BS ISO 7198-1998 心血管植入物.血管修复术
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【英文标准名称】:Cardiovascularimplants-Tubularvascularprostheses
【原文标准名称】:心血管植入物.血管修复术
【标准号】:BSISO7198-1998
【标准状态】:现行
【国别】:英国
【发布日期】:1998-10-15
【实施或试行日期】:1998-10-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:加标签;医疗设备;使用说明;尺寸;术语;数据采集;内压力;长度;名称与符号;管子(医疗);压力;质量控制;心脏病学;修复装置;数据分析;检验;循环系统;包装;试验条件;作标记;试样;外科植入物;临床试验
【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】:C45
【国际标准分类号】:11_040_40
【页数】:56P.;A4
【正文语种】:英语
【原文标准名称】:心血管植入物.血管修复术
【标准号】:BSISO7198-1998
【标准状态】:现行
【国别】:英国
【发布日期】:1998-10-15
【实施或试行日期】:1998-10-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:加标签;医疗设备;使用说明;尺寸;术语;数据采集;内压力;长度;名称与符号;管子(医疗);压力;质量控制;心脏病学;修复装置;数据分析;检验;循环系统;包装;试验条件;作标记;试样;外科植入物;临床试验
【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】:C45
【国际标准分类号】:11_040_40
【页数】:56P.;A4
【正文语种】:英语
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