EU approach to product certification in the electrical and mechanical engineering sectors Harald Riekeles - VDMA Frank

1. EU approach to product certification in theelectrical and mechanical engineering sectorsHarald Riekeles - VDMA FrankfurtBeijing, 20.September 2004

2. The World Standards and Certificats Market ISO, IEC ANSI,............... CEN, CENELEC ANSI, ASME, ASTM, NFPA, NEMA, SAE, ... EU NAFTA CE UL AsiaPacific e.g. ASEAN APEC, … AIDMO CCC China MERCOSUR

3. Background of European Certification:1985 - European New Approach--------------------------------------------- Technical Rules defined in - compulsory Directives with general Essential (Safety) Requirements - voluntary Harmonised Standards specifying the Essential Requirement(s) Mandated Harmonised Standards referenced in the Official Journal of European Communities grant Presumption of Conformity

4. Information in Mandated Harmonised Standards on Presumption of Conformity • ANNEX Z ( in EN and ISO/DIS under Parallel Procedure ) (informative)Relationship between this European Standard and the Essential Requirements of EU Directive ......... • This European Standard has been prepared ....... to provide one means of conforming to Essential Requirements of the New Approach Directive ......... • Once this standard is cited in the OJEC under that Directiveand has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard (( except clause(s) ............)) confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements(( except Essential Requirement(s)...............)) of that Directive ....... • WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

5. EU Directives for Electrical and Mechanical Engineering Products Conformity Assessment The Manufacturer or his authorised representative or any person placing the product on the market, declares the conformity of the product with the provisions of all related Directives: • assures compliance with the Essential Requirements, by preferential application of Harmonised Standards; • establishes a Technical File / Documentation; • establishes Instructions for Use; • for certain very dangerous products or high risks involves a Notified Body; • issues a Declaration of Conformity; • affix the CE-mark on the product or packaging.

6. EU Directives for Electrical and Mechanical Engineering Products Conformity Assessment - 2 - The Manufacturer or his authorised representative establishes aTechnical File / Documentation: • proving compliance with the Essential Requirements by a Risk Assessment with description of the Measures to eliminate or reduce the risks, preferably apply Harmonised Standards • in one of the Communities’ languages, held available for authorities at least 10 years, depending of the Directive - at the manufacturer‘s premises or - in the Community (EU, EFTA

7. EU Directives for Electrical and Mechanical Engineering Products Conformity Assessment - 3 - The Manufacturer or his authorised representative establishes Instructions for Use: • considering intended use and reasonably foreseeable misuse • in the official language(s) of the country in which the product is to be used, and depending of the Directive, in the original language • maintenance instructions for use by special personal of the manufacturer may be in the language understood by this personal

8. EU Directives for Electrical and Mechanical Engineering Products Conformity Assessment - 4 - The Manufacturer or his authorised representative carries out the Verification / Testing • by self internal production control - manufacturer’s self declaration - or • for certain very dangerous products or high risks involves a Notified Body for - deposit of Technical Documentation or - verification of Technical Documentation or - Product verification or - EC type examination or / and - Product or Production Quality Assurance or - Full Quality Assurance

9. EU Directives for Electrical and Mechanical Engineering Products Conformity Assessment - 5 - The Manufacturer or his authorised representative or any person placing the product on the market • issues an EC Declaration of Conformity for each related Directive, - accompanying the product or - remaining at the manufacturer’s premises or • issues a Manufacturer’s Declaration - for partly completed machinery - • and finally affix the CE-mark on the product or packaging

10. "CE" Machinery 98/37 70/156 (former 89/392) "CE" motor vehicles/trailers simple 74/150 pressure vessels agricult./forestry tractors 87/404 "CE" pressure equipment 97/23 agents 80/1107 ( 98/24) at work "CE" work noise safety outdoors 89/391 2000/14 (89/655 etc.) "CE" ATEX "CE" 94/9 EMC "CE" 89/336 low voltage 73/23 "CE" lifts 95/16 product liability EC- Directivesrelated to Machinery EC- Directives related to Machinery

11. The Hierarchy of Machinery Standards A a A b A c Type A Standards B a B b Type B Standards Bc Aa Aa Ab Ab Ba Type C Standards Reference to A- and B-Standards Machine specific aspects“added value”

13. Issued:540 EN .thereof480EN by CENplus 245 Draft prEN (further started 90 Rev./Amend.)60 EN by CENELEC Referenced in OJEC20th April 2004: ----------------------------------- 475 Harmonised EN: 90 type A + B 280 type C machinery, . incl. 35 for Annex IV 105 type C equipment or . aspects Mandated Standards Programme Directive 98/37/EC - Safety of Machinerystate 30th April 2004

16. EN ISO 12100-1 : 2003 -; Basic terminology, methodology EN ISO 12100-2 : 2003 -; Technical principles approved by: all 28 CEN-members Australia Belarus Brazil Canada China Japan Korea, Republic of Malaysia Turkey Revision of EN 292-1 and -2:1991 Safety of machinery - Basic concepts, general principles for design

19. Informations on European Directives and Standards • EU >> europa.eu.int/eur-lex/en/index.htm • CEN >> www.cenorm.be >> work area >> sector fora • New Approach -Directives/StandProgram/Harm.Stds . >> www.newapproach.org/directives • DIN - Guide to Safety of Machinery in Europe . (3 paper files or CD-ROM)

20. Informations on Safety of Machinery