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Product Code:SAE AIR4289
Title:Handbook for the SAE As4075 High Speed Ring Bus Standard
Issuing Committee:As-1a Avionic Networks Committee
Scope: This Handbook has been prepared by the Ring Implementation Task Group of the SAE AS-2 Committee, and is intended to support AS4075 by providing explanation of the standard itself and guidance on its use. The principal objective in the preparation of a standard is to provide a statement of operational and performance requirements, and an unambiguous definition of the functions to be realized in any implementation, primarily from the view point of interoperability. While efforts have been made within the AS4075 standard to provide a readable general description of the HSRB, detailed explanations, rationale and guidance to the use are incompatible with the purpose and, indeed, the format of a standard. Accordingly, this Handbook contains a paragraph-by-paragraph explanation of the main sections of the standard, and a discussion of application and implementation issues.【英文标准名称】:StandardTestMethodforImmunologicalMeasurementofFourPrincipalAllergenicProteins(Hevb1,3,5and6.02)inNaturalRubberandItsProductsDerivedfromLatex
【原文标准名称】:天然橡胶及其胶乳衍生物中4种主要过敏蛋白质(Hevb1,3,5和6.02)免疫学测量的试验方法
【标准号】:ASTMD7427-2008e1
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:D11.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:过敏原
【英文主题词】:allergens;Heveabrasiliensis;IEMA;immunoenzymetricassay;naturalrubberlatex;proteins;Allergens;Naturalrubber(NR);Naturalrubber(NR)latex;Proteins
【摘要】:IgE-mediatedallergicreactionstoproteinallergensinnaturalrubberlatexderivedfromtheHeveabrasiliensistreeemergedinthe1990sasaconcernwithoccasionalallergicmanifestations.Symptomsencompassinghives,uriticaria,rhinitis,asthmaandanaphylaxishaveallbeenreportedinlatexallergicindividualsexposedtoproductsderivedfromnaturalrubberlatex.SincenosafelevelofHevealatexallergenexposureisknown,avoidanceistheprimarymodeoftreatinglatexallergy.Asaresultofinvestigationsconductedbymanyscientistsacrosstheworld,thirteenlatexallergenshavesofarbeenidentifiedandcategorizedbytheAllergenNomenclatureSub-CommitteeoftheInternationalUnionofImmunologicalSocieties(IUIS)asHevb1toHevb13(Table1)(seeSpecificationD1193).ReportedsensitizationratesfortheseallergenicHevbproteinsvaryamongthemanyreportsasaresultofdifferencesinthestudypopulations,IgEantibodyassaymethodsandthequalityoftheHevballergensusedascalibratorsandqualitycontrolreagentsintheanalysis.Moststudies,however,agreethatHevb1andHevb3areimportantallergensforindividuals(forexample,childrenwithspinabifida)whoareexposedthroughmucosalcontactasaresultofmultiplesurgeriesorlatexcatheteruseforanextendedperiodoftime.Additionally,investigatorsperformingsensitizationstudiesalsoagreethatHevb5andHevb6.02areimportantallergensthatmayelicitsensitizationingenetically-predisposedindividualswhoareexposedtonaturalrubberlatex(2-4).Onthebasisoftheseclinicalstudies,assaysforthesefourallergenicproteins(thatis,Hevb1,Hevb3,Hevb5andHevb6.02)havebeendevelopedandtheyarethusthesubjectofthisstandard.Adoptionofimmunoenzymetricassayreagentsandstandardproteinsneededtoquantifyotherlatexallergens(otherthanHevb1,3,5,and6.02)inextractsofnaturalrubberlatexproductswillrequireseparatedocumentationandvalidation.1.1Thistestmethodcoversanimmunologicalmethodknownasanimmunoenzymetricassaytoquantifytheamountof4principalHeveabrasiliensis[Hevb]allergenicproteins[Hevb1,Hevb3,Hevb5andHevb6.02]innaturalrubberanditsproductsderivedfromlatexusingmonoclonalantibodiesspecificforepitopesontheseproteins.Sincetheseassaysquantifythelevelsofonly4oftheknown13officiallyacknowledgedallergenspotentiallypresentinnaturalrubberlatexcontainingproducts,thesumofthefourallergenlevelsshallbeviewedasanindicatoroftheallergenburdenandnotasameasureofthetotalallergencontentthatcanbereleasedfromtheproduct.1.2Forthepurposeofthistestmethod,therangeofallergenicproteinwillbemeasuredintermsofnanogramtomicrogramquantitiespergramorunitsurfaceareaofanaturalrubbercontainingproduct.1.3ThetestmethodisnotdesignedtoevaluatethepotentialofnaturalrubbercontainingmaterialstoinduceorelicitTypeI(IgE-mediated)hypersensitivityreactions.1.4Thistestmethodshouldbeusedundercontrolledlaboratoryconditionstodetectandquantifythelevelof4allergenicproteinsfoundinnaturalrubbercontainingproducts.Itshouldnotbeusedtodescribe,appraiseorassessthehazardorriskofthesenaturalrubbercontainingmaterialsorproductsunderactualinuseconditions.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Iti......
【中国标准分类号】:B72
【国际标准分类号】:83_060
【页数】:16P.;A4
【正文语种】:英语