ASTM F2042-2000(2005) 医疗设施中用的硅弹性体、凝胶和泡沫的标准指南.第II部分:交联材料和制造
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【英文标准名称】:StandardGuideforSiliconeElastomers,Gels,andFoamsUsedinMedicalApplicationsPartII-CrosslinkingandFabrication
【原文标准名称】:医疗设施中用的硅弹性体、凝胶和泡沫的标准指南.第II部分:交联材料和制造
【标准号】:ASTMF2042-2000(2005)
【标准状态】:现行
【国别】:
【发布日期】:2000
【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】:F04.11
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:foam;gel;highconsistencyrubber;liquidsiliconerubber;medicaldevicematerial;moisturecure;peroxidecure;platinumcure;RTV
【摘要】:Thisguideisintendedtoprovideguidanceforthespecificationandselectionoffabricationmethodsforsiliconesusedinmedicaldevices.Italsoprovidesguidancerelativetotestingthatmightbedonetoqualifylotsofacceptablematerial,basedondesiredperformanceproperties.Siliconemanufacturerssupplyingmaterialtothemedicaldeviceindustryshouldreadilyprovideinformationregardingnon-proprietaryproductformulationtotheircustomerseitherdirectlyorthroughtheUSFDAMasterFileprogram.1.1Thisguideisintendedtoeducatepotentialusersofsiliconeelastomers,gelsandfoamsrelativetotheirfabricationandprocessing.Itdoesnotprovideinformationrelativetosiliconepowders,fluids,pressuresensitiveadhesives,orothertypesofsiliconeproducts.1.2Theinformationprovidedisofferedtoguideusersintheselectionofappropriateprocessingconditionsforspecificmedicaldeviceapplications.1.3Formulationandselectionofappropriatestartingmaterialsiscoveredinthecompaniondocument,F2038PartI.Thismonographaddressesonlythecuring,post-curing,andprocessingofelastomers,gelsandfoamsaswellashowtheresultingproductisevaluated.1.4Siliconebiocompatibilityissuescanbeaddressedatseverallevels,butultimatelythedevicemanufacturermustassessbiologicalsuitabilityrelativetointendeduse.Biocompatibilitytestingmaybedoneoncuredelastomerspriortofinalfabrication,butthemostrelevantdataarethoseobtainedonthefinisheddevice.Dataonselectedlotsofmaterialareonlyrepresentativewhencompounding,andfabricationareperformedunderacceptedqualitysystemssuchasISO9001andcurrentGoodManufacturingPracticeRegulations.Extractablesanalysesmayalsobeofinterestforinvestigationofbiocompatibility,andtheproceduresforobtainingsuchdatadependonthegoalofthestudy(seeF619,theHIMAMemorandum7/14/93,andUSP23,forexamplesofextractionmethods).
【中国标准分类号】:C30
【国际标准分类号】:11_040_40
【页数】:7P.;A4
【正文语种】:
【原文标准名称】:医疗设施中用的硅弹性体、凝胶和泡沫的标准指南.第II部分:交联材料和制造
【标准号】:ASTMF2042-2000(2005)
【标准状态】:现行
【国别】:
【发布日期】:2000
【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】:F04.11
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:foam;gel;highconsistencyrubber;liquidsiliconerubber;medicaldevicematerial;moisturecure;peroxidecure;platinumcure;RTV
【摘要】:Thisguideisintendedtoprovideguidanceforthespecificationandselectionoffabricationmethodsforsiliconesusedinmedicaldevices.Italsoprovidesguidancerelativetotestingthatmightbedonetoqualifylotsofacceptablematerial,basedondesiredperformanceproperties.Siliconemanufacturerssupplyingmaterialtothemedicaldeviceindustryshouldreadilyprovideinformationregardingnon-proprietaryproductformulationtotheircustomerseitherdirectlyorthroughtheUSFDAMasterFileprogram.1.1Thisguideisintendedtoeducatepotentialusersofsiliconeelastomers,gelsandfoamsrelativetotheirfabricationandprocessing.Itdoesnotprovideinformationrelativetosiliconepowders,fluids,pressuresensitiveadhesives,orothertypesofsiliconeproducts.1.2Theinformationprovidedisofferedtoguideusersintheselectionofappropriateprocessingconditionsforspecificmedicaldeviceapplications.1.3Formulationandselectionofappropriatestartingmaterialsiscoveredinthecompaniondocument,F2038PartI.Thismonographaddressesonlythecuring,post-curing,andprocessingofelastomers,gelsandfoamsaswellashowtheresultingproductisevaluated.1.4Siliconebiocompatibilityissuescanbeaddressedatseverallevels,butultimatelythedevicemanufacturermustassessbiologicalsuitabilityrelativetointendeduse.Biocompatibilitytestingmaybedoneoncuredelastomerspriortofinalfabrication,butthemostrelevantdataarethoseobtainedonthefinisheddevice.Dataonselectedlotsofmaterialareonlyrepresentativewhencompounding,andfabricationareperformedunderacceptedqualitysystemssuchasISO9001andcurrentGoodManufacturingPracticeRegulations.Extractablesanalysesmayalsobeofinterestforinvestigationofbiocompatibility,andtheproceduresforobtainingsuchdatadependonthegoalofthestudy(seeF619,theHIMAMemorandum7/14/93,andUSP23,forexamplesofextractionmethods).
【中国标准分类号】:C30
【国际标准分类号】:11_040_40
【页数】:7P.;A4
【正文语种】:
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