Testing and Certification of Personal Protective Equipment in Europe

Transcription

1 Testing and Certification of Personal Protective Equipment in Europe Dipl.-Inform. Hendrik Beier Head of Certification Department Notified Body 0516 Sächsisches Textilforschungsinstitut e.v. (STFI) European Home market Since 1 st January 1993 The foremost aim of the European home market is the reduction of trade barriers to realise a free movement of goods 1

2 Reduction of trade barriers what is to be done...? What are prerequisites for that...? homogeneous safety requirements for the products harmonized European, instead of national regulations mutual recognition of the conformity assessment results homogeneous standards for the marking of the products homogeneous requirements to the authorities carrying out the conformity assessment How can the conformity be demonstrated...? CE - marking as Passport for free exchange of goods (CE = Communauté Européenne = European Community) The CE sign is not primary a sign for quality, it is a conformity label to guarantee the correspondence to the harmonized requirements. The product can be marked with this sign if all obligatory product requirements are fulfilled. 2

3 What does CE marking mean...? Is it compulsory...? By affixing the CE mark on a relevant product (i.e. protective clothing) the manufacturer gives a graphical declaration of conformity with the relevant health and safety requirements of the related Directive (i.e. PPE Directive). The CE marking is compulsory for all kind of PPE covered by Directive 89/686/EEC. CE Certification / General situation 1 st July 1995 Elevators for Personal Use Construction Products Radio and Telecommunications Equipment Machinery Medical Devices Low Voltage Electrical Apparatus Toys Pressure Equipment Personal Protective Equipment... 95/16/EEC 89/106/EEC 1999/5/EEC 89/37/EEC 93/42/EEC 73/23/EEC 88/378/EEC 97/23/EC 89/686/EEC 3

4 General Directive for industrial safety 89/391/EEC Industrial safety law PPE Directive 89/656/EEC for end users Regulation for safety and health at work PPE Directive 89/686/EEC for manufacturer 8. ordinance to Equipment and product safety Act EC Commission Block diagram for the EC Type examination Notification National office for accreditation (ZLS) Notification application Application Test report Notified Body Accreditation Test order application Certificate accredited test laboratory European home market CE sign manufacturer PPE Product Conformity evidence CE sign 4

5 Conditions to be fulfilled by the Bodies of which notification has been given: The bodies designated by the Member States must fulfil the following minimum conditions: 1. availability of personnel and of the necessary means and equipment 2. technical competence and professional integrity of personnel 3. independence, in carrying out the tests, preparing the reports, issuing the certificates and performing the surveillance provided for in the Directive, of staff and technical personnel in relation to all circles, groups or persons directly or indirectly concerned with PPE 4. maintenance of professional secrecy by personnel 5. subscription of a civil liability insurance Certification of PPC in Germany - Notified Body 0516 CE Marking Required for all Kinds of PPE 5

6 Certification of PPC in Germany - Notified Body 0516 Certification Department for personal protective clothing according to EC Directive 89/686/EEC and in compliance with ISO and EN competent consultancy for companies in all steps of testing and certification - active work in national and international committees for standardization and knowledge transfer - immediate use of newly gained knowledge for the assessment of PPC and ongoing improvement of the test equipment 6

7 Testing & Certification for more than 400 clients in 62 countries The EC type examination consists of: Evaluation of the technical file delivered by the applicant and Testing of the PPE sample The Notified Bodies have to check the accordance of the products with the essential requirements and standards (Article 5 of Directive 89/686/EEC). EC type examination certificate (for products of category II and III) Declaration of Conformity (by the manufacturer) CE marking Category II Category III 7

8 What does an application for EC type examination require Business name and full address of the manufacturer (authorized representatives must also give all details of the manufacturer) Technical file according to Annex III An exhaustive list of the basic safety requirements and of the harmonized standards or other technical specifications, taken into account in the design of the model Copy of the information leaflet Written confirmation that he has not submitted the same file to another notified body And a suitable amount of PPE samples Technical documentation supplied by the manufacturer The documentation must comprise all relevant data on the means used by the manufacturer to ensure that a PPE complies with the basic requirements relating to it. 1. The manufacturer's technical file: a. overall and detailed plans of the PPE b. results of prototype tests in so far as necessary for the verification of compliance with the basic requirements c. an exhaustive list of the basic safety requirements and of the harmonized standards, 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 notice referred to in Annex II,

9 General requirements for protective clothing According to Appendix II of the Directive 89/686/EEC each protective clothing have to fulfil general requirements. This includes: appropriate ergonomically design lowest possible thermo-physiological stress for the user optimum protection level PPE must be so designed and manufactured as to preclude risks and other nuisance factors under foreseeable conditions of use. General requirements are given in EN 340:2003 which therefore must be a part of each garment certification. Risk-related requirements for protective clothing thermal protection (heat, flame, molten metal, electrical arcs) mechanical protection (cut, abrasion, ballistic) chemical protection (liquid, gas, dust) microbiological/nuclear protection protection against electrostatic charges foul weather protection (rain, cold) The technical (safety) product requirements where transferred into homogeneous European standards... 9

10 Risk-related requirements for protective clothing STFI s accreditation for EC Type Examinations includes: - Protective clothing for workers exposed to heat (EN ISO 11612) - Protective clothing for use in welding and allied processes (EN ISO 11611) - Protective clothing against thermal risks of an electrical arc (EN Serie) - Protective clothing for fire fighters (EN 469, ISO 11613, EN 13911) - High visibility warning clothing (EN 471, EN 1150) - Protective clothing for rescue services (GUV-R 2106) - Protective clothing against rain (EN 343) - Protective clothing against cool environments (EN 14058) - Protective clothing against cold (EN 342) - Chemical protective clothing Type 3, 4, 5, 6 (EN 13034, EN ISO , EN 14605) - Protective clothing against radioactive contamination (EN ) - Protective clothing against pesticides (DIN 32781) - Protective clothing with antistatic properties (EN 1149-Serie) - Protective clothing for use where there is a risk of entanglement with moving parts (EN 510) - Protective gloves against mechanical and thermal risks (EN 388, EN 407) - Protective gloves against chemicals and micro-organisms (EN 374) - Protective gloves for fire fighters (EN 659) - Protective gloves for welders (EN 12477) For many risk scenarios homogeneous European standards exist Material and garments tests according to harmonized European standards 10

11 Standardisation of Personal Protective Equipment (PPE) Standardisation Level International European National (Germany) Organisation ISO IEC CEN CENELEC DIN DKE International Organisation for Standardisation, Geneva International Electrotechnical Commission, Geneva European Committee for Standardisation, Brussels European Committee for Electrotechnical Standardisation, Brussels German Institute for Standardisation, Berlin German Commission for Electrotechnology, Frankfurt An enormous standardisation work is done to improve the protection effect of PPE products. Standardisation of Personal Protective Equipment (PPE) TC 162 Protective Clothing including hand and arm protection and lifejackets WG 1 WG 2 WG 3 WG 4 WG 5 WG 6 WG 7 WG 8 WG 9 WG 10 WG 11 WG 12 General requirements for protective clothing Resistance to heat and fire of protective clothing Protective clothing against chemicals, infective agents and radioactive contamination Protective clothing against foul weather, wind and cold Resistance to mechanical impact of protective clothing Lifejackets Visibility clothing and accessories Protective gloves Motorcycle rider protective clothing Buoyant aids for swimming instruction Body protection for sports Diving suits 144 published standards TC standards under development 11

12 Standardisation of Personal Protective Equipment (PPE) Once a standard is published in the Official Journal of the European Community and has been implemented as a national standard in at least one Member State, a presumption of conformity with the corresponding essential requirements of the PPE-Directive exists. EN :2008 Official Journal C 156/ Standardisation of Personal Protective Equipment (PPE) XEN XYZ:2008 How to proceed with a certification of protective clothing without an existing harmonised standard? For protection against risks, where no harmonised standard exists, the EC type examination has to be done based on the PPE-Directive only 12

13 EC-guideline 89/686/EEC for PPE Article 1 "...any device or appliance designed to be worn or held by an individual for protection against one ore more health and safety hazards". head protection Protective gloves protective clothing foot protection EC-guideline 89/686/EEC for PPE Article 1 PPE is only excepted from this guideline if it is covered by another directive or if it fulfils the following aspects: PPE designed and manufactured specifically for the armed force or in the maintenance of law and order (helmets, shields, bullet proof jackets) PPE for self-defense against attacker (aerosol devices, weapons,...) PPE designed and manufactured only for the use in a private area against: - adverse atmospheric conditions (seasonal clothing, footwear, umbrellas) - vapour and water - heat below 50 C PPE intended for the protection or rescue of passengers on airplanes or ships, not worn all the times 13

14 The manufacturer of the PPE must clarify the following 4 questions: 1. Does the product falls fall under a legislation, which requires the CE marking? 2. If YES, which requirements must be fulfilled that the product can be marked with the CE sign? 3. Which declarations or proofs for the fulfillment of the requirements must the manufacturer get? 4. What forces the CE marking to consider?? Differences between Protective Textiles / Safety Textiles Protection of persons Protection of objects Legal regulated working safety Personal Protective Equipment (PPE) Head (Helmet) Body (Clothing) Hand (Glove) Foot (Shoe) PPE against falls from a height PPE to prevent drowning Non legal regulated Private use only Leisure Sportswear Military garments Combined protection for personal/objects: Medical textiles Clean room garments ESD protection garments Textiles against fire Textiles against vandalism Protection against moisture Protection against corrosion 14

15 How can I prove conformity with the PPE Directive? What is required from the manufacturer in terms of declaration of conformity varies from the relatively simple procedure for Category 1 through to increasingly more detailed procedures for Category 2 and Category 3. The definitions of PPE categories are given at Art. 8 of the Directive. Overview about the categorisation principles Categorisation of PPE and requirements for the manufacturer Category Safety requirements Technical documentation supplied by the manufacturer EC- Type examination by notified body Quality-Control- System for product checked by notified body EC- Declaration of conformity supplied by the manufacturer I simple yes no no yes II medium yes yes no yes III complex yes yes yes yes 15

16 Marking - Each piece of protective clothing shall be marked The marking shall be: - in the languages of the state of destination - visible an legible on the product or labels - durable to the given cleaning processes The marking have to contain: - Business name, company logo or other identification of the manufacturer - Type, name or any other identification of the product - Material description - European standard - Pictogram for the risk which the product should protect against, including performance classes - Information about sizing - Care labels The information brochure supplied by the manufacturer These notes (According to Annex II 1.4) intend for the user of the PPE must be precise and comprehensible and must be provided at least in the official language of the Member State of destination. Content: Business name and full address of the manufacturer Name, address and identification number of the notified body involved in the design stage of the PPE Name of the product The harmonized European standard with year of publication performance as recorded during technical tests to check the levels or classes of protection provided by the PPE Classes of protection and the corresponding limits of use Suitable PPE accessories and parts Exploitation of pictograms and performance classes Information about storage, use, cleaning, maintenance, and the obsolescence deadline 16

17 Model EC Declaration of Conformity The manufacturer or his authorized representative established in the Community ( 1 ):... declares that the new PPE described hereafter ( 2 )... is in conformity with the provisions of Council Directive 89/686/EEC and, where such is the case, with the national standard transposing harmonized standard N... (for the PPE referred to in Article 8 (3)) is identical to the PPE which is the subject of EC certificate of conformity N... issued by (³)... is subject to the procedure set out in Article 11 point A or point B of Directive 89/686/EEC under the supervision of the notified body (³).... Done at..., on... Signature ( 4 ) (¹) Business name and full address; authorized representatives must also give the business name and address of the manufacturer. (²) Description of the PPE (make, type, serial number, etc.). (³) Name and address of the approved body. ( 4 ) Name and position of the person empowered to sign on behalf of the manufacturer or his authorized representative. Thank you for listening and time for questions 17