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(j) a description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications (i) reports on the tests carried out to verify the conformity of the PPE with the applicable essential health and safety requirements and, where appropriate, to establish the relevant protection class (h) the results of the design calculations, inspections and examinations carried out to verify the conformity of the PPE with the applicable essential health and safety requirements (g) where harmonised standards have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements Issued 07 April 2016 of 3 In the event of partial application of harmonised standards, the documentation shall specify the parts which have been applied (f) the references of the harmonised standards referred to in Article 14 that have been applied for the design and manufacture of the PPE. (e) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (d) and of the operation of the PPE (d) design and manufacturing drawings and schemes of the PPE and of its components, sub-assemblies and circuits (c) a list of the essential health and safety requirements that are applicable to the PPE (b) an assessment of the risks against which the PPE is intended to protect (a) a complete description of the PPE and of its intended use The requirements of the technical file (Annex III) have been re-specified: Our records show that many clients have Article 10 certificates that go back over very many years and it is therefore important that these products are reviewed and SGS is informed of those that are no longer required. Otherwise a revision of the technical file will be required. a revised harmonised standard issued? If the answers to the above are both “NO” then review will be simple (low cost) and a new certificate issued. Has the there been a change in the state of the art e.g. Has the product been modified which could affect the conformity of the product to applicable essential health and safety requirements? SGS will advise you of when this is due and will ask you if the following apply: These will have a validity of five years.Ģ016/425 requires the manufacturer to submit an application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate. This document provides a summary of the key changes which will apply.ĭirective 89/686/EEC is repealed with effect from 21 April 2018.ĮC type-examination certificates (Article 10) approved 89/686/EEC remain valid until 21 April 2023 unless they expire before that date.įor Notified Bodies (NBs) such as SGS United Kingdom Limited (SGS) then there are aspects of the regulation that come in to force on the 21 October 2016.ĮC Type-examination certificates issued under Article 10 of 89/686/EEC are renamed as EU type-examination certificates and will be issued under Module B in Annex V. This regulation repeals the PPE Directive 89/686/EEC and replaces it. 100/16 On the 9 March 2016 Regulation (EU) 2016/425 was approved and published in the Official Journal of the European Union on the. SAFE GUARDS | Personal Protective Equipment NO.