ASTM D7850-2013 1875 Standard Specification for Biological Properties of Industry Reference Materials (IRM)《工业参考材料 (IRM) 的生物学特性的标准规范》.pdf

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1、Designation: D7850 13Standard 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

2、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

3、(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

4、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 b

5、e 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 d

6、etermine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D4678 Practice for RubberPreparation, Testing,Acceptance, Documentation, and Use of Reference Mate-rialsD5712 Test Method for Analysis of Aqueous ExtractableProtein in Natural Rubber and Its

7、 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 fro

8、m 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

9、 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 an

10、d 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 follow

11、ing 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 9143Ra

12、bbit Anti ALAntisera: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 te

13、st 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.

14、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

15、, 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 States14.1.3.2 Specifi

16、cations 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 Material desc

17、ription: Vials with lyophilizedmaterialup 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 are given in Table 6.4

18、.1.7 Specification for IRM 9194Mouse monoclonal anti-body Hb3-10:4.1.7.1 Material description: Vials with frozen materialupto 13 400 test quantity.4.1.7.2 Specifications are given in Table 7.4.1.8 Specification for IRM 9204Hev b 3 Reference Pro-tein:4.1.8.1 Material description: Vials with lyophiliz

19、edmaterialup to 1000 test quantity.4.1.8.2 Specifications are given in Table 8.4.1.9 Specification for IRM 9214Mouse monoclonal anti-body Hb5-4:4.1.9.1 Material description: Vials with frozen materialupto 13 400 test quantity.4.1.9.2 Specifications are given in Table 9.4.1.10 Specification for IRM 9

20、224Mouse monoclonal an-tibody Hb5-11:4.1.10.1 Material description: Vials with frozenmaterialup to 13 400 test quantity.4.1.10.2 Specifications are given in Table 10.4.1.11 Specification for IRM 9234Hev b 5 ReferenceProtein:4.1.11.1 Material description: Vials with lyophilizedmaterialup to 1000 test

21、 quantity.4.1.11.2 Specifications are given in Table 11.4.1.12 Specification for IRM 9244Mouse monoclonal an-tibody Hb6.02-2:TABLE 1 Specification for IRM 913Ammoniated Latex AntigenicProteinProperty ASTM Designation Limit/TargetSource D6499 Ammoniated NR Latex(high and low)Protein Amount D5712 Stoc

22、k 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 distribution of NRproteins (between 5kDa and 200 kDa)Western blot pro

23、file D6499 Full distribution of NRantigens (between 5kDa and 200 kDa)Inhibition ELISA D6499 Adjust antigen contentbased on D6499determination.TABLE 2 Specification for IRM 914Rabbit Anti-AL AntiseraProperty ASTM Designation Limit/TargetAnimal D6499 RabbitsAntigen D6499 Ammoniated NR refer-ence prote

24、inAdjuvant Titer D6499 Freunds complete andincomplete Minimum1/8000Western blot profileAD6499 Reactivity with entirespectrum of SDS-PAGEBvisible AL proteinInhibition ELISAreactivityCD6499 Comparative analysis ofextracts from a minimumof 5 NR productsAWestern blot represents the transfer of protein f

25、rom SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.BSDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.CELISA represents the enzyme linked immuno-sorbant assay.TABLE 3 Specification for IRM 915Mouse monoclonal antibodyHb1-5Property ASTM Design

26、ation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb1 proteinAdjuvant D7427 Freunds complete andincompleteTiter D7427 Minimum 1/4000SDS PAGE Coomassiestain profileAD7427 Two bands detectableWestern blot profileBD7427 Reactivity with FLCandHevb1proteinCapture ELISAreactivityDD7427 Comparative

27、analysis ofextracts from a mini-mum of 5 NR productsASDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.BWestern blot represents the transfer of protein from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.CNatural Rubber Latex designated as Fi

28、eld Latex.DELISA represents the enzyme linked immuno-sorbant assay.TABLE 4 Specification 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 Co

29、omassiestain profileAD7427 Two bands detectableWestern blot profileBD7427 Reactivity with FLCandHevb1proteinCapture ELISAreactivityDD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsASDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.BWestern blot represe

30、nts the transfer of protein from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.CNatural Rubber Latex designated as Field Latex.DELISA represents the enzyme linked immuno-sorbant assay.D7850 1324.1.12.1 Material description: Vials with frozenmaterialup to 13 400 test

31、quantity.4.1.12.2 Specifications are given in Table 12.4.1.13 Specification for IRM 925Mouse monoclonal anti-body Hb6.02-N3:4.1.13.1 Material description: Vials with frozenmaterialup to 13 400 test quantity.4.1.13.2 Specifications are given in Table 13.4.1.14 Specification for IRM 926Hev b 6.02 Refe

32、renceProtein:4.1.14.1 Material description: Vials with lyophilizedmaterialup to 1000 test quantity.4.1.14.2 Specifications are given in Table 14.5. Keywords5.1 allergens; biological properties; immunoassays; industryreference materials; IRM; monoclonal antibody; NR latexrab-bit anti AL antiseraTABLE

33、 5 Specification for IRM 917Hev b 1 Reference ProteinProperty ASTM Designation Limit/TargetSource D7427 r MBP-Hevb1Protein Amount D7427 Stock solution shouldbe adjusted to 1000ng/mLRP chromatographyprofileD7427 One major peak detect-ableWestern blot profileAD7427 One band detectable atmolecular weig

34、ht ap-proximately 10 to 15kDaCapture ELISAreactivityBD7427 Adjust antigen contentbased on D7427determinationAWestern blot represents the transfer of protein from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.BELISA represents the enzyme linked immuno-sorbant assay.TA

35、BLE 6 Specification for IRM 918Mouse monoclonal antibodyHb3-5Property ASTM Designation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb3 proteinAdjuvant D7427 Freunds complete andincompleteTiter D7427 Minimum 1/4000SDS PAGE Coomassiestain profileAD7427 Two bands detectableWestern blot profileBD

36、7427 Reactivity with FLCandHevb3proteinCapture ELISAreactivityDD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsASDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.BWestern blot represents the transfer of protein from SDS-Page to a membraneand subsequent

37、 antigen analysis using NR latex anti-sera.CNatural Rubber Latex designated as Field Latex.DELISA represents the enzyme linked immuno-sorbant assay.TABLE 7 Specification for IRM 919Mouse monoclonal antibodyHb3-10Property ASTM Designation Limit/TargetAnimal D7427 MouseAntigen D7427 rMBP-Hevb3 protein

38、Adjuvant D7427 Freunds complete andincompleteTiter D7427 Minimum 1/3000SDS PAGE Coomassiestain profileAD7427 Two bands detectableWestern blot profileBD7427 Reactivity with FLCandHevb3proteinCapture ELISAreactivityDD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsASDS-PAGE repres

39、ents sodium dodecylsulfate polyacrylamide gelelectrophoresis.BWestern blot represents the transfer of protein from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.CNatural Rubber Latex designated as Field Latex.DELISA represents the enzyme linked immuno-sorbant assay.T

40、ABLE 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-ableWestern blot profileBD7427 One band detectable atmole

41、cular weight ap-proximately 20 to 25kDaCapture ELISAreactivityCD7427 Adjust antigen contentbased on D7427determinationANatural Rubber Latex designated as Field Latex.BWestern blot represents the transfer of protein from SDS-Page to a membraneand subsequent antigen analysis using NR latex anti-sera.C

42、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 complete andincompleteTiter D7427 Minimum 1/3000SDS PAGE Coomassiestai

43、n profileAD7427 Two bands detectableCapture ELISAreactivityBD7427 Comparative analysis ofextracts from a mini-mum of 5 NR productsASDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.BELISA represents the enzyme linked immuno-sorbant assay.TABLE 10 Specification for IRM 922Mo

44、use 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 ofe

45、xtracts from a mini-mum of 5 NR productsASDS-PAGE represents sodium dodecylsulfate polyacrylamide gelelectrophoresis.BELISA represents the enzyme linked immuno-sorbant assay.D7850 133ASTM International takes no position respecting the validity of any patent rights asserted in connection with any ite

46、m mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical comm

47、ittee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a m

48、eeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive

49、, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).TABLE 11 Specification for IRM 923Hev b 5 Reference ProteinProperty ASTM Designation Limit/TargetSource D74