1、Designation: F2577 14Standard Guide forAssessment of Materials and Products for DeclarableSubstances1This standard is issued under the fixed designation F2577; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisi
2、on. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide uses case studies to illustrate the decisionprocess to assess materials and products for declarable sub-stances when e
3、valuating conformance to relevant require-ments. This may be accomplished by applying existing knowl-edge to determine the need for further action (for example,testing).1.2 This guide is limited to the referenced European Uniondirectives. Other regions, countries, states or local municipali-ties may
4、 adopt these or similar regulations.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limi
5、tations prior to use.2. Referenced Documents2.1 ASTM Standards:2F2576 Terminology Relating to Declarable Substances inMaterials2.2 Other Documents:DTI ROHS Regulations Government Guidance Notes, No-vember 2005, SI 2005 No. 27483European Commission Decision 2005/618/EC CommissionDecision of 18 August
6、 2005 amending Directive 2002/95/EC of the European Parliament and of the Council forthe purpose of establishing the maximum concentrationvalues for certain hazardous substances in electrical andelectronic equipment4European Union Directive 2011/65/EU (recast of 2002/95/EC) on the Restriction of the
7、 Use of Certain HazardousSubstances in Electrical and Electronic Equipment5European Union Directive 2012/19/EU on Waste Electricaland Electronic Equipment63. Terminology3.1 Terms and definitions related to declarable substances inmaterials may be found in Terminology F2576.3.2 Terms and definitions
8、in the guide not found in Termi-nology F2576 may be found in a common dictionary or otherreference documents such as the ASTM Dictionary of Engi-neering Science notified underdocument number C(2005) 3143.5Official Journal of the European Union, L174/88 08.06.2011.6Official Journal of the European Un
9、ion, L 197/1 04.07.2012.7Sponsored by ASTM Committee E02 on Terminology; available from ASTMInternational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959; ASTM Stock Number: DEF00.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959.
10、 United States1material, a test method may be required to verify or generateinformation on the concentration of that substance within (oron) the material.4.4 Test methods can be used as a means to verify andprovide information related to substances within materials. Atthe same time, misinformation c
11、an be generated or inappropri-ate conclusions drawn when test methods are misapplied. Thisguide is intended to provide recommendations on the applica-tion of test methods.4.5 Test methods may be applied by producers or by interimor end users of materials. However, it is not necessary or costeffectiv
12、e to test materials at each stage of production. Thedecision to apply test methods and the frequency of testingshould be based on risk perceived by the user or can be a matterof agreement.4.6 Assessment of plastics for presence of declarable sub-stances is more complex than assessment of metals and
13、alloys,since the possible ingredients are comparatively much morenumerous in plastic manufacture.4.7 This guide includes a general process and case studies inorder to provide guidance and to distinguish where a priori anda posteriori knowledge should be applied. Flow charts as aguide for assessment
14、of materials and products are provided inAppendix X1.5. General Process of Assessment of Materials andProducts for Conformance with Requirements5.1 The process of assessing materials and products forconformance with requirements may be broken down into thefollowing steps:5.1.1 Determine if the mater
15、ial or product is covered underthe scope of the requirements, taking into account any exemp-tions from the scope.5.1.2 Establish the basis of conformance to which limits forsubstances given in the requirements apply.5.1.2.1 List each material to be assessed and assess each onan individual basis.5.1.
16、3 If appropriate, apply a priori knowledge of the mate-rial and its manufacture to assess the probability of whethereach declarable substance may be present.5.1.4 As necessary, obtain a posteriori knowledge of sub-stance concentrations based upon observations or empiricaldata from the material.5.1.5
17、 Assess the material or product for conformance torequirements based upon a priori and a posteriori information.5.1.5.1 If the basis of conformance to requirements is eachmaterial within a product, assess each material separately fordeclarable substances content.5.1.5.2 If the basis of conformance t
18、o requirements is theentire product, assess the cumulative contribution of declarablesubstances in materials for the entire product5.1.6 Document the assessment process for each material orproduct.5.2 Determine if the material or product is covered underthe scope of the requirements, taking into acc
19、ount any exemp-tions from the scope. Requirements may be regulations orstipulations by clients, that is, they may be statutory or byagreement. The first step in any assessment is to determinewhat is covered by requirements, or the scope of the require-ments. In some cases exemptions to the scope are
20、 allowed, soit is important to establish whether a particular material orproduct falls under the scope and whether the product ormaterial is exempt from that scope.5.3 Establish the basis of conformance to which limits forsubstances given in the requirements apply. Requirements inthe form of substan
21、ce restrictions or declaration limits typicallylist concentrations of substances above which the product ormaterial is considered non-conforming or the substances mustbe declared. It is important to determine the basis to which thelimits apply in order to properly assess conformance. Forexample, the
22、 limits may apply to an entire product or they mayapply to each material within the productNOTE 1Limits of “zero” for substances or statements such as“products shall not contain” certain substances are indeterminate. Prod-ucts or materials cannot be assessed to such limits without accounting forand
23、identifying every atom constituting the product or material beingassessed.5.4 If appropriate, apply a priori knowledge of the materialand its manufacture to assess the probability whether eachdeclarable substance may be present. Lists of declarablesubstances in requirements may have been set with li
24、ttle or noregard to material types to be assessed. Through application ofa priori knowledge of specific materials it may be possible toeliminate the need to gather empirical data for certain sub-stances listed in the requirements.NOTE 2A priori knowledge requires justification based upon scientificp
25、rinciples and logical deduction. For example, the statement that it is notnecessary to determine the hexavalent chromium concentration withinwrought metals is based upon knowledge of metallurgy and atomicstructure.5.5 As necessary, obtain a posteriori knowledge of sub-stance concentrations based upo
26、n observations or empiricaldata from the material. Data on substance concentrationswithin or on materials may be obtained from suppliers in theform of Certificates of Analysis or a laboratory report of a lot,batch or heat of material. While it is not necessary to confirmeach and every certificate ob
27、tained from suppliers via repeti-tion of testing, it is good practice to periodically confirmmaterial data.5.6 Assess the material or product for conformance torequirements based upon a priori and a posteriori information.The concentrations of any declarable substances in materials orproducts are co
28、mpared to the limits set by the requirements inorder to determine conformance or non-conformance. While aposteriori information in the form of empirical data may bedirectly compared to limit values, a priori information mayindicate that it is not appropriate to assess conformity ofmaterials for cert
29、ain substances.NOTE 3A priori knowledge that a substance cannot be present in amaterial precludes the possibility of generating empirical data for thatsubstance within that material. It is appropriate to state in such cases thatconformity assessment is not applicable.5.7 Document the assessment proc
30、ess for each material orproduct. Documentation in the form of data and illustration ofthe assessment process is necessary to back up statements ofcompliance for materials and productsF2577 1426. Case Studies6.1 A finished aluminum part is to be evaluated for confor-mance to the requirements of Europ
31、ean Union Directive2002/95/EC on the Restriction of the Use of Certain HazardousSubstances in Electrical and Electronic Equipment (RoHS). Itwas established that the part would be incorporated into afinished electrical product to be sold on the European marketafter the effective date of the RoHS Dire
32、ctive and the finishedproduct fits the description of electrical products to be regu-lated per the RoHS Directive and European Union Directive2011/65/EU (recast of 2002/95/EC) on Waste Electrical andElectronic Equipment (WEEE).6.1.1 The chemical requirements of the RoHS Directive aregiven in Europea
33、n Commission Decision 2005/618/EC asfollows: the Maximum Concentration Value (MCV) for lead,mercury, hexavalent chromium, polybrominated biphenyls(PBB) and polybrominated diphenyl ethers (PBDE) is 0.1% byweight per homogeneous material and the MCV for cadmiumis 0.01% by weight per homogeneous materi
34、al. Per the Annexof the RoHS Directive, aluminum is exempt from the restric-tion on lead and is allowed to contain up to 0.4% by weightlead. No other exemption was applicable to the aluminum part.6.1.2 A priori knowledge of aluminum and its method ofmanufacture were used to evaluate the part. Alumin
35、um is notflammable under normal conditions, so there is a low probabil-ity that flame retardants such as PBB or PBDE were part of theformulation. Furthermore, the temperature of a typical alumi-num smelter is maintained at 920C 980C at which organicsubstances such as PBB or PBDE are decomposed and b
36、ecomevolatile gases, so organic substances will not remain in thefinished aluminum metal. While metal alloys may contain theelement chromium, the chromium within the metal is in themetallic state with an atomic valence of zero. With regard tometals, hexavalent chromium is not found within the metal
37、butmay be found on the exterior surfaces in the form of a chromateconversion coating. Hexavalent chromium may also be foundin coatings such as paint and plastic since hexavalent chro-mium compounds have been employed as pigments in suchmaterials. Lead may be found in some free machining alumi-num al
38、loys at levels above the RoHS MCV. Cadmium can befound in aluminum as a contaminant, but is added intentionallyin only two alloys (2021 and 4013) which are not commonlyproduced at this time. Mercury is volatile and is not likely to befound in aluminum or its alloys, though there are someformulations
39、 used as sacrificial anodes containing mercury at0.03 to 0.06% Small concentrations of mercury in aluminumwill cause the aluminum to be rapidly oxidized and convertedinto aluminum oxide, so a piece of solid aluminum is unlikelyto contain more than 0.1% mercury.6.1.3 Application of a priori knowledge
40、 of aluminum andits manufacture results in a preliminary assessment concerningthe presence of certain substances. The preliminary assessmentof the aluminum part to the requirements of RoHS points towhich substances should be measured and which should not:there is a good probability that cadmium or l
41、ead may be presentwithin the aluminum part; there is a low probability thatmercury may be present and there is a possibility that hexava-lent chromium may be found on the surface of the part.Conversely, there is low probability that PBB or PBDE arepresent in the aluminum. Completing the evaluation o
42、f thealuminum part to RoHS requirements requires a posterioriknowledge, or knowledge that is based on measurement. Atsome point in the life of the aluminum metal, testing would berequired to quantify the concentrations of lead, cadmium,mercury and hexavalent chromium associated with the alumi-num. I
43、nformation on the lead and cadmium content, as well astotal chromium, may be available in the form of a Certificate ofAnalysis generated by the producer or by an independentlaboratory. If such a document is not available or the availableinformation requires verification, testing of the part is requi
44、redto evaluate conformance to requirements. Aluminum Associa-tion specifications require that aluminum producers maintain asurveillance program for mercury so that production is moni-tored on a periodic (quarterly within North America) basis toensure that mercury has not been introduced into any of
45、theproduction processes. The test method(s) applied to the alumi-num part should be designed specifically for analysis of thesubstances on or within aluminum or aluminum alloys; in otherwords, both the substance sought and the material to beanalyzed should be included in the scope of the test method
46、. Ifa standard method does not exist, it is incumbent upon thelaboratory to demonstrate that the method employed is validfor analysis of the substance in (or on) the specific materialtested.6.1.4 Validation of a method can be accomplished throughanalysis of a reference material, preferably a certifi
47、ed referencematerial with traceability to SI units, using the same method ofanalysis as is used on the unknown sample. The referencematerial used for validation of the method shall be of the sameor similar composition of the unknown sample; for example,the reference material used to validate the ana
48、lysis of alumi-num or its alloys for a substance shall be covered by the scopeof the test method for aluminum and its alloys and shall alsocontain a known concentration of the substance to be mea-sured.NOTE 4Areference material to be used for validation of a test methodshould not also be used for ca
49、libration of the instrument.NOTE 5The instrument used for analysis of the sample is not asimportant as demonstration that the instrument is capable of analyzingsubstances in specific materials; such capability may be demonstratedthrough validation of the test method.6.2 A red piece of polyvinyl chloride (PVC) is to beevaluated for conformance to the requirements of the RoHSDirective. It was established that the PVC sample representedmaterial which would be incorporated into a finished electronicproduct to be sold on the European market after the effectivedate of the RoHS Direct
