【英文标准名称】:StandardPracticeforSelectingGenericBiologicalTestMethodsforMaterialsandDevices
【原文标准名称】:材料和装置用一般生物试验方法的选择的标准实施规程
【标准号】:ASTMF748-2006(2010)
【标准状态】:现行
【国别】:美国
【发布日期】:2006
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:animaltesting;biocompatibility;invivotesting;laboratorytesting;toxicity;Biocompatibility
【摘要】:Theobjectiveofthispracticeistorecommendsufficientbiologicaltestingtoestablishareasonablelevelofconfidenceconcerningthebiologicalresponsetoamaterialordevice,whileatthesametimeavoidingunnecessarytesting.Thispracticeisintendedtoprovideguidancetothematerialsinvestigatorinselectingtheproperprocedurestobecarriedoutforthescreeningofnewormodifiedmaterials.Becauseeachmaterialandeachimplantsituationinvolvesitsownuniquecircumstances,theserecommendationsshouldbemodifiedasnecessaryanddonotconstitutetheonlytestingthatwillberequiredforamaterialnorshouldtheseguidelinesbeinterpretedasminimumrequirementsforanyparticularsituation.Whileanattempthasbeenmadetoproviderecommendationfordifferentimplantcircumstances,someoftherecommendedtestingmaynotbenecessaryorreasonableforaspecificmaterialorapplication.1.1Thispracticerecommendsgenericbiologicaltestmethodsformaterialsanddevicesaccordingtoend-useapplications.Whilechemicaltestingforextractableadditivesandresidualmonomersorresiduesfromprocessingaidsisnecessaryformostimplantmaterials,suchtestingisnotincludedaspartofthispractice.Thereaderiscautionedthattheareaofmaterialsbiocompatibilitytestingisarapidlyevolvingfield,andimprovedmethodsareevolvingrapidly,sothispracticeisbynecessityonlyaguideline.Athoroughknowledgeofcurrenttechniquesandresearchiscriticaltoacompleteevaluationofnewmaterials.1.2Thesetestprotocolsareintendedtoapplytomaterialsandmedicaldevicesforhumanapplication.Biologicalevaluationofmaterialsanddevices,andrelatedsubjectssuchaspyrogentesting,batchtestingofproductionlots,andsoon,arealsodiscussed.Testsincludethoseperformedonmaterials,endproducts,andextracts.Rationaleandcommentsoncurrentstateoftheartareincludedforalltestproceduresdescribed.1.3Thebiocompatibilityofmaterialsusedinsingleormulticomponentmedicaldevicesforhumanusedependstoalargedegreeontheparticularnatureoftheend-useapplication.Biologicalreactionsthataredetrimentaltothesuccessofamaterialinonedeviceapplicationmayhavelittleornobearingonthesuccessfuluseofthematerialforadifferentapplication.Itis,therefore,notpossibletospecifyasetofbiocompatibilitytestmethodswhichwillbenecessaryandsufficienttoestablishbiocompatibilityforallmaterialsandapplications.1.4Theevaluationoftissueengineeredmedicalproducts(TEMPs)may,insomecases,involvedifferentoradditionaltestingbeyondthosesuggestedfornon-tissue-basedmaterialsanddevices.Whereappropriate,thesedifferencesarediscussedinthispracticeandadditionaltestsdescribed.1.5Theethicaluseofresearchanimalsplacestheobligationontheindividualinvestigatortodeterminethemostefficientmethodsforperformingthenecessarytestingwithoutundueuseofanimals.Whereadequatepriordataexiststosubstantiatecertaintypesofsafetyinformation,theseguidelinesshouldnotbeinterpretedtomeanthattestingshouldbeunnecessarilyrepeated.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A40
【国际标准分类号】:07_080
【页数】:8P.;A4
【正文语种】:英语