DIN EN 12006-3-2009 非活性外科植入物.心脏和血管植入物的详细要求.第3部分:血管内装置(包括修改件A1-2009).英文版本DINEN12006-3-2009-08
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【英文标准名称】:Nonactivesurgicalimplants-Particularrequirementsforcardiacandvascularimplants-Part3:Endovasculardevices(includesAmendmentA1:2009);EnglishversionofDINEN12006-3:2009-08
【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.第3部分:血管内装置(包括修改件A1-2009).英文版本DINEN12006-3-2009-08
【标准号】:DINEN12006-3-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【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;血管的;心脏;植入物(外科);检验;作标记;机械性能;医疗产品;医疗技术学;规范(验收);外科植入物;试验;血管假体;血管支架;腔静脉滤器
【英文主题词】:Bloodfiltrationinstruments;Cardiacvalves;Definitions;Dimensions;Endovascular;Heart;Implants(surgical);Inspection;Marking;Mechanicalproperties;Medicalproducts;Medicaltechnology;Specification(approval);Surgicalimplants;Testing;Vascularprostheses;Vascularstents;Venacavafilters
【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】:C45
【国际标准分类号】:11_040_40
【页数】:16P.;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.第3部分:血管内装置(包括修改件A1-2009).英文版本DINEN12006-3-2009-08
【标准号】:DINEN12006-3-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【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;血管的;心脏;植入物(外科);检验;作标记;机械性能;医疗产品;医疗技术学;规范(验收);外科植入物;试验;血管假体;血管支架;腔静脉滤器
【英文主题词】:Bloodfiltrationinstruments;Cardiacvalves;Definitions;Dimensions;Endovascular;Heart;Implants(surgical);Inspection;Marking;Mechanicalproperties;Medicalproducts;Medicaltechnology;Specification(approval);Surgicalimplants;Testing;Vascularprostheses;Vascularstents;Venacavafilters
【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】:C45
【国际标准分类号】:11_040_40
【页数】:16P.;A4
【正文语种】:英语
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