B (design) + F
Module B (design) is always followed by other modules by which the conformity of the pressure equipment to the approved EU-type is demonstrated. A notified body examines design of a type and verifies and attests that it meets the requirements of the PED that apply to it by issuing an EU-type examination certificate.
Module F – The manufacturer ensures compliance of the manufactured pressure equipments to approved EU-type. The notified body carries out pressure equipment examinations (testing of every pressure equipment) in order to control product conformity to EU-type.
Module F is like C2 but the notified body carries out more systematic product checks.
This module combination is suitable for pressure equipments categories I, II, and III.
Module B (Design)
EU-TYPE EXAMINATION – Design type
1. EU-type examination – design type is the part of a conformity assessment procedure in which a notified body examines the technical design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets the requirements of this Directive.
2. The EU-type examination – design type shall consist of an assessment of the adequacy of the technical design of the pressure equipment through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen.
The experimental design method provided for in point 2.2.4 of Annex I shall not be used in the context of this module.
3. The manufacturer shall lodge an application for EU-type examination — design type with a single notified body of his choice.
The application shall include:
- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address 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 conformity of the pressure equipment with the applicable requirements of the Directive 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 pressure equipment. The technical documentation shall contain, wherever applicable, at least the following elements:
- a general description of the pressure equipment,
- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
- descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,
- a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been 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.,
- information regarding the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,
- 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. This supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.
The application may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.
4. The notified body shall:
4.1 examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product.
In particular, the notified body shall:
- assess the materials where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials,
- approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with point 3.1.2 of Annex I.
4.2 carry out appropriate examinations to check whether where the manufacturer has chosen to apply the solutions in the relevant harmonised standards these have been applied correctly.
4.3 carry out appropriate examinations to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer meet the corresponding essential safety requirements of this Directive.
5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
6. Where the design meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate — design type to the manufacturer. Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved design.
A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment with the examined design to be evaluated and to allow for in-service control.
Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate — design type and shall inform the applicant accordingly, giving detailed reasons for its refusal.
7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate — design type of all modifications to the approved design that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive 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 — design type.
8. Each notified body shall inform its notifying authorities concerning the EU-type examination certificates — design type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates — design type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the 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 — design type 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 — design type, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
9. The manufacturer shall keep a copy of the EU-type examination certificate — design type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
Module F
CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT VERIFICATION
1. Conformity to type based on pressure equipment verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned, which has been subject to the provisions of point 3, is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive which apply to it.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of this Directive which apply to them.
3. Verification
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to check the conformity of the pressure equipment with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
The examinations and tests to check the conformity of the pressure equipment with the appropriate requirements shall be carried out by examination and testing of every product as specified in point 4.
4. Verification of conformity by examination and testing of every item of pressure equipment
4.1 All pressure equipment shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) or equivalent tests shall be carried out in order to verify conformity with the approved type and described in the EU-type examination certificate and with the appropriate requirements of this Directive. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
In particular, the notified body shall:
- verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with points 3.1.2 and 3.1.3 of Annex I,
- verify the certificate issued by the materials manufacturer in accordance with point 4.3 of Annex I,
- carry out or have carried out the final inspection and proof test referred to in point 3.2 of Annex I and examine the safety devices, if applicable.
4.2 The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number or have it affixed under its responsibility to each approved item of pressure equipment.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the pressure equipment has been placed on the market.
5. CE marking and EU declaration of conformity
5.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual item of pressure equipment that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
5.2 The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities, for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the pressure equipment.
6. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the pressure equipment during the manufacturing process.
7. Authorised representative
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 point 2.
