ASTM F1983-1999(2003) 植入用可吸收和再吸收的生物材料的兼容性评定的标准操作规程
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【英文标准名称】:StandardPracticeforAssessmentofCompatibiltiyofAbsorbable/ResorbableBiomaterialsforImplantApplications
【原文标准名称】:植入用可吸收和再吸收的生物材料的兼容性评定的标准操作规程
【标准号】:ASTMF1983-1999(2003)
【标准状态】:现行
【国别】:
【发布日期】:1999
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:可吸收的;生物配伍;可裂变的;植入;可再吸收的
【英文主题词】:absorbables;biocompatibility;degradables;implantation;resorbables;
【摘要】:Thispracticeisaguidelineforascreeningtestfortheevaluationofthelocaltissueresponsetomaterialsthatmaybeselectedforimplantationintothehumanbodyandwhichareexpectedtoundergodegradationbyabsorptionorresorptionwithinthreeyears.Thispracticeissimilartothatforstudiesoncandidatematerialsthatarenotresorbable,suchasthosespecifiedinPracticesF763,F981,andF1408;however,analysisofthehostresponsemusttakeintoaccounttheeffectofdegradationanddegradationproductsontheinflammatoryresponseatthelocaltissuesiteandonsubsequenthealingoftheimplantationsite.Thematerialtobetestedshouldbeinthefinalfinishedformasforintendeduse,includingsterilization.Material/bodyratiosshouldberelevanttothatofintendeddeviceuse.Materialsurfaceareaormasstobodymassratiosof1X,10X,and50Xifapplicable,arerecommended.Materialsthataredesignedforuseindeviceswithinsitupolymerizationshallbeintroducedinamannersuchthatinsitupolymerizationoccurs.Testingofindividualprecursorcomponentsisnotrecommended.1.1Thispracticeprovidesexperimentalprotocolsforbiologicalassaysoftissuereactionstoabsorbable/resorbablebiomaterialsforimplantapplications.Thispracticeappliesonlytoresorbable/absorbablematerialswithprojectedclinicalapplicationsinwhichthematerialswillresideinboneorsofttissuelongerthan30daysandlessthanthreeyears.Otherstandardswithdesignatedimplantationtimesareavailabletoaddresstheshortertimeperiods.Carefulconsiderationshouldbegiventotheappropriatenessofthispracticeforslowlydegradingmaterialsthatwillremainforlongerthanthreeyears.Itisanticipatedthatthetissueresponsetodegradingbiomaterialswillbedifferentfromtheresponsetononresorbablematerials.Inmanycases,achronicinflammatoryresponsemaybeobservedduringthedegradationphase,butthelocalhistologyshouldreturntonormalafterdegradation;therefore,theminimaltissueresponseusuallyequatedwith"biocompatibility"mayrequirelongimplantations.1.2Thetimeperiodforimplantdegradationwillvarydependingonchemicalcompositionandimplantsize;therefore,theimplantationtimesforexaminationoftissueresponsewillbelinkedtotherateofresorption.Nosingleimplantationtimeisindicatedinthispractice.1.3Theseprotocolsassesstheeffectsofthematerialontheanimaltissueinwhichitisimplanted.Theexperimentalprotocolsdonotfullyassesssystemictoxicity,carcinogenicity,teratogenicity,ormutagenicityofthematerial.Otherstandardsareavailabletoaddresstheseissues.1.4Tomaximizeuseoftheanimalsinthestudyprotocol,alltoxicologicalfindingsshouldberecorded.Therearesomeaspectsofsystemictoxicity,includingeffectsofdegradationproductsonthetargetorgans,thatcanbeaddressedwiththispractice,andtheseeffectsshouldbedocumentedfully.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:
【原文标准名称】:植入用可吸收和再吸收的生物材料的兼容性评定的标准操作规程
【标准号】:ASTMF1983-1999(2003)
【标准状态】:现行
【国别】:
【发布日期】:1999
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:可吸收的;生物配伍;可裂变的;植入;可再吸收的
【英文主题词】:absorbables;biocompatibility;degradables;implantation;resorbables;
【摘要】:Thispracticeisaguidelineforascreeningtestfortheevaluationofthelocaltissueresponsetomaterialsthatmaybeselectedforimplantationintothehumanbodyandwhichareexpectedtoundergodegradationbyabsorptionorresorptionwithinthreeyears.Thispracticeissimilartothatforstudiesoncandidatematerialsthatarenotresorbable,suchasthosespecifiedinPracticesF763,F981,andF1408;however,analysisofthehostresponsemusttakeintoaccounttheeffectofdegradationanddegradationproductsontheinflammatoryresponseatthelocaltissuesiteandonsubsequenthealingoftheimplantationsite.Thematerialtobetestedshouldbeinthefinalfinishedformasforintendeduse,includingsterilization.Material/bodyratiosshouldberelevanttothatofintendeddeviceuse.Materialsurfaceareaormasstobodymassratiosof1X,10X,and50Xifapplicable,arerecommended.Materialsthataredesignedforuseindeviceswithinsitupolymerizationshallbeintroducedinamannersuchthatinsitupolymerizationoccurs.Testingofindividualprecursorcomponentsisnotrecommended.1.1Thispracticeprovidesexperimentalprotocolsforbiologicalassaysoftissuereactionstoabsorbable/resorbablebiomaterialsforimplantapplications.Thispracticeappliesonlytoresorbable/absorbablematerialswithprojectedclinicalapplicationsinwhichthematerialswillresideinboneorsofttissuelongerthan30daysandlessthanthreeyears.Otherstandardswithdesignatedimplantationtimesareavailabletoaddresstheshortertimeperiods.Carefulconsiderationshouldbegiventotheappropriatenessofthispracticeforslowlydegradingmaterialsthatwillremainforlongerthanthreeyears.Itisanticipatedthatthetissueresponsetodegradingbiomaterialswillbedifferentfromtheresponsetononresorbablematerials.Inmanycases,achronicinflammatoryresponsemaybeobservedduringthedegradationphase,butthelocalhistologyshouldreturntonormalafterdegradation;therefore,theminimaltissueresponseusuallyequatedwith"biocompatibility"mayrequirelongimplantations.1.2Thetimeperiodforimplantdegradationwillvarydependingonchemicalcompositionandimplantsize;therefore,theimplantationtimesforexaminationoftissueresponsewillbelinkedtotherateofresorption.Nosingleimplantationtimeisindicatedinthispractice.1.3Theseprotocolsassesstheeffectsofthematerialontheanimaltissueinwhichitisimplanted.Theexperimentalprotocolsdonotfullyassesssystemictoxicity,carcinogenicity,teratogenicity,ormutagenicityofthematerial.Otherstandardsareavailabletoaddresstheseissues.1.4Tomaximizeuseoftheanimalsinthestudyprotocol,alltoxicologicalfindingsshouldberecorded.Therearesomeaspectsofsystemictoxicity,includingeffectsofdegradationproductsonthetargetorgans,thatcanbeaddressedwiththispractice,andtheseeffectsshouldbedocumentedfully.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:
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