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【英文标准名称】:Non-activesurgicalimplants-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特殊要求.血管内植入物
【标准号】:BSEN12006-3-1999
【标准状态】:现行
【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(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:循环系统;设计计算;血管;灭菌;疲劳;设计;心脏病学;耐腐蚀性;腐蚀试验;修复术;力的测量;性能试验;医学专业;外科植入物;材料强度;文献索引;表面缺陷;疲劳试验;性能;尺寸;使用说明;外科设备;医疗设备
【英文主题词】:
【摘要】:ThisEuropeanStandardspecifiesparticularrequirementsforendovasculardevices.Withregardtosafety,thisstandardgives,inadditiontoENISO14630,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】:10P;A4
【正文语种】:英语