ASTM F2577-2006 Standard Guide for Assessment of Materials and Products for Declarable Substances《应申报物质材料和产品的评估标准指导》.pdf

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1、Designation: F 2577 06Standard Guide forAssessment of Materials and Products for DeclarableSubstances1This standard is issued under the fixed designation F 2577; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revi

2、sion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 whe

3、n evaluating 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 standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibilit

4、y of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F 2576 Terminology Relating to Declarable Substances inMaterials2.2 Other Documents:DTI ROHS Regulat

5、ions Government Guidance Notes,November 2005, SI 2005 No. 27483European Commission Decision 2005/618/EC CommissionDecision of 18 August 2005 amending Directive 2002/95/EC of the European Parliament and of the Council forthe purpose of establishing the maximum concentrationvalues for certain hazardou

6、s substances in electrical andelectronic equipment4European Union Directive 2002/95/EC on the Restriction ofthe Use of Certain Hazardous Substances in Electrical andElectronic Equipment5European Union Directive 2002/96/EC on Waste Electricaland Electronic Equipment63. Terminology3.1 Terms and defini

7、tions related to declarable substances inmaterials may be found in Terminology F 2576.3.2 Terms and definitions in the guide not found in Termi-nology F 2576 may be found in a common dictionary or otherreference documents such as the ASTM Dictionary of Engi-neering Science notified underdocument num

8、ber C(2005) 3143.5Official Journal of the European Union, L 37/19, 13.2.2003.6Official Journal of the European Union, L 37/24, 13.2.2003.7Sponsored by ASTM Committee E02 on Terminology; available from ASTMInternational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959; ASTM Stock

9、Number: DEF00.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.effective 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

10、 be a matterof agreement.4.6 Assessment of plastics for presence of declarable sub-stances is more complex than assessment of metals and alloys,since the possible ingredients are comparatively much morenumerous in plastic manufacture.4.7 This guide includes a general process and case studies inorder

11、 to provide guidance and to distinguish where a priori anda posteriori knowledge should be applied. Flow charts as aguide for assessment of materials and products are provided inAppendix X1.5. General Process of Assessment of Materials andProducts for Conformance with Requirements5.1 The process of

12、assessing materials and products forconformance with requirements may be broken down into thefollowing steps:5.1.1 Determine if the material 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

13、limits forsubstances given in the requirements apply.5.1.2.1 List each material to be assessed and assess each onan individual basis.5.1.3 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

14、As necessary, obtain a posteriori knowledge of sub-stance concentrations based upon observations or empiricaldata from the material.5.1.5 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

15、 is eachmaterial within a product, assess each material separately fordeclarable substances content.5.1.5.2 If the basis of conformance to requirements is theentire product, assess the cumulative contribution of declarablesubstances in materials for the entire product5.1.6 Document the assessment pr

16、ocess for each material orproduct.5.2 Determine if the material or product is covered underthe scope of the requirements, taking into account 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 an

17、y assessment is to determinewhat is covered by requirements, or the scope of the require-ments. In some cases exemptions to the scope are 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

18、.5.3 Establish the basis of conformance to which limits forsubstances given in the requirements apply. Requirements inthe form of substance restrictions or declaration limits typicallylist concentrations of substances above which the product ormaterial is considered non-conforming or the substances

19、mustbe declared. It is important to determine the basis to which thelimits apply in order to properly assess conformance. Forexample, the 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 “prod-ucts s

20、hall not contain” certain substances are indeterminate. Products ormaterials cannot be assessed to such limits without accounting for andidentifying every atom constituting the product or material being assessed.5.4 If appropriate, apply a priori knowledge of the materialand its manufacture to asses

21、s the probability whether eachdeclarable substance may be present. Lists of declarablesubstances in requirements may have been set with little or noregard to material types to be assessed. Through application ofa priori knowledge of specific materials it may be possible toeliminate the need to gathe

22、r empirical data for certain sub-stances listed in the requirements.NOTE 2A priori knowledge requires justification based upon scien-tific principles and logical deduction. For example, the statement that it isnot necessary to determine the hexavalent chromium concentration withinwrought metals is b

23、ased upon knowledge of metallurgy and atomicstructure.5.5 As necessary, obtain a posteriori knowledge of sub-stance concentrations based upon observations or empiricaldata from the material. Data on substance concentrationswithin or on materials may be obtained from suppliers in theform of Certifica

24、tes of Analysis or a laboratory report of a lot,batch or heat of material. While it is not necessary to confirmeach and every certificate obtained from suppliers via repeti-tion of testing, it is good practice to periodically confirmmaterial data.5.6 Assess the material or product for conformance to

25、requirements based upon a priori and a posteriori information.The concentrations of any declarable substances in materials orproducts are compared to the limits set by the requirements inorder to determine conformance or non-conformance. While aposteriori information in the form of empirical data ma

26、y bedirectly compared to limit values, a priori information mayindicate that it is not appropriate to assess conformity ofmaterials for certain substances.NOTE 3A priori knowledge that a substance cannot be present in amaterial precludes the possibility of generating empirical data for thatsubstance

27、 within that material. It is appropriate to state in such cases thatconformity assessment is not applicable.5.7 Document the assessment process for each material orproduct. Documentation in the form of data and illustration ofthe assessment process is necessary to back up statements ofcompliance for

28、 materials and products6. Case Studies6.1 A finished aluminum part is to be evaluated for con-formance to the requirements of European Union Directive2002/95/EC on the Restriction of the Use of Certain HazardousSubstances in Electrical and Electronic Equipment (RoHS). Itwas established that the part

29、 would be incorporated into afinished electrical product to be sold on the European marketafter the effective date of the RoHS Directive and the finishedproduct fits the description of electrical products to be regu-lated per the RoHS Directive and European Union Directive2002/96/EC on Waste Electri

30、cal and Electronic Equipment(WEEE).F 2577 0626.1.1 The chemical requirements of the RoHS Directive aregiven in European Commission Decision 2005/618/EC asfollows: the Maximum Concentration Value (MCV) for lead,mercury, hexavalent chromium, polybrominated biphenyls(PBB) and polybrominated diphenyl et

31、hers (PBDE) is 0.1% byweight per homogeneous material and the MCV for cadmiumis 0.01% by weight per homogeneous material. 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

32、aluminum part.6.1.2 A priori knowledge of aluminum and its method ofmanufacture were used to evaluate the part. Aluminum 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 ty

33、pical alumi-num smelter is maintained at 920C 980C at which organicsubstances such as PBB or PBDE are decomposed and becomevolatile 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 them

34、etallic state with an atomic valence of zero. With regard tometals, hexavalent chromium is not found within the metal 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

35、-mium compounds have been employed as pigments in suchmaterials. Lead may be found in some free machining alumi-num alloys 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 th

36、is time. Mercury is volatile and is not likely to befound in aluminum or its alloys, though there are someformulations 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 ox

37、ide, so a piece of solid aluminum is unlikelyto contain more than 0.1% mercury.6.1.3 Application of a priori knowledge of aluminum andits manufacture results in a preliminary assessment concerningthe presence of certain substances. The preliminary assessmentof the aluminum part to the requirements o

38、f RoHS points towhich substances should be measured and which should not:there is a good probability that cadmium or lead 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

39、the part.Conversely, there is low probability that PBB or PBDE arepresent in the aluminum. Completing the evaluation of 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 bereq

40、uired to quantify the concentrations of lead, cadmium,mercury and hexavalent chromium associated with the alumi-num. Information 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 independentlaborator

41、y. If such a document is not available or the availableinformation requires verification, testing of the part is requiredto evaluate conformance to requirements. Aluminum Associa-tion specifications require that aluminum producers maintain asurveillance program for mercury so that production is moni

42、-tored on a periodic (quarterly within North America) basis toensure that mercury has not been introduced into any of 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 o

43、therwords, both the substance sought and the material to beanalyzed should be included in the scope of the test method. 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 materia

44、ltested.6.1.4 Validation of a method can be accomplished throughanalysis of a reference material, preferably a certified 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 b

45、e of the sameor similar composition of the unknown sample; for example,the reference material used to validate the analysis 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 substa

46、nce to be mea-sured.NOTE 4Areference material to be used for validation of a test methodshould not also be used for calibration 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

47、 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 f

48、inished electronicproduct to be sold on the European market after the effectivedate of the RoHS Directive. The finished product fits thedescription of electronic products to be regulated per the RoHSand WEEE Directives.6.2.1 Exemptions to RoHS Directive requirements includethe use of decaBDE (a PBDE

49、 congener) and other brominatedflame retardants not classified as PBB or PBDE and nototherwise regulated by European law. No other exemptionswere applicable to the red PVC sample.6.2.2 Application of a priori knowledge of PVC and itsmanufacture results in a preliminary risk assessment concern-ing the presence of certain substances. The sample was coloredred, indicating that a colorant was used in the formulation.Pigments red in color which have been used in plasticmanufacture include lead, cadmium, mercury and hexavalentchromium compounds. Lead and cadmium have also been usedas