GUIDE PPE - Cyprus Organization for the Promotion of Quality

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Guide on PPE Directive EuropeAid /114385/D/SV/CY • PPE providing only limited protection against chemical attack or against ionising radiation; • emergency equipment for use in high-temperature environments, the effects of which are comparable to those of an air temperature of 100 °C or more and which may or may not be characterised by the presence of infrared radiation, flames or the projection of large amounts of molten material; • emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air temperature of - 50 °C or less; • PPE to protect against falls from a height; • PPE against electrical risks and dangerous voltages or used as insulation in high-tension work. All other PPE belong to category II. Thus no list of Category II PPE is given in the directive. The Commission has published a Guide to categorize PPE, which will be updated in the light of experience of application of the directive. http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/categorizationguide.pdf TECHNICAL DOCUMENTATION Before placing a PPE model on the market, the manufacturer must assemble a technical documentation the content of which is set out in Annex III of the directive. The documentation must comprise all relevant data on the means used by the manufacturer to ensure that a PPE complies with the EHSRs applicable. For category II and III PPE, the documentation must comprise in particular: 1. The manufacturer’s technical file consisting of: • overall and detailed plans of the PPE accompanied, when appropriate, by calculation notes and the results of prototype tests in so far as necessary for the verification of compliance with the EHSRs; • an exhaustive list of the EHSRs and of the harmonized standards or other technical specifications taken into account in the design of the model; 2. A description of the control and test facilities to be used in the manufacturer's plant to check compliance of production PPE with the harmonized standards or other technical specifications and to maintain quality level; 3. A copy of the information supplied with the equipment shall be supplied to the notified body with the technical file.
Guide on PPE Directive EuropeAid /114385/D/SV/CY NOTIFIED BODIES For most types of PPE, with the exception of a limited list of PPE to cover minimal risks, the directive requires third party conformity evaluation prior to placing on the market. Some types of PPE for very serious risks are also submitted to evaluation of the conformity of production. Member States are responsible for designating the bodies able to carry out these evaluation procedures, and for notifying the bodies thus approved to the European Commission. Annex V of the directive lays down the minimal criteria, which such a body must meet: • availability of the necessary personnel and equipment; • competence and integrity of personnel; • independence from parties with a vested interest in the manufacture and sale of PPE; • maintenance of professional secrecy; • subscription to civil liability insurance. Bodies complying with the requirements of the appropriate standards of the EN ISO 17000 / EN 45000 series are presumed to comply with these minimum criteria. It is recommended that the testing laboratories should have accreditation according to the standard EN ISO 17025 Most Member States designate bodies, which have been accredited by the national accreditation system, according to one or other of these standards. A body must be notified for one or more specific procedures: EC type-examination according to Article 10 of the directive, or one of the EC quality control systems according to Article 11. Member States are free to take into account further criteria, such as the particular experience of the body in the field of the PPE concerned, participation of the body in the work of co-ordination between Notified Bodies, or participation in standardization work. The notifying authority is also responsible for checking periodically that the bodies that they have notified remain in compliance with the criteria. National authorities are free to choose the most effective and appropriate means of carrying out these checks. Regular reporting on activity to the notifying authority seems indispensable. Some Member States delegate entirely the task of checking Notified Bodies to their national accreditation bodies. In other cases, the public authorities themselves carry out regular audits of the bodies they have notified. In several Member States a combination of the two approaches is used. The list of Notified bodies is given in: http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/nb.htm As NB fulfil tasks delegated to them by public authorities, they have a duty to take part in Co-ordination activities organised by the Commission. Objectives of the Co-ordination of Notified Bodies are as follows: • to share experience on practical application of the conformity assessment procedures, with the aim of reaching common understanding of the requirements of the directive; • to identify points of difficulty and propose agreed solutions on the basis of consensus; • to raise matters of interpretation of the directive with the Commission and Member States and seek guidance;
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