1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 50581:2012Technical documentation forthe assessment of electricaland electronic products withrespect to the restriction ofhazardous substancesBS EN 50581:2012 BRITISH STAND
2、ARDNational forewordThis British Standard is the UK implementation of EN 50581:2012.The UK participation in its preparation was entrusted to TechnicalCommittee GEL/111, Electrotechnical environment committee.A list of organizations represented on this committee can beobtained on request to its secre
3、tary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 78645 7ICS 29.020; 31.020Compliance with a British Standard cann
4、ot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2012.Amendments issued since publicationDate Text affectedBS EN 50581:2012EUROPEAN STANDARD EN 50581 NORME EUROPENNE EUROPISCHE NORM Septembe
5、r 2012 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2012 CENELEC - All rights of exploitation in any form and by any means reserv
6、ed worldwide for CENELEC members. Ref. No. EN 50581:2012 E ICS 29.020; 31.020 English version Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances Documentation technique pour lvaluationdes produits lectriques et lec
7、troniques par rapport la restriction des substances dangereuses Technische Dokumentation zur Beurteilung von Elektro- und Elektronikgerten hinsichtlich der Beschrnkung gefhrlicher Stoffe This European Standard was approved by CENELEC on 2012-07-16. CENELEC members are bound to comply with the CEN/CE
8、NELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre
9、 or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status
10、as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, L
11、uxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 50581:2012EN 50581:2012 2 Contents Foreword . 3Introduction . 41 Scope 52 Normative references . 53 Terms and definitions . 54 Technical document
12、ation 54.1 Overview . 54.2 Content of the technical documentation 54.3 Information on materials, parts, and/or sub-assemblies . 64.3.1 Tasks to be undertaken by the manufacturer 64.3.2 Determine the information needed . 64.3.3 Collecting information 74.3.4 Evaluation of information . 74.3.5 Review o
13、f the technical documentation 8Annex A (informative) Relationship between Directive 2011/65/EU and the technical documentation . 9Annex ZZ (informative) Coverage of Essential Requirements of EU Directives 10Bibliography 11BS EN 50581:2012 3 EN 50581:2012 Foreword This document (EN 50581:2012) has be
14、en prepared by CLC/TC 111X “Environment“. The following dates are fixed: latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2013-07-16 latest date by which the national standards conflicting with this do
15、cument have to be withdrawn (dow) 2015-07-16 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a m
16、andate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 2011/65/EU. For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this document. BS EN 50581:2012EN 50581:2012 4 Int
17、roduction Certain substances contained in electrical and electronic products are restricted by legislation and/or customer specifications. Manufacturers of final products therefore need to be able to demonstrate that their products meet the applicable substance restrictions. For those restrictions t
18、hat apply at the “homogeneous material“ level, it is impractical for manufacturers of complex products to undertake their own testing of all materials contained in the final assembled product. Instead, manufacturers work with their suppliers to manage compliance and compile technical documentation a
19、s evidence of compliance. This approach is well recognised by both industry and enforcement authorities. The aim of this European Standard is to specify the technical documentation that the manufacturer needs to compile in order to declare compliance with the applicable substance restrictions. In th
20、is way, this European Standard supports Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS). This European Standard can also find an application in demonstrating
21、conformity to other substance regulations worldwide. BS EN 50581:2012 5 EN 50581:2012 1 Scope This European Standard specifies the technical documentation that the manufacturer needs to compile in order to declare compliance with the applicable substance restrictions. The documentation of the manufa
22、cturers management system is outside the scope of this European Standard. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated refe
23、rences, the latest edition of the referenced document (including any amendments) applies. EN 62321:2009, Electrotechnical products Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers) (IEC 62321:20
24、08) NOTE EN 62321 will be replaced by a series of standards designated EN 62321-x. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 restricted substance substance which is limited in its use in a product, part or material 3.2 manufacturer natu
25、ral or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark SOURCE: Regulation (EC) N 765/2008 or Decision N 768/2008/EC Note 1 to entry: In certain circumstances, an importer or distributor is considered a manufactur
26、er for the purposes of Directive 2011/65/EU. 3.3 supplier organisation that provides the manufacturer with materials, parts and/or sub-assemblies 4 Technical documentation 4.1 Overview The manufacturer shall compile technical documentation to demonstrate that electrical and electronic products compl
27、y with substance restrictions (see 4.2 and 4.3). 4.2 Content of the technical documentation The technical documentation shall include at least the following elements: a general description of the product; NOTE 1 Directive 2011/65/EU specifies 11 product categories. The product category is one of the
28、 factors that determines which exemptions apply. documents for materials, parts, and/or sub-assemblies (see 4.3); information showing the relationship between the technical documents identified in 4.3 and the corresponding materials, parts and/or sub-assemblies in the product; BS EN 50581:2012EN 505
29、81:2012 6 list of harmonized standards and/or other technical specifications that have been used to establish the technical documents identified in 4.3, or to which such documents refer. NOTE 2 Annex A describes the relationship between Article 7(b) of Directive 2011/65/EU, Module A of Decision 768/
30、2008/EC, this European Standard, and the technical documentation. 4.3 Information on materials, parts, and/or sub-assemblies 4.3.1 Tasks to be undertaken by the manufacturer The manufacturer shall undertake the following four tasks: determine the information needed (see 4.3.2); collect the informati
31、on (see 4.3.3); evaluate the information with regard to its quality and trustworthiness and decide whether to include it in the technical documentation (see 4.3.4); ensure that the technical documentation remains valid (see 4.3.5). Figure 1 (informative) shows the process to create the technical doc
32、umentation: Documents for materials, parts, and/or sub-assembliesGeneral description of the productDocuments for materials, parts, and/or sub-assembliesList of harmonized standards and/or other technical specificationsthat have been used to establish the technical documents mentioned in 4.3, or to w
33、hich such documents referInformation showing the relationship between the documents and the corresponding materials, parts and/or sub-assemblies in the productContent of the Technical DocumentationMaterialDeclarationsSupplier historical likelihood of restricted substances being present in each mater
34、ial type; historical experience with the supplier organization; results of previous supplier inspections or audits. NOTE 2 The assessment and its associated procedures can form part of a quality management system or equivalent. 4.3.3 Collecting information As a result of the manufacturers assessment
35、, the following documents on materials, parts, and/or sub-assemblies shall be collected: a) Supplier declarations and/or contractual agreements, such as: Supplier declarations, confirming that the restricted substance content of the material, part, or sub-assembly is within the permitted levels and
36、identifying any exemptions that have been applied; Signed contracts confirming that the manufacturers specification for the maximum content of restricted substances in a material, part, or sub-assembly is fulfilled. Such declarations or agreements shall cover a specific material, part and/or sub-ass
37、embly, or a specific range of materials, parts and/or sub-assemblies. and/or b) Material Declarations: Material declarations providing information on specific substance content and identifying any exemptions that have been applied. NOTE 1 The use of standards for such declarations helps ensure consi
38、stent and cost-effective flow of information throughout the supply chain. EN 62474 “Material declaration for products of and for the electrotechnical industry” describes the procedure, content, and form relating to material declaration. Other specifications for material declarations are also used in
39、 industry today. and/or c) Analytical test results: Analytical test results using the methods described or referenced in EN 62321. NOTE 2 EN 62321 will be replaced by a series of standards designated EN 62321-x. 4.3.4 Evaluation of information The manufacturer shall establish procedures that shall b
40、e used to evaluate the documents described in 4.3.3 in order to determine their quality and trustworthiness. NOTE 1 IEC/TR 62476 provides a framework for the use of internationally accepted standards, tools and practices to evaluate electrical and electronic products with respect to restricted subst
41、ances. The manufacturer shall evaluate, in accordance with these procedures, the source and content of each document received in order to determine whether or not the material, part, or sub-assembly meets the specified substance restrictions. NOTE 2 The substance restrictions specified in Directive
42、2011/65/EU apply at the homogeneous material level. BS EN 50581:2012EN 50581:2012 8 This evaluation will enable the manufacturer to decide whether the documents provide sufficient evidence of compliance to justify their inclusion in the technical documentation. If a particular document is: considere
43、d to be of sufficient quality and trustworthiness, then it shall be included in the technical documentation; not considered to be of sufficient quality or trustworthiness, then the manufacturer shall determine what further actions are necessary possible actions include requesting additional informat
44、ion from the supplier or undertaking his own substance analysis. 4.3.5 Review of the technical documentation The manufacturer shall: perform a periodic review of the documents contained in the technical documentation to ensure that they are still valid; ensure that the technical documentation reflec
45、ts any changes to materials, parts or sub-assemblies in accordance with 4.3.3. NOTE Directive 2011/65/EU requires that “manufacturers ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standard
46、s or in technical specifications by reference to which conformity of EEE is declared shall be adequately taken into account”. BS EN 50581:2012 9 EN 50581:2012 Annex A (informative) Relationship between Directive 2011/65/EU and the technical documentation Figure A.1 shows the relationship between Art
47、icle 7(b) of Directive 2011/65/EU, Module A of Decision 768/2008/EC, this European Standard, and the technical documentation: Figure A.1 Relationship between Directive 2011/65/EU and the technical documentation covered by this standard BS EN 50581:2012EN 50581:2012 10 Annex ZZ (informative) Coverage
48、 of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Article 7 of Directive 201
49、1/65/EU. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other Directives may be applicable to the products falling within the scope of this standard. BS EN 50581:2012 11 EN 50581:2012 Bibliography EN 62474:2012, Material declaration for products of and for the electrotechnical industry (IEC 62474:2012) EN 62430:2
