ASTM_D_7850_-_13.pdf

Designation:D785013Standard Specification forBiological Properties of Industry Reference Materials(IRM)1This standard is issued under the fixed designation D7850;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.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 specification covers the biological quality specifi-cations or requirements,or both,for Industry ReferenceMaterials(IRMs)as cited in Practice D4678 and other stan-dards.1.2 IRMs,as evaluated and referenced in Practice D4678,are vitally important to conduct product,specification,anddevelopment testing in the rubber and carbon black industries.1.3 Before a new lot of material can be accepted as an IRM,it must comply with the specifications prescribed in thisspecification.However,these specifications are only part of therequirements.Other requirements as given in Practice D4678shall be met before a candidate material can be formallyaccepted as a biological IRM.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 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 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D4678 PracticeforRubberPreparation,Testing,Acceptance,Documentation,and Use of Reference Mate-rialsD5712 Test Method for Analysis of Aqueous ExtractableProtein in Natural Rubber and Its Products Using theModified Lowry MethodD6499 Test Method for The Immunological Measurement ofAntigenic Protein in Natural Rubber and its ProductsD7427 Test Method for Immunological Measurement ofFour PrincipalAllergenic Proteins(Hev b 1,3,5 and 6.02)in Natural Rubber and Its Products Derived from Latex3.Significance and Use3.1 IRMs are vitally important in product and specificationtesting,in research and development work,in technical servicework,and in quality control operations in the rubber andcarbon black industries.They are especially valuable forreferee purposes.Many ASTM rubber standards for the evalu-ation of natural or synthetic rubber require the use of specificIRMs for better laboratory repeatability and reproducibility.3.2 New material lots that have been selected as candidatesfor IRM approval shall conform to the appropriate specifica-tions given in this standard and meet requirements given inPractice D4678 before the lots may be accepted as IRMs.3.3 The biological IRM specifications shown will ensuresome consistency in IRM properties from one lot to the next.However,the specifications cannot ensure exact inter-lot con-sistency.4.Specifications4.1 The following are specifications for the BiologicalIndustry Reference Materials:4.1.1 Specification for IRM 9133Ammoniated Latex An-tigenic Protein:4.1.1.1 Material description:Sealed vial for hypodermicextraction403 test quantity.4.1.1.2 Specifications are given in Table 1.4.1.2 Specification for IRM 9143RabbitAntiALAntisera:4.1.2.1 Material description:Screw-cap vials with O-Ringseals301 test quantity.4.1.2.2 Specifications are given in Table 2.4.1.3 Specification for IRM 9154Mouse monoclonal anti-body Hb1-5:4.1.3.1 Material description:Vials with frozen materialupto 13 400 test quantity.1This test method is under the jurisdiction of ASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Jan.1,2013.Published January 2013.DOI:10.1520/D7850-13.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3An approved lot has been reserved and is available from Akron RubberDevelopment Lab Inc.,2887 Gilchrist Rd.,Akron,OH 44305,website:www.ardl-.com.4An approved lot,IRM 915 to 924,has been reserved and is available fromScripps Laboratories,6838 Flanders Drive,San Diego,CA 92121,website:.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.1.3.2 Specifications are given in Table 3.4.1.4 Specification for IRM 9164Mouse monoclonal anti-body Hb1-1:4.1.4.1 Material description:Vials with frozen materialupto 13 400 test quantity.4.1.4.2 Specifications are given in Table 4.4.1.5 Specification for IRM 9174Hev b 1 Reference Pro-tein:4.1.5.1 Materialdescription:Vialswithlyophilizedmaterialup to 1000 test quantity.4.1.5.2 Specifications are given in Table 5.4.1.6 Specification for IRM 9184Mouse monoclonal anti-body Hb3-5:4.1.6.1 Material description:Vials with frozen materialupto 13 400 test quantity.4.1.6.2 Specifications