GUIDE PPE - Cyprus Organization for the Promotion of Quality

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Guide on PPE Directive EuropeAid /114385/D/SV/CY • to discuss working documents submitted by the Commission and Member States and express the views of Notified Bodies on the issues raised. The European Co-ordination of Notified Bodies for PPE has two basic structures: The Horizontal Committee of Notified Bodies for PPE deals with questions of general interest and Vertical Groups of NB for PPE are dealing with questions specific to certain PPE types The following Vertical Groups are in operation: VG 1 VG 2 VG 3 VG 4 VG 5 VG 6 VG 8 VG 9 VG 10 VG 11 Head protection Respiratory protection Eye and face protection Hearing protection Protective clothing, hand and arm protection Protection against knife cut Lifejackets Motorcycle rider's protective clothing and protectors for sports Foot and leg protection Protection against falls from a height In addition, an ad hoc Group of the Horizontal Group deals with questions arising from the quality control procedures defined by Articles 11 A and B of the directive. An important tool of the Co-ordination of Notified Bodies in the field of PPE is the drafting of Technical coordination sheets. If a NB, a Vertical group or the Horizontal Committee has a question of technical or horizontal nature, they can draft a Proposal for Enquiry. This proposal contains a short description of the problem and a proposed solution. If the question only concerns one Vertical Group, this group can approve the proposed solution and turn it into a Recommendation for Use, which is a recommendation for all the Notified Bodies, active in this field aiming at reaching uniform treatment of the manufacturers throughout the Community. Most of the recommendations of a vertical nature concern questions arising during the testing and certification process: either no harmonized standards are available, or the harmonized standards are not sufficient or standards for test procedures are not precise enough. Recommendations for Use are thus in principle only temporary solution of problems arising from the use of standards. The aim must be to improve the standards during the revision. If the question is of a horizontal nature or concerns interpretation of the directive, the Proposal for Enquiry is first dealt with by the Advisory Panel, then transferred to the Horizontal Committee, where a decision is taken, either to reject the proposal, or to pass on the enquiry to the Commission for discussion by the Standing Committee. All Recommendations for Use of a horizontal nature are given to the Commission for information, and those dealing with the interpretation of the PPE Directive, are submitted for approval
Guide on PPE Directive EuropeAid /114385/D/SV/CY to the Standing Committee. If the Recommendation for Use is of a general, horizontal nature, all Notified Bodies are informed. If the Recommendation for Use is only of relevance for a certain area of PPE, only those Notified Bodies who are active in this field will be informed. EC TYPE-EXAMINATION Prior to the (series) production of category II or III PPE, the manufacturer or his authorised representative established in the Community shall submit a model for EC type-examination. EC type-examination is the procedure whereby a NB establishes and certifies that the PPE model in question satisfies the relevant provisions of the PPE Directive. Application for EC type-examination shall be made by the manufacturer or his authorised representative to a single approved inspection body in respect of the model in question. The application shall comprise: • The name and address of the manufacturer or his authorised representative and of the PPE production plant in question; • The manufacturer's technical file; • The information supplied by the manufacturer. It shall be accompanied by the appropriate number of specimens of the model to be approved. The number of samples needed determined by the NB, but indication is normally given in the relevant harmonized standard. The application of harmonized standards that give a presumption of conformity remains voluntary. If the manufacturer has designed the product according to a harmonized standard, the NB shall conduct the EC type-examination first examining the manufacturer's technical file to establish its suitability with respect to the harmonized standards. If a manufacturer has not applied, or has only partly applied, the harmonized standards, or when there are no such standards, the NB must check the suitability of the technical specifications used by the manufacturer with respect to the EHSRs. If the manufacturer partly applies a harmonized standard or if the relevant harmonized standard does not cover all the EHSRs applicable to the product, the presumption of conformity exists only with regard to the EHSRs covered by the standard. The NB shall make the necessary tests to verify that PPE has been produced in accordance with the manufacturer's technical file and can be used in complete safety for its intended purpose in foreseeable conditions of use. Most PPE is tested according to the methods described in the harmonized standards. EC TYPE-EXAMINATION CERTIFICATE If the model satisfies the relevant requirements, the NB shall draw up an EC type-examination certificate. This certificate shall reproduce the findings of the examination, indicate any conditions attaching to its issue and incorporate the descriptions and drawings necessary for the identification of the approved model. If the PPE does not fulfil, the requirements of the directive, the NB shall refuse to issue an EC typeexamination certificate. In this case, the NB shall inform the other Notified Bodies. However in practice the testing is usually discontinued when negative results are found, and the manufacturer has the possibility to make changes to the design of the PPE.
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GUIDE PPE - Cyprus Organization for the Promotion of Quality

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