ISO 5840-2005 心血管植入物.心脏瓣膜假体
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【英文标准名称】:Cardiovascularimplants-Cardiacvalveprostheses
【原文标准名称】:心血管植入物.心脏瓣膜假体
【标准号】:ISO5840-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【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;评估;精密机械;心脏;外科植入物;在体外;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;性能;修复装置;质量保证;危险;规范(验收);灭菌;测试;用户信息;血管假体;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;Medicaldevices;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】:84P;A4
【正文语种】:英语
【原文标准名称】:心血管植入物.心脏瓣膜假体
【标准号】:ISO5840-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【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;评估;精密机械;心脏;外科植入物;在体外;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;性能;修复装置;质量保证;危险;规范(验收);灭菌;测试;用户信息;血管假体;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;Medicaldevices;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】:84P;A4
【正文语种】:英语
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