Fittings shall be so designed and constructed as to fulfil correctly their intended purpose when incorporated into an appliance or assembled to constitute an appliance.
eliminate or reduce risks as far as possible (inherently safe design and construction);
take the necessary protection measures in relation to risks that cannot be eliminated;
inform users of the residual risks due to any shortcomings of the protection measures adopted and indicate whether any particular precautions are required.
be accompanied by instructions for installation intended for the installer;
be accompanied by instructions for use and servicing, intended for the user;
bear appropriate warning notices, which shall also appear on the packaging.
The instructions for installation intended for the installer shall include also information on the technical specifications of the interface between the appliance and its installation environment allowing its correct connection to the gas supply network, the supply of auxiliary energy, the combustion air supply and the flue gas evacuation system.
The manufacturers shall note in the instructions where additional care is needed or where it would be advisable that any of the above work be carried out by a professional. This shall be without prejudice to national requirements to that effect.
The manufacturer of the appliance shall include in the instructions accompanying the appliance all necessary information for adjustment, operation and maintenance of the fittings as part of the finished appliance, as appropriate.
Materials for appliances or fittings shall be appropriate for their intended purpose and shall withstand the mechanical, chemical and thermal conditions to which they will foreseeably be subjected.
The obligations arising for appliances from the essential requirements set out in this point apply also to fittings, as far as relevant.
Appliances shall be so designed and constructed that, when normally used, ignition and re-ignition is smooth and cross-lighting is assured.
Appliances shall be so designed and constructed as to ensure rational use of energy, reflecting the state of the art and taking into account safety aspects.
Without prejudice to Regulations (EC) No 1935/2004(4) and (EU) No 305/2011(5) of the European Parliament and of the Council, materials and parts used in the construction of an appliance which may come into contact with food or water intended for human consumption as defined in Article 2 of Council Directive 98/83/EC(6), shall not impair quality of the food or water.
| (a) | combustion reference temperature: | 15 °C; |
| (b) | volume measurement reference temperature: | 15 °C; |
| (c) | volume measurement reference pressure: | 1 013,25 mbar. |
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
the technical documentation. The technical documentation shall make it possible to assess the appliance's or fitting's conformity with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the appliance or the fitting. The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the appliance or the fitting;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the appliance or the fitting;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
results of design calculations made, examinations carried out, etc.;
test reports;
instructions for installation and use of the appliance;
the EU declaration of conformity of the fitting containing the instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance;
the specimens representative of the production envisaged. The notified body may request further specimens where needed for carrying out the test programme;
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
the EU type-examination certificate and the EU declaration of conformity relating to the fittings incorporated into the appliance;
attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance or the fitting;
any other document making it possible for the notified body to improve its assessment.
For the appliance or the fitting:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the appliance or the fitting.
For the specimen(s):
verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Regulation;
agree with the manufacturer on a location where the examinations and tests will be carried out.
The EU type-examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured appliances or fittings with the examined type to be evaluated and to allow for in-service control. It shall also indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved type.
The certificate shall have a maximum validity period of ten years from the date of its issue.
Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU type-examination certificate of all modifications to the approved type that may affect the conformity of the appliance or the fitting with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.
Each notified body shall inform the other notified bodies concerning the EU type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU type-examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the type described in the EU type-examination certificate and with the requirements of this Regulation that apply to them.
A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at intervals of one year or less, in order to verify the quality of the internal checks on the appliance or the fitting, taking into account, inter alia, the technological complexity of the appliances or the fittings and the quantity of production. An adequate sample of the final appliances or fittings taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to check the conformity of the appliance or the fitting with the relevant requirements of this Regulation. Where a sample does not conform to the acceptable quality level, the notified body shall take appropriate measures.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the appliance or the fitting performs within acceptable limits, with a view to ensuring conformity of the appliance or the fitting.
The manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
The manufacturer's obligations set out in point 2.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the appliances or fittings concerned as specified in point 3.3, and shall be subject to surveillance as specified in point 3.4.
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 as well;
a written declaration that the same application has not been lodged with any other notified body;
all relevant information for the appliance or the fitting approved under module B;
the documentation concerning the quality system;
the technical documentation of the approved type and a copy of the EU type-examination certificate.
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. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
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 on the personnel concerned, etc.;
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and the product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.3.1(e), to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the appliance or the fitting with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
the quality system documentation;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
the documentation referred to in point 3.3.1;
the information relating to the change referred to in point 3.3.5, as approved;
the decisions and reports of the notified body referred to in points 3.3.5, 3.4.3 and 3.4.4.
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
The manufacturer's obligations set out in points 3.3.1, 3.3.5, 3.5 and 3.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall operate an approved quality system for final product inspection and testing of the appliances or fittings concerned as specified in point 4.3 and shall be subject to surveillance as specified in point 4.4.
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 as well;
a written declaration that the same application has not been lodged with any other notified body;
all relevant information for the product category envisaged;
the documentation concerning the quality system; and
the technical documentation of the approved type and a copy of the EU type-examination certificate.
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. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain 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 on the personnel concerned, etc.;
the means of monitoring the effective operation of the quality system.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 4.3.1(e), in order to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the appliance or the fitting with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 4.3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
the quality system documentation;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
the documentation referred to in point 4.3.1;
the information relating to the change referred to in point 4.3.5, as approved;
the decisions and reports of the notified body referred to in points 4.3.5, 4.4.3 and 4.4.4.
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
The manufacturer's obligations set out in points 4.3.1, 4.3.5, 4.5 and 4.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the approved type described in the EU type-examination certificate and with the requirements of this Regulation that apply to them.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the appliances or fittings with the approved type described in the EU type-examination certificate and with the appropriate requirements of this Regulation.
The examinations and tests to check the conformity of the appliances or fittings with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every appliance or fitting as specified in point 5.4 or by examination and testing of the appliances or fittings on a statistical basis as specified in point 5.5.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the appliance or the fitting has been placed on the market.
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 non-conformity percentage of between 5 % and 10 %.
The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved appliance or fitting, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
If the notified body referred to in point 5.3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the appliance or the fitting.
The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in points 5.2 and 5.5.1.
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 6.4. The technical documentation shall make it possible to assess the appliance's or fitting's conformity with the applicable requirements of this Regulation, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the appliance or the fitting.
a general description of the appliance or the fitting;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the appliance or the fitting;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
results of design calculations made, examinations carried out, etc.;
test reports;
instructions for installation and use, for appliances;
instructions for incorporation into an appliance or for assembly, for fittings.
the EU type-examination certificate and the EU declaration of conformity relating to the fittings incorporated into the appliance;
attestations and certificates relating to the methods of manufacture and inspection and monitoring of the appliance or the fitting;
any other document making it possible for the notified body to improve its assessment.
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the appliance or the fitting has been placed on the market.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the applicable requirements of this Regulation.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the appliances or fittings with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.
If deemed necessary by the notified body, the examinations and tests may be carried out after the incorporation of the fitting, the assembly or the installation of the appliance.
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 the approved appliances or fittings, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
The manufacturer's obligations set out in points 6.2 and 6.5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
the manufacturer's name, registered trade name or registered trade mark;
the appliance type, batch or serial number of the appliance or other element allowing its identification;
the type of electrical supply used, where applicable;
the appliance category marking;
the nominal supply pressure for the appliance;
the necessary information to ensure correct and safe installation, according to the nature of the appliance.
Signed for and on behalf of: …
(place and date of issue):
(name, function) (signature):
| Directive 2009/142/EC | This Regulation |
|---|---|
| Article 1(1) first subparagraph | Article 1(1) |
| Article 1(1) second subparagraph | Article 1(3)(a) |
| — | Article 1(3)(b) and (c) |
| — | Article 1(4) to (6) |
| Article 1(2) | Article 2, points 1, 2 and 6 |
| Article 1(3) | Article 1(2) |
| — | Article 2, points 3, 4, 5, 7 to 31 |
| Article 2(1) | Article 3(1) |
| — | Article 3(2) and (3) |
| Article 2(2) | Article 4(1) and (4) |
| — | Article 4(2) and (3) |
| Article 3 | Article 5 |
| Article 4 | Article 6(1) and (2) |
| — | Article 6(3) |
| — | Article 7 |
| — | Article 8 |
| — | Article 9 |
| — | Article 10 |
| — | Article 11 |
| — | Article 12 |
| — | Article 13 |
| Article 5(1)(a) | — |
| Article 5(1)(b) | — |
| Article 5(2) | — |
| Article 6 | — |
| Article 7 | — |
| Article 8(1), (2) and (4) | Article 14(1) to (3) |
| Article 8(3) and (5) | — |
| Article 8(6) | Article 14(4) |
| — | Article 15 |
| — | Article 16 |
| Article 9 | — |
| Article 10 | — |
| — | Article 17 |
| Article 11 | — |
| Article 12 | — |
| — | Article 18 |
| — | Article 19 |
| — | Article 20 |
| — | Article 21 |
| — | Article 22 |
| — | Article 23 |
| — | Article 24 |
| — | Article 25 |
| — | Article 26 |
| — | Article 27 |
| — | Article 28 |
| — | Article 29 |
| — | Article 30 |
| — | Article 31 |
| — | Article 32 |
| — | Article 33 |
| — | Article 34 |
| — | Article 35 |
| — | Article 36 |
| — | Article 37 |
| — | Article 38 |
| — | Article 39 |
| — | Article 40 |
| — | Article 41 |
| — | Article 42 |
| — | Article 43 |
| — | Article 44 |
| Article 13 | — |
| Article 14 | — |
| Article 15 | — |
| Article 16 | — |
| — | Article 45 |
| — | Article 46 |
| Annex I | Annex I |
| — | Annex II |
| Annex II | Annex III |
| Annex III | Annex IV |
| Annex IV | — |
| Annex V | — |
| Annex VI | — |
| — | Annex V |
| — | Annex VI |
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).
Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79).
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5).
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).
It is optional for the manufacturer to assign a number to the declaration of conformity.