Why is the technical file important?
In EU-type examination (Module B), the notified body first assesses the product's conformity with the essential requirements of the Regulation on the basis of the technical file. The file must cover the design, manufacture and operation of the appliance and include an adequate analysis of the risks. An incomplete file delays the start of the assessment and the planning of tests.
Content of the application file
Under the İNTEGRA96 Gas Appliances Certification Programme, the application includes at least the following:
- The name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the representative.
- A written declaration that no application has been lodged with another notified body for the same product.
- A technical file, including a risk analysis, that enables the conformity of the appliance or fitting with the applicable requirements of the Regulation to be assessed: design, manufacturing and operating documentation.
- A sample or samples representative of production for the test programme.
Supporting evidence
If harmonised standards have not been applied in full, evidence showing how the technical solution adopted meets the essential requirements must be added to the file. Where applicable, the file also includes the EU-type examination certificate and EU declaration of conformity of the fittings incorporated in the appliance, together with approvals and certificates relating to production, inspection or monitoring methods.
Test results obtained in the manufacturer's own laboratory may be submitted as supporting evidence; the validity of these results is assessed separately with regard to the competence of the laboratory and the suitability of the method.
Common omissions
- No list of the standards applied, or no indication of whether the standards have been applied in full or in part.
- A risk analysis that is merely a generic template and does not address hazards specific to the appliance.
- Gas category, supply pressure and heat input data that do not match between the file and the rating plate.
- Instructions for use and installation not provided in the language of the target market.
Pre-application checklist
- Product name, type/model and list of variants
- Harmonised standards applied and whether they have been applied in full
- Design drawings, circuit diagrams, bill of materials
- Risk analysis and technical solutions
- Instructions for use, installation and maintenance; sample rating plate
- Certificates of the fittings used