ASTM F619-2003 医学塑料制品萃取的标准实施规范
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【英文标准名称】:StandardPracticeforExtractionofMedicalPlastics
【原文标准名称】:医学塑料制品萃取的标准实施规范
【标准号】:ASTMF619-2003
【标准状态】:现行
【国别】:
【发布日期】:2003
【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】:医学科学;萃取;医疗设备;塑料;工艺
【英文主题词】:biocompatibility;extraction;liquids;plastics;specimensize;
【摘要】:Theseextractionproceduresaretheinitialpartofseveraltestproceduresusedinthebiocompatibilityscreeningofplasticsusedinmedicaldevices.Thelimitationsoftheresultsobtainedfromthispracticeshouldberecognized.Thechoiceofextractionvehicle,durationofimmersion,andtemperatureofthetestisnecessarilyarbitrary.Thespecificationoftheseconditionsprovidesabasisforstandardizationandservesasaguidetoinvestigatorswishingtocomparetherelativeresistanceofvariousplasticstoextractionvehicles.Correlationoftestresultswiththeactualperformanceorserviceabilityofmaterialsisnecessarilydependentuponthesimilaritybetweenthetestingandend-useconditions(see12.1.2andNote4).Cautionshouldbeexercisedintheunderstandingandintentofthispracticeasfollows:5.4.1Noallowanceordistinctionismadeforvariablessuchasend-useapplicationanddurationofuse.DecisionsonselectionofteststobedoneshouldbemadebasedonPracticeF748.5.4.2Thispracticewasoriginallydesignedforusewithnonporous,solidmaterials.Itsapplicationforothermaterials,suchasthosethatareporous,orabsorptive,orresorptive,shouldbeconsideredwithcaution.Considerationshouldbegiventoalteringthespecifiedmaterialtoliquidratiotoallowadditionalliquidtofullyhydratethematerialandadditionalliquidorothermethodstofullysubmergethetestarticle.Additionalproceduresthatfullyremovetheextractliquidfromthetestarticle,suchaspressureorphysicallysqueezingthematerial,shouldalsobeconsideredasappropriate.Althoughnodefinitionsaregiveninthispracticeforthefollowingterms,suchitemsasextractionvehiclesurfacetensionatthespecifiedextractionconditionandplasticspecimenphysicalstructureshouldbetakenintoaccount.TestMethodsD543,D570,andD1239maybeusefulinprovidingsupplementalinformation.1.1Thispracticecoversmethodsofextractionofmedicalplasticsandmaybeapplicabletoothermaterials.Thispracticeidentifiesamethodforobtaining"extractliquid"foruseindeterminingthebiologicalresponseinpreclinicaltesting.Furthertestingofthe"extractliquid"isspecifiedinotherASTMstandards.Theextractmayundergochemicalanalysisaspartofthepreclinicalevaluationofthebiologicalresponse,andthematerialafterextractionmayalsobeexamined.1.2Thispracticemaybeusedfor,butisnotlimitedtothefollowingareas:partialevaluationofrawmaterials,auditingmaterialswithinthemanufacturingprocess,andtestingfinalproducts.Thispracticemayalsobeusedasarefereemethodforthemeasurementofextractablesinplasticsusedinmedicaldevices.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G33
【国际标准分类号】:11_120_01;83_080_01
【页数】:4P.;A4
【正文语种】:
【原文标准名称】:医学塑料制品萃取的标准实施规范
【标准号】:ASTMF619-2003
【标准状态】:现行
【国别】:
【发布日期】:2003
【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】:医学科学;萃取;医疗设备;塑料;工艺
【英文主题词】:biocompatibility;extraction;liquids;plastics;specimensize;
【摘要】:Theseextractionproceduresaretheinitialpartofseveraltestproceduresusedinthebiocompatibilityscreeningofplasticsusedinmedicaldevices.Thelimitationsoftheresultsobtainedfromthispracticeshouldberecognized.Thechoiceofextractionvehicle,durationofimmersion,andtemperatureofthetestisnecessarilyarbitrary.Thespecificationoftheseconditionsprovidesabasisforstandardizationandservesasaguidetoinvestigatorswishingtocomparetherelativeresistanceofvariousplasticstoextractionvehicles.Correlationoftestresultswiththeactualperformanceorserviceabilityofmaterialsisnecessarilydependentuponthesimilaritybetweenthetestingandend-useconditions(see12.1.2andNote4).Cautionshouldbeexercisedintheunderstandingandintentofthispracticeasfollows:5.4.1Noallowanceordistinctionismadeforvariablessuchasend-useapplicationanddurationofuse.DecisionsonselectionofteststobedoneshouldbemadebasedonPracticeF748.5.4.2Thispracticewasoriginallydesignedforusewithnonporous,solidmaterials.Itsapplicationforothermaterials,suchasthosethatareporous,orabsorptive,orresorptive,shouldbeconsideredwithcaution.Considerationshouldbegiventoalteringthespecifiedmaterialtoliquidratiotoallowadditionalliquidtofullyhydratethematerialandadditionalliquidorothermethodstofullysubmergethetestarticle.Additionalproceduresthatfullyremovetheextractliquidfromthetestarticle,suchaspressureorphysicallysqueezingthematerial,shouldalsobeconsideredasappropriate.Althoughnodefinitionsaregiveninthispracticeforthefollowingterms,suchitemsasextractionvehiclesurfacetensionatthespecifiedextractionconditionandplasticspecimenphysicalstructureshouldbetakenintoaccount.TestMethodsD543,D570,andD1239maybeusefulinprovidingsupplementalinformation.1.1Thispracticecoversmethodsofextractionofmedicalplasticsandmaybeapplicabletoothermaterials.Thispracticeidentifiesamethodforobtaining"extractliquid"foruseindeterminingthebiologicalresponseinpreclinicaltesting.Furthertestingofthe"extractliquid"isspecifiedinotherASTMstandards.Theextractmayundergochemicalanalysisaspartofthepreclinicalevaluationofthebiologicalresponse,andthematerialafterextractionmayalsobeexamined.1.2Thispracticemaybeusedfor,butisnotlimitedtothefollowingareas:partialevaluationofrawmaterials,auditingmaterialswithinthemanufacturingprocess,andtestingfinalproducts.Thispracticemayalsobeusedasarefereemethodforthemeasurementofextractablesinplasticsusedinmedicaldevices.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G33
【国际标准分类号】:11_120_01;83_080_01
【页数】:4P.;A4
【正文语种】:
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