ASTM D7850-2018 red 0000 Standard Specification for Biological Properties of Industry Reference Materials (IRM).pdf

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1、Designation: D7850 13D7850 18Standard 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

2、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 specifications or requirements, or both, for Industry Reference Ma

3、terials(IRMs) as cited in Practice D4678 and other standards.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,

4、it must comply with the specifications prescribed in thisspecification. However, these specifications are only part of the requirements. Other requirements as given in Practice D4678 shallbe met before a candidate material can be formally accepted as a biological IRM.1.4 The values stated in SI unit

5、s are to be regarded as standard. No other units of measurement are included in this standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health

6、, and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of Internat

7、ional Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D4678 Practice for RubberPreparation, Testing, Acceptance, Documentation, and Use of Reference MaterialsD5712 Test Method for Analy

8、sis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using theModified Lowry MethodD6499 Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its ProductsD7427 Test Method for Immunological Measurement of Four Principal Allergenic

9、Proteins (Hev b 1, 3, 5 and 6.02) in HeveaNatural Rubber and Its Products Derived from Latex3. Significance and Use3.1 IRMs are vitally important in product and specification testing, in research and development work, in technical service work,and in quality control operations in the rubber and carb

10、on black industries. They are especially valuable for referee purposes. ManyASTM rubber standards for the evaluation of natural or synthetic rubber require the use of specific IRMs for better laboratoryrepeatability and reproducibility.3.2 New material lots that have been selected as candidates for

11、IRM approval shall conform to the appropriate specificationsgiven in this standard and meet requirements given in Practice D4678 before the lots may be accepted as IRMs.3.3 The biological IRM specifications shown will ensure some consistency in IRM properties from one lot to the next. However,the sp

12、ecifications cannot ensure exact inter-lot consistency.1 This test method specification is under the jurisdiction of ASTM Committee D11 on Rubber and Rubber-like Materials and is the direct responsibility of SubcommitteeD11.40 on Consumer Rubber Products.Current edition approved Jan. 1, 2013June 1,

13、2018. Published January 2013July 2018. Originally approved in 2013. Last previous edition approved in 2013 as D7850 13.DOI: 10.1520/D7850-13.10.1520/D7850-18.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of AS

14、TM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically p

15、ossible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700,

16、 West Conshohocken, PA 19428-2959. United States14. Specifications4.1 The following are specifications for the Biological Industry Reference Materials:4.1.1 Specification for IRM 9133Ammoniated Latex Antigenic Protein:4.1.1.1 Material description: Sealed descriptionSealed vial for hypodermic extract

17、ion403 extraction: 200 test quantity.4.1.1.2 Specifications are given in Table 1.4.1.2 Specification for IRM 9143Rabbit Anti AL Antisera:4.1.2.1 Material description: Screw-cap descriptionScrew-cap vials with O-Ring seals301 seals: 200 test quantity.4.1.2.2 Specifications are given in Table 2.4.1.3

18、Specification for IRM 9154Mouse monoclonal antibody Hb1-5:4.1.3.1 Material description: Vials descriptionVials with frozen materialup to 13 400 material: 1000 test quantity.4.1.3.2 Specifications are given in Table 3.4.1.4 Specification for IRM 9164Mouse monoclonal antibody Hb1-1:4.1.4.1 Material de

19、scription: Vials descriptionVials with frozen materialup to 13 400 material: 1000 test quantity.4.1.4.2 Specifications are given in Table 4.4.1.5 Specification for IRM 9174Hev b 1 Reference Protein:4.1.5.1 Material description: Vials descriptionVials with lyophilized materialup to 1000 material: 100

20、0 test quantity.4.1.5.2 Specifications are given in Table 5.4.1.6 Specification for IRM 9184Mouse monoclonal antibody Hb3-5:4.1.6.1 Material description: Vials descriptionVials with frozen materialup to 13 400 material: 1000 test quantity.4.1.6.2 Specifications are given in Table 6.4.1.7 Specificati

21、on for IRM 9194Mouse monoclonal antibody Hb3-10:4.1.7.1 Material description: Vials descriptionVials with frozen materialup to 13 400 material: 1000 test quantity.4.1.7.2 Specifications are given in Table 7.4.1.8 Specification for IRM 9204Hev b 3 Reference Protein:4.1.8.1 Material description: Vials

22、 descriptionVials with lyophilized materialup to 1000 material: 1000 test quantity.4.1.8.2 Specifications are given in Table 8.4.1.9 Specification for IRM 9214Mouse monoclonal antibody Hb5-4:4.1.9.1 Material description: Vials descriptionVials with frozen materialup to 13 400 material: 1000 test qua

23、ntity.4.1.9.2 Specifications are given in Table 9.4.1.10 Specification for IRM 9224Mouse monoclonal antibody Hb5-11:4.1.10.1 Material description: Vials descriptionVials with frozen materialup to 13 400 material: 1000 test quantity.4.1.10.2 Specifications are given in Table 10.4.1.11 Specification f

24、or IRM 9234Hev b 5 Reference Protein:4.1.11.1 Material description: Vials descriptionVials with lyophilized materialup to 1000 material: 1000 test quantity.4.1.11.2 Specifications are given in Table 11.3 An approved lot has been reserved and is available from Akron Rubber Development Lab Inc., 2887

25、Gilchrist Rd., Akron, OH 44305, website: .4 An approved lot, IRM 915 to 924, has been reserved and is available from Scripps Laboratories, 6838 Flanders Drive, San Diego, CA 92121, website:.TABLE 1 Specification for IRM 913Ammoniated Latex AntigenicProteinProperty ASTM Designation Limit/TargetSource

26、 D6499 Ammoniated NR Latex(high and low)Protein Amount D5712 Stock solution shouldbe adjusted to 1 mgprotein per mLAllergen Concentration D7427 Allergen Concentrationof four allergens re-ported per ug total pro-tein as determined byD5712 with and withoutbackground subtractionSDS-PAGE D6499 Full dist

27、ribution of NRproteins (between 5kDa and 200 kDa)Western blot profile D6499 Full distribution of NRantigens (between 5kDa and 200 kDa)Inhibition ELISA D6499 Adjust antigen contentbased on D6499determination.D7850 1824.1.12 Specification for IRM 9244Mouse monoclonal antibody Hb6.02-2:4.1.12.1 Materia

28、l description: Vials descriptionVials with frozen materialup to 13 400 material: 1000 test quantity.4.1.12.2 Specifications are given in Table 12.4.1.13 Specification for IRM 925Mouse monoclonal antibody Hb6.02-N3:4.1.13.1 Material description: Vials descriptionVials with frozen materialup to 13 400

29、 material: 1000 test quantity.TABLE 2 Specification for IRM 914Rabbit Anti-AL AntiseraProperty ASTM Designation Limit/TargetAnimal D6499 RabbitsAntigen D6499 Ammoniated NR refer-ence proteinAdjuvant Titer D6499 Freunds complete andincomplete Minimum1/8000Western blot profileA D6499 Reactivity with e

30、ntirespectrum of SDS-PAGEBvisible AL proteinInhibition ELISAreactivityCD6499 Comparative analysis ofextracts from a minimumof 5 NR productsA Western blot represents the transfer of protein from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.B SDS-PAGE represents sodiu

31、m dodecylsulfate polyacrylamide gelelectrophoresis.C ELISA represents the enzyme linked immuno-sorbant assay.TABLE 3 Specification for IRM 915Mouse monoclonal antibodyHb1-5Property ASTM Designation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb1 proteinAdjuvant D7427 Freunds complete andincom

32、pleteTiter D7427 Minimum 1/4000SDS PAGE Coomassiestain profileAD7427 Two bands detectableWestern blot profileB D7427 Reactivity with FLC andHev b 1 proteinCapture ELISAreactivityDD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsA SDS-PAGE represents sodium dodecylsulfate polyacr

33、ylamide gelelectrophoresis.B Western blot represents the transfer of protein from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.C Natural Hevea Natural Rubber Latex designated as Field Latex.D ELISA represents the enzyme linked immuno-sorbant assay.TABLE 4 Specificat

34、ion for IRM 916Mouse monoclonal antibodyHb1-1Property ASTM Designation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb1 proteinAdjuvant D7427 Freunds complete andincompleteTiter D7427 Minimum 1/3000SDS PAGE Coomassiestain profileAD7427 Two bands detectableWestern blot profileB D7427 Reactivity

35、 with FLC andHev b 1 proteinCapture ELISAreactivityDD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsA SDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.B Western blot represents the transfer of protein from SDS-Page to a membraneand subsequent antigen

36、analysis using NR latex anti-sera.C Natural Hevea Natural Rubber Latex designated as Field Latex.D ELISA represents the enzyme linked immuno-sorbant assay.D7850 1834.1.13.2 Specifications are given in Table 13.4.1.14 Specification for IRM 926Hev b 6.02 Reference Protein:4.1.14.1 Material description

37、: Vials descriptionVials with lyophilized materialup to 1000 material: 1000 test quantity.4.1.14.2 Specifications are given in Table 14.TABLE 5 Specification for IRM 917Hev b 1 Reference ProteinProperty ASTM Designation Limit/TargetSource D7427 r MBP-Hevb1Protein Amount D7427 Stock solution shouldbe

38、 adjusted to 1000ng/mLRP chromatographyprofileD7427 One major peak detect-ableWestern blot profileA D7427 One band detectable atmolecular weight ap-proximately 10 to 15kDaCapture ELISAreactivityBD7427 Adjust antigen contentbased on D7427determinationA Western blot represents the transfer of protein

39、from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.B ELISA represents the enzyme linked immuno-sorbant assay.TABLE 6 Specification for IRM 918Mouse monoclonal antibodyHb3-5Property ASTM Designation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb3 proteinAdjuvan

40、t D7427 Freunds complete andincompleteTiter D7427 Minimum 1/4000SDS PAGE Coomassiestain profileAD7427 Two bands detectableWestern blot profileB D7427 Reactivity with FLC andHev b 3 proteinCapture ELISAreactivityDD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsA SDS-PAGE represe

41、nts sodium dodecylsulfate polyacrylamide gelelectrophoresis.B Western blot represents the transfer of protein from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.C Natural Hevea Natural Rubber Latex designated as Field Latex.D ELISA represents the enzyme linked immuno

42、-sorbant assay.TABLE 7 Specification for IRM 919Mouse monoclonal antibodyHb3-10Property ASTM Designation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb3 proteinAdjuvant D7427 Freunds complete andincompleteTiter D7427 Minimum 1/3000SDS PAGE Coomassiestain profileAD7427 Two bands detectableWest

43、ern blot profileB D7427 Reactivity with FLC andHev b 3 proteinCapture ELISAreactivityDD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsA SDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.B Western blot represents the transfer of protein from SDS-Page to

44、 a membraneand subsequent antigen analysis using NR latex anti-sera.C Natural Hevea Natural Rubber Latex designated as Field Latex.D ELISA represents the enzyme linked immuno-sorbant assay.D7850 1845. Keywords5.1 allergens; biological properties; immunoassays; industry reference materials; IRM; mono

45、clonal antibody; NR latex; rabbitanti AL antiseraTABLE 8 Specification for IRM 920Hev b 3 Reference ProteinProperty ASTM Designation Limit/TargetSource D7427 Field Latex (FL)AProtein Amount D7427 Stock solution shouldbe adjusted to 1000ng/mLRP chromatographyprofileD7427 One major peak detect-ableWes

46、tern blot profileB D7427 One band detectable atmolecular weight ap-proximately 20 to 25kDaCapture ELISAreactivityCD7427 Adjust antigen contentbased on D7427determinationA Natural Hevea Natural Rubber Latex designated as Field Latex.B Western blot represents the transfer of protein from SDS-Page to a

47、 membraneand subsequent antigen analysis using NR latex anti-sera.C ELISA represents the enzyme linked immuno-sorbant assay.TABLE 9 Specification for IRM 921Mouse monoclonal antibodyHb5-4Property ASTM Designation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb5 proteinAdjuvant D7427 Freunds co

48、mplete andincompleteTiter D7427 Minimum 1/3000SDS PAGE Coomassiestain profileAD7427 Two bands detectableCapture ELISAreactivityBD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsA SDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.B ELISA represents the e

49、nzyme linked immuno-sorbant assay.TABLE 10 Specification for IRM 922Mouse monoclonalantibody Hb5-11Property ASTM Designation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb5 proteinAdjuvant D7427 Freunds complete andincompleteTiter D7427 Minimum 1/3000SDS PAGE Coomassiestain profileAD7427 Two bands detectableCapture ELISAreactivityBD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsA SDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.B EL