【英文标准名称】:Cardiovascularimplants-Cardiacvalveprostheses
【原文标准名称】:心血管植入物.心脏瓣膜修复术
【标准号】:BSENISO5840-2005
【标准状态】:作废
【国别】:英国
【发布日期】:2006-12-29
【实施或试行日期】:2006-12-29
【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】:心脏瓣膜;化学性质;定义;设计;尺寸;耐久性;耐用试验;评定;精密机械;心脏;植入物(外科);在实验室条件下;在体内;检验;作标记;材料试验;材料;测量;医疗技术学;包装件;物理性能;特性;修复装置;质量保证;危险;规范(验收);灭菌;外科植入物;试验;用户信息;动脉修复;验证
【英文主题词】:Cardiacvalves;Chemicalproperties;Definitions;Design;Dimensions;Durability;Endurancetests;Englishlanguage;Evaluations;Finemechanics;Heart;Implants(surgical);Invitro;Invivo;Inspection;Marking;Materialtests;Materials;Measurement;Medicaltechnology;Packages;Physicalproperties;Properties;Prostheticdevices;Qualityassurance;Risk;Specification(approval);Sterilization(hygiene);Surgicalimplants;Testing;Userinformation;Vascularprostheses;Verification
【摘要】:ThisInternationalStandardisapplicabletoalldevicesintendedforimplantationinhumanhearts,asaheartvalvesubstitute.ThisInternationalStandardisapplicabletobothnewlydevelopedandmodifiedheartvalvesubstitutesandtotheaccessorydevices,packagingandlabellingrequiredfortheirimplantationandfordeterminingtheappropriatesizeofheartvalvesubstitutetobeimplanted.ThisInternationalStandardoutlinesanapproachforqualifyingthedesignandmanufactureofaheartvalvesubstitutethroughriskmanagement.Theselectionofappropriatequalificationtestsandmethodsarederivedfromtheriskassessment.Thetestsmayincludethosetoassessthephysical,chemical,biologicalandmechanicalpropertiesofheartvalvesubstitutesandoftheirmaterialsandcomponents.Thetestsmayalsoincludethoseforpre-clinicalinvivoevaluationandclinicalevaluationofthefinishedheartvalvesubstitute.ThisInternationalStandardimposesdesignspecificationsandminimumperformancespecificationsforheartvalvesubstituteswhereadequatescientificand/orclinicalevidenceexistsfortheirjustification.ThisInternationalStandardexcludesheartvalvesubstitutesdesignedforimplantationinartificialheartsorheartassistdevices.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:96P.;A4
【正文语种】:英语