BS EN 12006-3-1998+A1-2009 非活性外科植入物.心脏和血管植入物的详细要求.血管内植入物
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【英文标准名称】:Nonactivesurgicalimplants-Particularrequirementsforcardiacandvascularimplants-Endovasculardevices
【原文标准名称】:非活性外科植入物.心脏和血管植入物的详细要求.血管内植入物
【标准号】:BSEN12006-3-1998+A1-2009
【标准状态】:作废
【国别】:英国
【发布日期】:1999-03-15
【实施或试行日期】:1999-03-15
【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】:血液过滤器;心脏瓣膜;定义;尺寸;心脏;外科植入物;检验;作标记;材料;测量;机械性能;医疗技术学;包装件;质量保证;规范(验收);血管假体;血管支架;腔静脉滤器;验证
【英文主题词】:Bloodfiltrationinstruments;Cardiacvalves;Definitions;Dimensions;Heart;Implants(surgical);Inspection;Marking;Materials;Measurement;Mechanicalproperties;Medicaltechnology;Packages;Qualityassurance;Specification(approval);Surgicalimplants;Vascularprostheses;Vascularstents;Venacavafilters;Verification
【摘要】:ThisEuropeanStandardspecifiesparticularrequirementsforendovasculardevices.Withregardtosafety,thisstandardgivesinadditiontoENISO14630,requirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilization,packagingandinformationsuppliedbythemanufacturer.NOTE1Vascularoccludersarenotaddressedinthisstandard.ForthetimebeingtherequirementsasstatedinENISO14630:1997applyfortheseproducts.NOTE2Duetothevariationsinthedesignoftheimplantscoveredbythisstandardandinsomecasesduetotherelativelyrecentdevelopmentofsomeoftheseimplants,acceptablestandardizedinvitrotestsandlongtermresultsofclinicaltrialsarenotalwaysavailable.Wherenotestmethodisdescribedinthisstandardacompletedescriptionofthevalidatedtestmethodandsamplepreparationprocedureusedshouldbedocumentedbythemanufacturer.Withregardtodesignevaluation,whereaspecificstandardizedtestisnotdescribed,guidanceisgivenbyreferringtocurrentscientificliterature(seeAnnexA).Thisstandardaimstoensurethatmanufacturerswilladdressallaspectsofdesignevaluationthatrelatetothesafetyoftheproduct.Asfurtherscientificandclinicaldatabecomeavailable,appropriaterevisionofthestandardwillbenecessary.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:18P.;A4
【正文语种】:英语
【原文标准名称】:非活性外科植入物.心脏和血管植入物的详细要求.血管内植入物
【标准号】:BSEN12006-3-1998+A1-2009
【标准状态】:作废
【国别】:英国
【发布日期】:1999-03-15
【实施或试行日期】:1999-03-15
【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】:血液过滤器;心脏瓣膜;定义;尺寸;心脏;外科植入物;检验;作标记;材料;测量;机械性能;医疗技术学;包装件;质量保证;规范(验收);血管假体;血管支架;腔静脉滤器;验证
【英文主题词】:Bloodfiltrationinstruments;Cardiacvalves;Definitions;Dimensions;Heart;Implants(surgical);Inspection;Marking;Materials;Measurement;Mechanicalproperties;Medicaltechnology;Packages;Qualityassurance;Specification(approval);Surgicalimplants;Vascularprostheses;Vascularstents;Venacavafilters;Verification
【摘要】:ThisEuropeanStandardspecifiesparticularrequirementsforendovasculardevices.Withregardtosafety,thisstandardgivesinadditiontoENISO14630,requirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilization,packagingandinformationsuppliedbythemanufacturer.NOTE1Vascularoccludersarenotaddressedinthisstandard.ForthetimebeingtherequirementsasstatedinENISO14630:1997applyfortheseproducts.NOTE2Duetothevariationsinthedesignoftheimplantscoveredbythisstandardandinsomecasesduetotherelativelyrecentdevelopmentofsomeoftheseimplants,acceptablestandardizedinvitrotestsandlongtermresultsofclinicaltrialsarenotalwaysavailable.Wherenotestmethodisdescribedinthisstandardacompletedescriptionofthevalidatedtestmethodandsamplepreparationprocedureusedshouldbedocumentedbythemanufacturer.Withregardtodesignevaluation,whereaspecificstandardizedtestisnotdescribed,guidanceisgivenbyreferringtocurrentscientificliterature(seeAnnexA).Thisstandardaimstoensurethatmanufacturerswilladdressallaspectsofdesignevaluationthatrelatetothesafetyoftheproduct.Asfurtherscientificandclinicaldatabecomeavailable,appropriaterevisionofthestandardwillbenecessary.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:18P.;A4
【正文语种】:英语
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