ASTM F1635-2004a 外科植入物用水解可降解聚合树脂和制造模件的实验室降解试验的标准试验方法
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【英文标准名称】:StandardTestMethodforinVitroDegradationTestingofHydrolyticallyDegradablePolymerResinsandFabricatedFormsforSurgicalImplants
【原文标准名称】:外科植入物用水解可降解聚合树脂和制造模件的实验室降解试验的标准试验方法
【标准号】:ASTMF1635-2004a
【标准状态】:现行
【国别】:
【发布日期】:2004
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:使用;降解;在实验室条件下;外科植入物;试验;生物降解能力;人造树脂;医疗技术学;高聚物
【英文主题词】:absorbable;bioabsorbable;degradation;invitro;hydrolyticallydegradablepolymer;hydrolysis;PLA,poly(l-lacticacid);poly(d-lactide);poly(d,l-lactide);PGA,poly(glycolide);poly(caprolactone);poly(p-dioxanone);surgica
【摘要】:1.1Thistestmethodcoversinvitrodegradationofhydrolyticallydegradablepolymers(HDP)intendedforuseinsurgicalimplants.1.2TherequirementsofthistestmethodapplytoHDPsinvariousforms:1.2.1Virginpolymerresins,or1.2.2Anyformfabricatedfromvirginpolymersuchasasemi-finishedcomponentofafinishedproduct,afinishedproduct,whichmayincludepackagedandsterilizedimplants,oraspeciallyfabricatedtestspecimen.1.3Thistestmethodhasnoprovisionsformechanicalloading,fluidflow,orotherdynamicchallenges.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:
【原文标准名称】:外科植入物用水解可降解聚合树脂和制造模件的实验室降解试验的标准试验方法
【标准号】:ASTMF1635-2004a
【标准状态】:现行
【国别】:
【发布日期】:2004
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:使用;降解;在实验室条件下;外科植入物;试验;生物降解能力;人造树脂;医疗技术学;高聚物
【英文主题词】:absorbable;bioabsorbable;degradation;invitro;hydrolyticallydegradablepolymer;hydrolysis;PLA,poly(l-lacticacid);poly(d-lactide);poly(d,l-lactide);PGA,poly(glycolide);poly(caprolactone);poly(p-dioxanone);surgica
【摘要】:1.1Thistestmethodcoversinvitrodegradationofhydrolyticallydegradablepolymers(HDP)intendedforuseinsurgicalimplants.1.2TherequirementsofthistestmethodapplytoHDPsinvariousforms:1.2.1Virginpolymerresins,or1.2.2Anyformfabricatedfromvirginpolymersuchasasemi-finishedcomponentofafinishedproduct,afinishedproduct,whichmayincludepackagedandsterilizedimplants,oraspeciallyfabricatedtestspecimen.1.3Thistestmethodhasnoprovisionsformechanicalloading,fluidflow,orotherdynamicchallenges.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:
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