ASTM_D_7850_-_19.pdf

Designation:D785019Standard 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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.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 Latex,Natural Rubber,and Elastomeric Prod-ucts Using the Modified Lowry MethodD6499 Test Method for Immunological Measurement ofAntigenic Protein in Hevea Natural Rubber(HNR)and itsProductsD7427 Test Method for Immunological Measurement ofFour PrincipalAllergenic Proteins(Hev b 1,3,5 and 6.02)in Hevea Natural Rubber and Its Products Derived fromLatexD8238 Test Method for Immunological Assay to QuantifyExtractable Guayule Natural Rubber(GNR)Proteins3.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 descriptionSealed vial for hypodermicextraction:200 test quantity.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved Nov.1,2019.Published December 2019.Originallyapproved in 2013.Last previous edition approved in 2018 as D7850 18.DOI:10.1520/D7850-19.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 4.1.1.2 Specifications are given in Table 1.4.1.2 Specification for IRM 9143Rabbit Anti AHNRLAntisera:4.1.2.1 Material descriptionScrew-cap vials with O-Ringseals:200 test quantity.4.1.2.2 Specifications are given