ISO 7198-1998 心血管植入物.血管假体
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【英文标准名称】:Cardiovascularimplants-Tubularvascularprostheses
【原文标准名称】:心血管植入物.血管假体
【标准号】:ISO7198-1998
【标准状态】:现行
【国别】:国际
【发布日期】:1998-08
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:心脏病学;定义;使用说明书;作标记;医疗设备;包装件;修复装置;规范(验收);外科植入物;血管假体
【英文主题词】:Cardiology;Definition;Definitions;Instructionsforuse;Marking;Medicalequipment;Packages;Prostheticdevices;Specification(approval);Surgicalimplants;Vascularprostheses
【摘要】:1ThisInternationalStandardspecifiesrequirementsrelatingtotesting,packaging,labellingandterminologyforsteriletubularvascularprosthesesintendedtoreplace,bypassortoformshuntsbetweensegmentsofthevascularsysteminhumans.ThisInternationalStandardaddressesvascularprosthesesthataremadewhollyorpartlyof:materialsofbiologicalorigin;synthetictextilematerials;andsyntheticnontextilematerials.Inaddition,guidanceforcharacterizationofcompoundandcompositeprosthesesisprovided.Itspecifiesthedesignationofmaterialsofmanufactureandtheconstruction,andspecifiesthedesignationofsizesanddimensionsofvascularprostheses.Itreferstobiologicalrequirementsofthematerialsofconstructionandofthefinishedproduct,takingintoaccounttheappropriatepartofthehorizontalInternationalStandardISO10993.ThisInternationalStandardalsospecifiesthedesignationofmechanicalproperties.Itdescribesmethodsforthemeasurementandverificationofthedimensionsandmechanicalpropertiesdeclaredbythemanufacturer.Itreferstosterilizationofprosthesesandspecifiesrequirementsforlabellingandpackaging.Italsoprovidesdefinitionsoftermsincommonuse.2ThisInternationalStandarddoesnotspecifyalltheperformanceordimensionalcharacteristics,butitdoesincludemethodsforverifyingthatthenominalvaluesdisclosedbythemanufacturerarewithinthepermittedtolerances.Theserecommendationsdonotpurporttocompriseacompletetestprogram.3ForthepurposesofthisInternationalStandard,thedisclosureoftestmethods,resultsandotherinformationonrequestshallrelatesolelytorequestsfromaNationalRegulatoryAuthoritywithresponsibilityforsurgicalimplants.ThisInternationalStandarddoesnotapplytohumandonortissuedevicessuchascryopreservedvessels.Alsoexcludedareallpatches,pledgetsandstents.
【中国标准分类号】:C05
【国际标准分类号】:11_040_40
【页数】:48P.;A4
【正文语种】:英语
【原文标准名称】:心血管植入物.血管假体
【标准号】:ISO7198-1998
【标准状态】:现行
【国别】:国际
【发布日期】:1998-08
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:心脏病学;定义;使用说明书;作标记;医疗设备;包装件;修复装置;规范(验收);外科植入物;血管假体
【英文主题词】:Cardiology;Definition;Definitions;Instructionsforuse;Marking;Medicalequipment;Packages;Prostheticdevices;Specification(approval);Surgicalimplants;Vascularprostheses
【摘要】:1ThisInternationalStandardspecifiesrequirementsrelatingtotesting,packaging,labellingandterminologyforsteriletubularvascularprosthesesintendedtoreplace,bypassortoformshuntsbetweensegmentsofthevascularsysteminhumans.ThisInternationalStandardaddressesvascularprosthesesthataremadewhollyorpartlyof:materialsofbiologicalorigin;synthetictextilematerials;andsyntheticnontextilematerials.Inaddition,guidanceforcharacterizationofcompoundandcompositeprosthesesisprovided.Itspecifiesthedesignationofmaterialsofmanufactureandtheconstruction,andspecifiesthedesignationofsizesanddimensionsofvascularprostheses.Itreferstobiologicalrequirementsofthematerialsofconstructionandofthefinishedproduct,takingintoaccounttheappropriatepartofthehorizontalInternationalStandardISO10993.ThisInternationalStandardalsospecifiesthedesignationofmechanicalproperties.Itdescribesmethodsforthemeasurementandverificationofthedimensionsandmechanicalpropertiesdeclaredbythemanufacturer.Itreferstosterilizationofprosthesesandspecifiesrequirementsforlabellingandpackaging.Italsoprovidesdefinitionsoftermsincommonuse.2ThisInternationalStandarddoesnotspecifyalltheperformanceordimensionalcharacteristics,butitdoesincludemethodsforverifyingthatthenominalvaluesdisclosedbythemanufacturerarewithinthepermittedtolerances.Theserecommendationsdonotpurporttocompriseacompletetestprogram.3ForthepurposesofthisInternationalStandard,thedisclosureoftestmethods,resultsandotherinformationonrequestshallrelatesolelytorequestsfromaNationalRegulatoryAuthoritywithresponsibilityforsurgicalimplants.ThisInternationalStandarddoesnotapplytohumandonortissuedevicessuchascryopreservedvessels.Alsoexcludedareallpatches,pledgetsandstents.
【中国标准分类号】:C05
【国际标准分类号】:11_040_40
【页数】:48P.;A4
【正文语种】:英语
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