC declaration of conformity to type referred to in

section 2 of Annex II of the Directive, which is set out in

section 2 of Schedule II to these regulations, or

- the EC declaration of conformity to type (guarantee of

production quality) referred to in section 3 of Annex II of the

Directive, which is set out in section 3 of Schedule II to these

regulations, or

- the EC declaration of conformity to type (guarantee of

product quality) referred to in section 4 of Annex II of the

Directive, which is set out in section 4 of Schedule II to these

regulations, or

- EC verification as referred to in section 5 of Annex II

of the Directive, which is set out in section 5 of Schedule II

to these regulations.

8.2. In the case of production of an appliance as a single unit or

in small quantities, EC verification by single unit, as referred to in section

6 of Annex II of the Directive, which is set out in section 6 of Schedule

II to these regulations, may be chosen by the manufacturer.

8.3. After completion of the procedures referred to in regulations

8.1 (b) and 8.2 of these regulations, the CE marking of conformity shall

be affixed to conforming appliances in accordance with Article 10 of

the Directive and regulations 6.1 and 6.2 of these regulations.

8.4 The procedures referred to in regulation 8.1 of these

regulations shall be applied in respect of fittings as referred to in Article

1 of the Directive and regulation 2.1of these regulations, with the

exception of the affixing of the CE marking of conformity and, where

appropriate, the drawing-up of the declaration of conformity.

8.4.1 A certificate shall be issued declaring the conformity of

the fittings with the provisions of these regulations which apply to them

and stating their characteristics and how they must be incorporated into

an appliance or assembled to assist compliance with the essential

requirements applicable to finished appliances.

8.4.2. The certificate shall be supplied with the fitting.

8.5. Where the appliances are covered by other Directives dealing

with other aspects and specifying the affixing of the CE marking, the

latter shall indicate that the appliances are also presumed to conform to

the provisions of those other Directives.

8.5.1. However, where one or more of these Directives allow

the manufacturer, during a transitional period, to choose which

arrangements to apply, the CE marking shall indicate conformity to the

provisions only of those Directives applied by the manufacturer. In this

case, particulars of the Directives applied, as published in the OJEU,

must be given in the documents, notices or instructions required by the

Directives and accompanying such devices.

8.6. Records and correspondence relating to the means of

certification of conformity shall be drawn up in the official language(s)

of the Member State where the body responsible for carrying out these

procedures is established or in a language accepted by it.

1. The Appliances Burning Gaseous Fuels Order, 1996 are

1996. hereby being revoked.

Schedule I

Based on Annex I of the Directive

ESSENTIAL REQUIREMENTS

Preliminary remark

The obligations resulting from the essential requirements for appliances in this

Schedule also apply to fittings where the corresponding risk exists.

1. GENERAL CONDITIONS

1.1. Appliances must be so designed and built as to operate safely and present

no danger to persons, domestic animals or property when normally used as defined in

Article 1(4) of the Directive and regulation 3.1.9 of these regulations.

1.2. When placed on the market, all appliances must>

- be accompanied by technical instructions intended for the installer,

- be accompanied by instructions for use and servicing, intended for the user,

- bear appropriate warning notices, which must also appear on the packaging.

The instructions and warning notices must be in Maltese and#or English or in

any other language of the Community acceptable to the Maltese authorities.

1.2.1. The technical instructions intended for the installer must contain all the

instructions for installation, adjustment and servicing required to ensure that those

operations are correctly performed and that the appliance may be used safely. In

particular, the instructions must specify>

- the type of gas used,

- the gas supply pressure used,

- the flow of fresh air required>

- for the combustion air supply,

- to avoid the formation of dangerous unburned gas mixtures for appliances

not fitted with the device referred to in point 3.2.3,

- the conditions for the dispersal of combustion products,

- for forced draught burners and heating bodies intended to be equipped with

such burners, their characteristics, the requirements for assembly, to assist

compliance with the essential requirements applicable to finished appliances and,

where appropriate, the list of combinations recommended by the manufacturer.

1.2.2. The instructions for use and servicing intended for the user must contain

all the information required for safe use, and must in particular draw the user’s attention

to any restrictions on use.

1.2.3. The warning notices on the appliance and its packaging must clearly state

the type of gas used, the gas supply pressure and any restrictions on use, in particular

the restriction whereby the appliance must be installed only in areas where there is

sufficient ventilation.

1.3. Fittings intended to be part of an appliance must be so designed and built as

to fulfil correctly their intended purpose when incorporated in accordance with the

instructions for installation.

The instructions for installation, adjustment, operation and maintenance must be

provided with the fittings concerned.

2. MATERIALS

2.1. Materials must be appropriate for their intended purpose and must withstand

the technical, chemical and thermal conditions to which they will foreseeably be

subjected.

2.2. The properties of materials that are important for safety must be guaranteed

by the manufacturer or the supplier of the appliance.

3. DESIGN AND CONSTRUCTION

3.1.

General

3.1.1. Appliances must be so constructed that, when used normally, no instability,

distortion, breakage or wear likely to impair their safety can occur.

3.1.2. Condensation produced at the start-up and#or during use must not affect

the safety of appliances.

3.1.3. Appliances must be so designed and constructed as to minimize the risk

of explosion in the event of a fire of external origin.

3.1.4. Appliances must be so constructed that water and inappropriate air

penetration into the gas circuit does not occur.

3.1.5. In the event of a normal fluctuation of auxiliary energy, appliances must

continue to operate safely.

3.1.6. Abnormal fluctuation or failure of auxiliary energy or its restoration must

not lead to an unsafe situation.

3.1.7. Appliances must be so designed and constructed as to obviate hazards of

electrical origin. In the area in which it applies, compliance with the safety objectives

in respect of electrical hazards laid down in Directive 73#23#EEC 5 , as implemented in

Malta by the Low Voltage Electrical Equipment Regulations, 2002, shall be equivalent L.N. 367

of 2002.

to fulfilment of this requirement.

3.1.8. All pressurised parts of an appliance must withstand the mechanical and

thermal stresses to which they are subjected without any deformation affecting safety.

3.1.9. Appliances must be so designed and constructed that failure of a safety,

controlling or regulating device may not lead to an unsafe situation.

3.1.10. If an appliance is equipped with safety and controlling devices, the

functioning of the safety devices must not be overruled by that of the controlling devices.

3.1.11. All parts of appliances which are set or adjusted at the stage of

manufacture and which should not be manipulated by the user or the installer must be

appropriately protected.

3.1.12. Levers and other controlling and setting devices must be clearly marked

and give appropriate instructions so as to prevent any error in handling. Their design

must be such as to preclude accidental manipulation.

3.2.

Unburned gas release

3.2.1. Appliances must be so constructed that the gas leakage rate is not

dangerous.

3.2.2. Appliances must be so constructed that gas release during ignition and

re-ignition and after flame extinction is limited in order to avoid a dangerous

accumulation of unburned gas in the appliance.

OJ No L 77, 26-03-73, P.29.

3.2.3. Appliances intended to be used in indoor spaces and rooms must be fitted

with a special device which avoids a dangerous accumulation of unburned gas in such

spaces or rooms.

Appliances which are not fitted with such devices must be used only in areas

where there is sufficient ventilation to avoid a dangerous accumulation of unburned

gas.

Large-scale kitchen appliances and appliances powered by gas containing toxic

components must be equipped with the aforesaid device.

3.3. Ignition

Appliances must be so constructed that, when used normally>

- ignition and re-ignition is smooth,

- cross-lighting is assured.

3.4.

Combustion

3.4.1. Appliances must be so constructed that, when used normally, flame

stability is assured and combustion products do not contain unacceptable concentrations

of substances harmful to health.

3.4.2. Appliances must be so constructed that, when used normally, there will

be no accidental release of combustion products.

3.4.3. Appliances connected to a flue for the dispersal of combustion products

must be so constructed that in abnormal draught conditions there is no release of

combustion products in a dangerous quantity in the room concerned.

3.4.4. Independent flueless domestic heating appliances and flueless

instantaneous water heaters must not cause, in the room or space concerned, a carbon

monoxide concentration likely to present a danger to the health of persons exposed,

bearing in mind the foreseeable duration of their exposure.

3.5.

Rational use of Energy

Appliances must be so constructed as to ensure rational use of energy, reflecting

the state of the art and taking into account safety aspects.

3.6. Temperature

3.6.1. Parts of appliances which are intended to be placed in close proximity to

the floor or other surfaces must not reach temperatures which present a danger in the

surrounding area.

3.6.2. The surface temperature of knobs and levers of appliances intended to be

manipulated must not present a danger to the user.

3.6.3. The surface temperatures of external parts of appliances intended for

domestic use, with the exception of surfaces or parts which are associated with the

transmission of heat, must not under operating conditions present a danger to the user

and in particular to children, for whom an appropriate reaction time must be taken into

account.

3.7.

Foodstuffs and water used for sanitary purposes

Without prejudice to the Community rules in this area, materials and components

used in the construction of an appliance, which may come into contact with food or

water used for sanitary purposes, must not impair their quality.

Schedule II

Based on Annex II of the Directive

PROCEDURE FOR CERTIFICATION OF CONFORMITY

1. EC TYPE-EXAMINATION

1.1. The EC type-examination is that part of the procedure by which a notified

body checks and certifies that an appliance, representative of the production envisaged,

meets the provisions of these regulations which apply to it.

1.2. The application for type-examination must be lodged by the manufacturer

or his authorized representative with a single notified body.

1.2.1. The application must include>

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

by the authorized representative, his name and address,

- a written declaration that the application has not been lodged with any

other notified body,

- the design documentation, as described in Annex IV of the Directive, which

is set out in Schedule IV to these regulations.

1.2.2. The manufacturer must place at the disposal of the notified body an

appliance, representative of the production envisaged, hereinafter called ‘type’. The

notified body may request further samples of the type if needed for the test programme.

The type may additionally cover variants of the product provided that those variants

do not have different characteristics with respect to types of risk.

1.3.

The notified body must>

1.3.1. examine the design documentation and verify that the type has been

manufactured in conformity with the design documentation and identify the elements

which have been designed in accordance with the applicable provisions of the standards

referred to in Article 5 of the Directive and regulation 5.3 of these regulations and the

essential requirements of these regulations<

1.3.2. perform, or have performed, the appropriate examinations and#or tests to

check whether the solutions adopted by the manufacturer meet the essential requirements

where the standards referred to in Article 5 of the Directive and regulation 5.3 of these

regulations have not been applied<

1.3.3. perform, or have performed, the appropriate examinations and#or tests to

check whether the applicable standards have effectively been applied where the

manufacturer has chosen to do so, thereby assuring conformity with the essential

requirements.

1.4. Where the type satisfies the provisions of these regulations, the notified

body must issue an EC type-examination certificate to the applicant. The certificate

must contain the conclusions of the examination, the conditions, if any, for its validity

and the necessary data for identification of the approved type and, if relevant,

descriptions of its functioning. Relevant technical elements such as drawings and

diagrams must be annexed to the certificate.

1.5. The notified body must inform the other notified bodies forthwith of the

issuing of the EC type-examination certificate and any additions to the said type as

referred to in point 1.7. They may obtain a copy of the EC type-examination certificate

and#or its additions and on a reasoned request may obtain a copy of the Annexes to the

certificate and the reports on the examinations and tests carried out.

1.6. A notified body which refuses to issue or withdraws an EC type-examination

certificate must inform the Member State which notified it and the other notified bodies

accordingly, giving the reasons for its decision.

1.7. The applicant must keep the notified body that has issued the EC type-

examination certificate informed of all modifications to the approved type which might

affect conformity with the essential requirements.

Modifications to the approved type must receive additional approval from the

notified body that issued the EC type-examination certificate where such changes affect

conformity with the essential requirements or the prescribed conditions for use of the

appliance. This additional approval is to be given in the form of an addition to the

original EC type-examination certificate.

2. EC DECLARATION OF CONFORMITY TO TYPE

2.1. The EC declaration of conformity to type is that part of the procedure

whereby the manufacturer declares that the appliances concerned are in conformity

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

requirements of these regulations which apply to them. The manufacturer or his

authorized representative established within the Community shall affix the CE marking

on each appliance and draw up a written certificate of conformity. The declaration of

conformity may cover one or more appliances and must be kept by the manufacturer.

The CE marking must be followed by the identification number of the notified body

responsible for the random checks set out in point 2.3.

2.2. The manufacturer must take all necessary measures to ensure that the

manufacturing process, including final product inspection and testing, results in

homogeneity of production and conformity of the appliances with the type as described

in the EC type-examination certificate and with the requirements of these regulations

which apply to them. A notified body, chosen by the manufacturer, must carry out

random checks on the appliances as set out in point 2.3.

2.3. On-site checks of appliances must be undertaken at random by the notified

body at intervals of one year or less. An adequate number of appliances must be

examined and appropriate tests as set out in the applicable standards referred to in

Article 5 of the Directive and regulation 5.3 of these regulations, or equivalent tests

must be carried out in order to ensure conformity with the corresponding essential

requirements of these regulations. The notified body shall in each case determine

whether these tests need to be carried out in full or in part. Where one or more appliances

are rejected, the notified body shall take the appropriate measures to prevent the

marketing thereof.

3. EC DECLARATION OF CONFORMITY TO TYPE (guarantee of

production quality)

3.1. The EC declaration of conformity to type (guarantee of production quality)

is the procedure whereby a manufacturer who fulfils the obligations in point 3.2 declares

that the appliances concerned are in conformity with the type as described in the EC

type-examination certificate and satisfy the essential requirements of these regulations

which applies to them. The manufacturer or his authorized representative must affix

the CE marking to each appliance and draw up a written declaration of conformity.

The CE marking must be followed by the identification number of the notified body

responsible for EC surveillance.

3.2. The manufacturer shall apply a quality system that ensures conformity of

the appliances with the type as described in the EC type-examination certificate and

with the essential requirements of these regulations which apply to them. The

manufacturer is subject to EC surveillance as specified in point 3.4.

3.3.

Quality system

3.3.1. The manufacturer must lodge an application for approval of his quality

system with a notified body of his choice for the appliances in question.

The application must include>

- the quality system documentation,

- an undertaking to carry out the obligations arising from the quality system

as approved,

- an undertaking to maintain the approved quality system to ensure its

continuing suitability and effectiveness,

- documentation relating to the approved type and a copy of the EC type-

examination certificate.

3.3.2. All the elements, requirements and provisions adopted by the manufacturer

must be documented in a systematic and logical manner in the form of measures,

procedures and written instructions. This quality system documentation must permit a

uniform interpretation of the quality programmes, plans, manuals and records. It shall

contain, in particular, an adequate description of>

- the quality objectives, the organizational structure and responsibilities of

management and of their powers with regard to appliance quality,

- the manufacturing processes, quality control and quality assurance

techniques 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 method of monitoring attainment of the required appliance quality and

the effective operation of the quality system.

3.3.3. The notified body shall examine and evaluate the quality system to

determine whether it satisfies the requirements referred to in point 3.3.2. It will presume

conformity with these requirements in respect of quality systems that implement the

corresponding harmonized standard.

It must notify its decision to the manufacturer and inform the other notified bodies

thereof. The notification to the manufacturer must contain the conclusions of the

examination, the name and address of the notified body and the reasoned assessment

decision in respect of the appliances concerned.

3.3.4. The manufacturer must keep the notified body that has approved the quality

system informed of any updating of the quality system in relation to changes brought

about by, for example, new technologies and quality concepts.

The notified body must examine the proposed modifications and decide whether

the modified quality system complies with the relevant provisions or whether reappraisal

is necessary. It must notify the manufacturer of its decision. The notification must

include the conclusions of the inspection and the reasoned assessment decision.

3.3.5. A notified body that withdraws approval of a quality system must so inform

the other notified bodies, giving the reasons for the decision.

3.4.

EC surveillance

3.4.1. The purpose of EC surveillance is to ensure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

3.4.2. The manufacturer must allow the notified body access for inspection

purposes to the place of manufacture, inspection, testing and storage and must provide

it with all necessary information, in particular>

- the quality system documentation,

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

data, reports on qualifications of the staff concerned, etc.

3.4.3. The notified body must carry out a check at least once every two years to

ensure that the manufacturer is maintaining and applying the approved quality system

and must supply a report of the check to the manufacturer.

3.4.4. Furthermore, the notified body may make unannounced visits to the

manufacturer. During these visits, the notified body may carry out tests on appliances

or have them carried out. It must supply the manufacturer with an inspection report

and, if appropriate, a test report.

3.4.5. The manufacturer may supply the notified body’s report on request.

4. EC DECLARATION OF TYPE CONFORMITY (guarantee of product

quality)

4.1. The EC declaration of type conformity (guarantee of product quality) is

that part of the procedure whereby a manufacturer who fulfils the obligations in point

4.2 declares that the appliances concerned are in conformity with the type as described

in the EC type-examination certificate and satisfy the essential requirements of these

regulations which apply to them. The manufacturer or his authorized representative

must affix the CE marking to each appliance and draw up a written declaration of

conformity. This declaration may cover one or more appliances and must be kept by

the manufacturer. The CE marking must be followed by the identification number of

the notified body responsible for EC surveillance.

4.2. The manufacturer shall apply an approved quality system for the final

inspection of the appliances and the tests, as specified in point 4.3, and is subject to EC

surveillance as specified in point 4.4.

4.3.

Quality system

4.3.1 Under this procedure, the manufacturer must lodge an application for

approval of his quality system with a notified body of his choice for the appliances in

question.

The application must include>

- the quality system documentation,

- an undertaking to carry out the obligations arising from the quality system

as approved,

- an undertaking to maintain the approved quality system to ensure its

continuing suitability and effectiveness,

- the documentation relating to the approved type and a copy of the EC type-

examination certificate.

4.3.2. As part of the quality system, each appliance must be examined and

appropriate tests as laid down in the applicable standard(s) referred to in Article 5 of

the Directive and regulation 5.3 of these regulations, or equivalent tests carried out to

check its conformity with the essential requirements relating to it in these regulations.

All the elements, requirements and provisions adopted by the manufacturer must

be documented in a systematic and logical manner in the form of measures, procedures

and written instructions. This quality system documentation must permit a uniform

interpretation of the quality programmes, plans, manuals and records.

The quality system documentation shall contain, in particular, an adequate

description of>

- the quality objectives, the organizational structure and responsibilities of

management and of their powers with regard to appliance quality,

- the checks and tests to be carried out after manufacture,

- the method of verifying the effective operation of the quality system.

4.3.3. The notified body shall examine and evaluate the quality system to

determine whether it satisfies the requirements referred to in point 4.3.2. It will presume

conformity with these requirements in respect of quality systems that implement the

corresponding harmonized standard. It must notify the manufacturer of its decision

and inform the other notified bodies thereof. The notification to the manufacturer must

contain the conclusions of the examination, the name and address of the notified body

and the reasoned assessment decision for the appliances concerned.

4.3.4. The manufacturer must keep the notified body which approved the quality

system informed of any adaptation of the quality system made necessary, e.g. by new

technology and quality concepts.

The notified body must examine the proposed changes and decide whether the

amended quality system satisfies the relevant provisions or whether a reassessment is

necessary. It must notify the manufacturer of its decision. The notification must contain

the conclusions of the inspection and the reasoned assessment decision.

4.3.5. A notified body which withdraws approval of a quality system must inform

the other notified bodies that it has done so and give reasons for its decision.

4.4.

EC surveillance

4.4.1. The purpose of EC surveillance is to ensure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

4.4.2. The manufacturer must allow the notified body access for inspection to the

place of inspection, testing and storage and must provide it with all necessary

information, in particular>

- the quality system documentation,

- the quality files such as inspection reports and test data, calibration data,

report on qualifications of the staff concerned, etc.

4.4.3. The notified body must carry out a check at least once every two years to

ensure that the manufacturer is maintaining and applying the approved quality system

and must supply a report on the check to the manufacturer.

4.4.4. Furthermore, the notified body may make unannounced visits to the

manufacturer. During these visits, the body may carry out tests on appliances or have

them carried out. It must supply the manufacturer with an inspection report and, if

appropriate, a test report.

4.4.5. The manufacturer may supply the notified body’s report on request.

5. EC VERIFICATION

5.1. EC verification is the procedure whereby the manufacturer or his authorized

representative ensures and declares that the appliances subject to the provisions of

point 3 are in conformity to the type as described in the EC type-examination certification

and satisfy the requirements of these regulations that apply to them.

5.2. The manufacturer or his authorized representative must take all measures

necessary in order that the manufacturing process ensures conformity of the appliances

to the type as described in the EC type-examination certification and to the requirements

of these regulations that apply to them. The manufacturer or his authorized representative

must affix the CE marking to each appliance and draw up a written declaration of

conformity. The declaration of conformity may cover one or more appliances and

must be kept by the manufacturer or his authorized representative.

5.3. The notified body must carry out the appropriate examinations and tests in

order to check the conformity of the appliance to the requirements of these regulations

by examination and testing of every appliance, as specified in point 5.4, or by

examination and testing of appliances on a statistical basis, as specified in point 5.5, at

the choice of the manufacturer.

5.4.

Verification by checking and testing of each appliance

5.4.1. All appliances must be individually examined and appropriate tests, as set

out in the relevant standard(s) referred to in Article 5 of the Directive and regulation

5.3 of these regulations, or equivalent tests, must be carried out in order to verify their

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

requirements of these regulations that apply to them.

5.4.2. The notified body must affix, or cause to be affixed, its identification number

on each appliance and draw up a written certificate of conformity relating to the tests

carried out. The certificate of conformity may cover one or more appliances.

5.4.3. The manufacturer or his authorized representative must ensure that he is

able to supply the notified body’s certificates of conformity on request.

5.5.

Statistical verification

5.5.1. Manufacturers must present the appliances manufactured in the form of

uniform batches and must take all necessary measures in order that the manufacturing

process ensures the uniformity of each batch produced.

5.5.2. Statistical control is as follows>

Appliances are subject to statistical control by attributes. They should be grouped

into identifiable batches consisting of units of a single model manufactured under the

same conditions. A batch is examined at random intervals. The appliances constituting

a sample are examined individually and appropriate tests, as laid down in the respective

standard(s) referred to in Article 5 of the Directive and regulation 5.3 of these regulations,

or equivalent tests are carried out to determine whether the batch is to be accepted or

rejected.

A sampling system with the following characteristics is applied>

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

with a non-conformity percentage of between 0.5 and 1.5 %,

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

percentage of non-conformity of between 5 and 10 %.

5.5.3. Where batches are accepted, the notified body must affix, or cause to be

affixed, its identification number to each appliance and draw up a written certificate of

conformity relating to the tests carried out. All appliances in the batch may be placed

on the market except for those products from the sample which were found not to be in

conformity.

Where a batch is rejected, the notified body must take appropriate measures to

prevent the placing on the market of that batch. In the event of frequent rejection of

batches the notified body may suspend the statistical verification. The manufacturer

may, under the responsibility of the notified body, affix the latter’s identification number

during the manufacturing process.

5.5.4. The manufacturer or his authorized representative must ensure that he is

able to supply the notified body’s certificates of conformity on request.

6. EC UNIT VERIFICATION

6.1. EC unit verification is the procedure whereby the manufacturer or his

authorized representative ensures and declares that the appliance concerned, which

has been issued with the certificate referred to in point 2, conforms to the requirements

of these regulations that apply to it. The manufacturer or his authorized representative

must affix the CE marking to the appliance and draw up a written declaration of

conformity which he must keep.

6.2. The notified body must examine the appliance and carry out the appropriate

tests, taking account of the design documentation in order to ensure its conformity

with the essential requirements of these regulations.

The notified body must affix, or cause to be affixed, its identification number to

the approved appliance and must draw up a written certificate of conformity concerning

the tests carried out.

6.3. The aim of the technical documentation relating to the design of the

instrument, as referred to in Annex IV of the Directive, which is set out in Schedule IV

to these regulations, is to enable conformity to the requirements of these regulations to

be assessed and the design, manufacture and operation of the appliance to be understood.

The design documentation referred to in Annex IV of the Directive, which is set

out in Schedule IV hereto must be made available to the notified body.

6.4. If deemed necessary by the notified body, the examinations and tests may

be carried out after installation of the appliance.

6.5. The manufacturer or his authorized representative must ensure that he is

able to supply the notified body’s certificates of conformity on request.

Schedule III

Annex III of the Directive

CE CONFORMITY MARKING AND INSCRIPTIONS

The CE conformity marking consists of the initials “CE” as shown below>

The CE marking must be followed by the identification number of the notified

body involved in the production control phase.

The appliance or its data plate must bear the CE marking together with the

following inscriptions>

- the manufacturer’s name or identification symbol,

- the trade name of the appliance,

- the type of electrical supply used, if applicable,

- the appliance category,

- the last two digits of the year in which the CE marking was affixed.

Information needed for installation purposes may be added according to the nature

of the appliance.

3 If the CE marking is reduced or enlarged the proportions given in the above

graduated drawing must be respected.

The various components of the CE marking must have substantially the same

vertical dimension, which may not be less than 5mm.

Schedule IV

Annex IV of the Directive

DESIGN DOCUMENTATION

The design documentation must contain the following information, in so far as is

required by the notified body for assessment>

- a general description of the appliance,

- conceptual designs and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of the above,

including the operation of the appliances,

- a list of the standards referred to in Article 5 of the Directive and regulation

5.3 of these regulations, applied in full or in part, and descriptions of the solutions

adopted to meet the essential requirements where the standards referred to in

Article 5 of the Directive and regulation 5.3 of these regulations have not been

applied,

- test reports,

- manuals for installation and use.

Where appropriate, the design documentation must contain the following elements>

- attestations relating to the equipment incorporated in the appliance,

- attestations and certificates relating to the methods of manufacture and#or

inspection and#or monitoring of the appliance,

- any other document making it possible for the notified body to improve its

assessment.

Schedule V

Annex V of the Directive

MINIMUM CRITERIA FOR ASSESSMENT OF NOTIFIED BODIES

The notified bodies designated by the Member States must fulfil the following

minimum conditions>

- availability of personnel and of the necessary means and equipment,

- technical competence and professional integrity of personnel,

- independence in carrying out tests, preparing reports, issuing certificates

and performing the surveillance provided for in these regulations, of management

and technical staff in relation to all circles, groups or persons directly or indirectly

involved in the field of the appliances,

- maintenance of professional secrecy by staff,

- possession of civil liability insurance unless that liability is covered by the

State under national law.

Fulfilment of the conditions in the first two indents must be periodically verified

by the competent authorities of the Member States or by bodies designated by the

Member States.