Sch 1A para 97 Design examination
(1) The manufacturer shall lodge an application for the examination of the design of each item of pressure equipment, or assembly, not covered by a previous design examination with the approved body referred to in paragraph 96(1). (2) The application shall make it possible to understand the design, manufacture and operation of the pressure equipment, or assembly, and to assess the conformity with the requirements of these Regulations that apply to it. (3) The application shall include— (a) the name and address of the manufacturer; (b) the technical documentation for one model of each type of pressure equipment, or assembly, intended to be manufactured which shall, wherever applicable, contain— (i) a general description of the pressure equipment or assembly; (ii) conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits all other relevant parts, to component level; (iii) descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment or assembly; (iv) a list of the designated standards, applied in part or in full, and descriptions of the solutions adopted to meet the essential safety requirements of these Regulations where those designated standards have not been applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied; (v) results of design calculations made, examinations carried out and the results of any other relevant calculation or examination; (vi) test reports; (c) a written declaration that the same application has not been lodged with any other approved body; and (d) the supporting evidence for the adequacy of the technical design. The supporting evidence shall mention any documents that have been used, in particular where the relevant designated standards have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory on their behalf and under their responsibility. (4) Where the design meets the requirements of these Regulations the approved body shall issue a design examination certificate. (5) The design examination certificate— (a) must include— (i) the name and address of the manufacturer; (ii) the conclusions of the examination; (iii) the conditions (if any) for the validity of the certificate; and (iv) data necessary for identification of the approved design; (b) may have one or more annexes attached; (c) shall contain all relevant information to allow the conformity of manufactured products with the examined design to be evaluated, and to allow for in-service control, where applicable. (6) Where the design does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving details for its refusal. (7) The approved body shall keep itself appraised of any changes in the generally acknowledged state of the art which indicates that the approved design may no longer comply with the applicable requirements of these Regulations, and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly. (8) The manufacturer shall inform the approved body that issued the design examination certificate of all modifications to the approved design that may affect the conformity of the pressure equipment, or assembly, with the essential safety requirements of these Regulations or the conditions for validity of the certificate. Such modifications shall require additional approval, from the approved body that issued the design examination certificate, in the form of an addition to the original design examination certificate. (9) Each approved body shall inform the Secretary of State of the design examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of certificates and any additions thereto refused, suspended or otherwise restricted. (10) Each approved body shall inform the other approved bodies concerning the design examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, concerning the certificates and additions thereto that it has issued. (11) Other approved bodies may, on request, obtain a copy of the design examination certificate and additions thereto. (12) The approved body shall keep a copy of the design 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 the certificate. (13) The manufacturer shall keep a copy of the design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.