1、EIA STANDARD I Electrical and Electronic Components and Products Hazardous Substance Free Standard and Requirements EIA/ECCB-954 March 2005 The Electronic Components Certification Board United States National Authorized Institute for the IECQ-CECC Electronic Componente, Assemblies 8 Materials Associ
2、ation THE ELECTRONIC COMPONENT SECTOR OF THE ELECTRONIC INDUSTRIES ALLIANCE NOTICE EIA Engineering Standards and Publications are designed to serve the public interest through eliminating misunderstandings between manufacturers and purchasers, facilitating interchangeability and improvement of produ
3、cts, and assisting the purchaser in selecting and obtaining with minimum delay the proper product for his particular need. Existence of such Standards and Publications shall not in any respect preclude any member or nonmember of EIA from manufacturing or selling products not conforming to such Stand
4、ards and Publications, nor shall the existence of such Standards and Publications preclude their voluntary use by those other than EIA members, whether the standard is to be used either domestically or internationally. Standards and Publications are adopted by EIA in accordance with the American Nat
5、ional Standards Institute (ANSI) patent policy. By such action, EU does not assume any liability to any patent owner, nor does it assume any obligation whatever to parties adopting the Standard or Publication. This EIA Standard is considered to have International Standardization implication, but the
6、 International Electrotechnical Commission activity has not progressed to the point where a valid comparison between the EIA Standard and the IEC document can be made. This Standard does not purport to address all safetyproblems associated with its use or all applicable regulatory requirements. It i
7、s the responsibility of the user of this Standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations before its use. (From Standards Proposal Number 5087, formulated under the cognizance of the Electronic Component Certification Board (E
8、CCB) Committee TPC 1 Test Plans.) Published by ELECTRONIC INDUSTRIES ALLIANCE 2005 Technology Strategy or, if the products are not HSF, the quantitative amounts of HS that are present. The processes used to identi, control, quanti, and report the HS content in an electrical or electronic component,
9、or an element thereof, must be defined and understood in sufficient detail to assure all concerned parties of the HSF status of a product. The processes must be appropriately documented and conducted in a controlled and consistent manner, to facilitate verification of compliance to applicable requir
10、ements and regulations; to allow efficient and effective compliance checks; that it can be implemented by producers and users in many different locations; and to allow harmonization of compliance and enforcement methods. Above all, they must minimize technical barriers to the trade of products aroun
11、d the world. 2. Purpose of this document This document is intended for use by: 1. manufacturers, suppliers, repairers, and maintainers of products to develop processes to identie, control, quanti, and report the amounts of HS in the products they manufacture or supply; and 2. customers and users of
12、the products to know the HSF status of a product, and to understand the processes by which it is determined. EIA/ECCB-954 Page 2 3. Scope This document defines the requirements for establishing processes to identify and control the introduction of hazardous substances (HS) into its products. In the
13、event that hazardous substances are introduced into the products, this document defines the requirements for implementing processes to test, analyze, or otherwise ascertain the HS content, and to make it available to the customer. Documented processes shall be within the organizations business and q
14、uality management systems. 4. References _ _ Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS). Directive 2002/96/EC of the European Parliament and of the C
15、ouncil of 27 January 2003 on Waste Electrical and Electronic Equipment (WEEE). IS0 900 1 :2000, Quality Management Systems - Requirements IS0 10005: 1995, Quality Management - Guidelines for quality plans IS0 10006: 1997, Quality management - Guidelines to quality in project management IS0 1901 1, G
16、uidelines on quality and/or environmental management systems auditing IEC QC 001002-3, Rules of Procedure, Part 3: Approval procedures AS 91 00, Quality Systems Aerospace Model for Quality Assurance in Design, Development, Production, Installation and Servicing TL 9000 Quality Management System (QMS
17、) Requirements IS0 13485 Medical devices - Quality management systems - System requirements for regulatory purposes 5. Terms and Definitions For purposes of this document, the following terms and definitions apply. HS Hazardous Substance refers to any material as listed in the WEEE or RoHS as prohib
18、ited from usage and is interchangeable with Restricted Substances. HSF Hazardous Substances Free refers to the reduction or elimination of any material as listed in the WEEE or RoHS directives or other applicable standards or regulations. EIA/ECCB-954 Page 3 Information services provider refers to a
19、n entity or organization that analyzes, monitors, or provides information for use in conjunction with designing, procuring, manufacturing, maintaining or supporting products for which the lead content should be known. May indicates a course of action that is permissible within the limits of this doc
20、ument. Product customer refers to an entity or organization that purchases a product, either for use or re- sale. Product maintainer refers to an entity or organization that is responsible for keeping a product available for service, after it has been placed in service. Product manufacturer refers t
21、o an entity or organization that manufactures a product or set of products for which the hazardous substances content must be known on a quantitative basis. Product repairer refers to an entity or organization that repairs or restores a product to service after it fails in service. Product supplier
22、refers to an entity or organization that (a) distributes a product obtained from a manufacturer to a subsequent customer or user; or (b) integrates a manufactured product into a higher level product that is supplied to a subsequent customer or user. Product user refers to an entity or organization t
23、hat uses an item after it has been placed in service. Restricted Substance refers to any material as listed in the WEEE or RoHS as prohibited from usage and is interchangeable with HS Shall indicates a mandatory requirement to be followed in order to conform to this document. Should indicates that,
24、among several possibilities, one is recommended as particularly suitable, without mentioning or excluding others; or that a certain course of action is preferred but not necessarily required; or that (in the negative form) a certain course of action is deprecated but not prohibited. EIA/ECCB-954Page
25、 4 Customerrequirements forHSFStatutory andregulatoryrequirements forHSFContract Reviewto ensurecapabilityOrganization Planfor themanagement ofHSFDesign review todetermineconformance toHSFrequirementsOperationsHSFManufacturingprocess controlsHSFMaterials processManagementHSFSupply Chainprocess contr
26、olsHSF QualityAssuranceprocessesDocument design aspects and impacts thatare controlled per the organizations list ofHSF materialsWEEE, RoHS, EPA,ISO 14001, etc.Document Processes for the receiving,storage, segregation and shipping of partsor products throughout the organization, itssubsidiaries and
27、suppliers.Document controls of all processes for themanufacture, supply or repair of parts orproducts throughout the organization, itssubsidiaries and suppliers.Document processes for approval ofsuppliers and HSF compliance control inthe procurement of all parts and/or productsusedDocument the seque
28、nce of review andapproval of all processes used to produceparts or products. This applies to Suppliersof parts and Subcontractors of assemblies.Document the assessment and control ofcorrective actions taken onnonconformities throughout theorganizations, its suppliers andsubcontractors operationsDocu
29、ment policies andobjectives evidencingthe organizationscommitment to HSFconformity.Document the processfor ensuring complianceto customerrequirements of HSFconformity.Structure for the achievement of Hazardous Substance Free operationsDocument the process for determiningcompliance to stated HSF poli
30、cies andobjectives.This model illustrates the minimum requirements of this standard,but does not show processes at a detailed levelEIA/ECCB-954 Page 5 6. General Requirements 6.1. Quality Management System Each organization shall include in its IS0 9001 :2000 mandated quality management system the p
31、rocedures, documentation, and process management practices necessary to achieve HSF product and production processes. 6.1.1. The organization shall 6.1.1.1 .identi and document all hazardous substances in use in the organization. 6.1.1.2.identifi the specific processes to be managed relevant to its
32、HSF goals. 6.1.1.3.determine the interdependence and interaction of these processes and develop 6.1.1.4.establish criteria upon which to objectively determine the effectiveness of the 6.1.1 S.ensure the availability of resources and information needed to support 6.1.1 .monitor, measure and analyze t
33、hese processes, and 6.1.1.7.implement actions to ensure continuous process improvement in achieving 6.1.1 . 9.1.2.2.the need to establish HSF processes, documents, and provide resources 9.1.2.3.required verification, validation, monitoring, inspection and test activities specific to the HSF product;
34、 specific to the HSF product and the criteria for product acceptance. This shall include information services providers as appropriate; use of restricted substances to include prevention where the possibility of contamination exists. 9.1.2.4. documented procedures or work instructions for processes
35、that include the 9.1.2.5. records needed to provide evidence that the HSF realization processes and resulting product meet requirements. The output of this HSF planning shall be in a form suitable for the organizations method of operations. Note 1 : A document specikng the HSF processes (including t
36、he product realization processes) and the resources to be applied to a specific product can be referred to as a quality plan. 9.2. Determination of requirements related to the HSF product 9.2.1.1 .The organization shall determine 9.2.1.1.1. HSF requirements specified by the customer, 9.2.1.1.2. HSF
37、requirements not stated by the customer but necessary for 9.2.1.1.3. HSF statutory and regulatory requirements related to the product, and 9.2.1.1.4. any additional HSF requirements determined by the organization. specified or intended uses, where known. 9.3. Review of HSF requirements related to th
38、e product 9.3.1.1 .The organization shall review the requirements related to the HSF product. This review shall be conducted prior to the organizations commitment to supply HSF product to the customer and shall ensure that; EIA/ECCB-954 Page 10 9.3.1.1.1, HSF product requirements are defined, and 9.
39、3.1.1.2. the organization has the ability to meet the HSF defined requirements. 9.3.1.1.3. any use of or possibility of contamination or mixing of processes or product that contain restricted substances shall be communicated to the customer. 9.3.1.1.4. Records of the results of the HSF review and ac
40、tions arising from the review shall be kept and maintained. 9.4. Design and development 9.4.1.1 .HSF design and development planning 9.4.1.1.1. The organization shall plan and control the design and development of 9.4.1.1.2. In planning the design, the use of any restricted substance shall be HSF pr
41、oduct. identified in the documentation and a plan for control and eventual replacement/elimination of the part. 9.4.1.2.HSF Design and development inputs records maintained. complete, unambiguous and not in conflict with each other. 9.4.1.2.1. Inputs relating to HSF product requirements shall be det
42、ermined and 9.4.1.2.2. HSF inputs shall be reviewed for adequacy. Requirements shall be 9.4.1.3 .HSF Design and development outputs 9.4.1.3.1. The HSF outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approve
43、d prior to release. 9.4.1.3.2. When the design requires the use of a restricted substance a documented procedure shall be developed for the control, identification, monitoring and measurement of the process/product to include subcontracted product. 9.4.1.4.HSF Design and development review 9.4.1.4.1
44、. At suitable stages, systematic reviews of the design and development shall be performed in accordance with the HSF plan. 9.4.1 S.control of HSF design and development changes 9.4.1.5.1. HSF design and development changes shall be identified and records maintained. The changes shall be reviewed, ve
45、rified and validated, as appropriate, and approved before implementation. 9.5. Purchasing of HSF products EIA/ECCB-954 Page 11 9.5.1.1.1. The organization shall ensure that procured product conforms to HSF requirements. 9.5.1.1.2. the organization shall evaluate and select suppliers based on their a
46、bility to supply product in accordance with the organizations HSF requirements. possible contamination with a restricted substance. purchase document and upon receipt of the material. 9.5.1.1.3. the organization shall ensure that any HSF partmaterial is free from 9.5.1.1.4. procurement of restricted
47、 substances shall be clearly identified on the 9.5.1.2.Verification of HSF purchased product 9.5.1.2.1. The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified HSF purchase requirements. 9.5.1.2.2. The procuremen
48、t route of purchased goods shall be fully understood and any process that has the possibility of contamination by restricted hazardous substances shall be fully identified. A documented procedure shall outline the procurement activities related to the HSF process. of Hazardous substances included in
49、 purchased goods. The hazardous substance shall be identified by the type in the inspection data. 9.5.1.2.3. Establish a documented procedure for the inspection and identification 9.5.1.2.3.1.included shall be a process to handle an abnormality/nonconforance. 9.5.1.2.4. If the processes are combined with each other a documented procedure shall be established to differentiate between parts. 9.6. Production and service provision 9.6.1. Control of HSF production and service provision processes 9.6.1.1 .The organization shall plan HSF production and service provisions
