DIN EN ISO 5840-2006 心血管植入物.心脏瓣膜修复术(ISO5840-2005).德文版本ENISO5840:2005
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【英文标准名称】:Cardiovascularimplants-Cardiacvalveprostheses(ISO5840:2005);GermanversionENISO5840:2005
【原文标准名称】:心血管植入物.心脏瓣膜修复术(ISO5840-2005).德文版本ENISO5840:2005
【标准号】:DINENISO5840-2006
【标准状态】:作废
【国别】:德国
【发布日期】:2006-03
【实施或试行日期】:
【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】: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;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;血管修复术;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】:ThisInternationalStandardimposesdesignspecificationsandminimumperformancespecificationsforheartvalvesubstitutes.Itisapplicabletobothnewlydevelopedandmodifiedheartvalvesubstitutesandtotheaccessorydevices,packagingandlabellingrequiredfortheirimplantationandfordeterminingtheappropriatesizeoftheheartvalvesubstitutetobeimplanted.Anapproachforqualifyingthedesignandmanufactureofaheartvalvesubstitutethroughriskmanagementisgiven.Theselectionofappropriatequalificationtestsandmethodsaretobederivedfromtheriskassessment.Thetestsmayincludethosetoassessthephysical,chemical,biological,andmechanicalpropertiesofheartvalvesubstitutesandoftheirmaterialsandcomponents.Thestandardexcludesheartvalvesubstitutesdesignedforimplantationinartificialheartsorheartassistdevices.
【中国标准分类号】:C45
【国际标准分类号】:01_040_11;11_040_40
【页数】:99P;A4
【正文语种】:德语
【原文标准名称】:心血管植入物.心脏瓣膜修复术(ISO5840-2005).德文版本ENISO5840:2005
【标准号】:DINENISO5840-2006
【标准状态】:作废
【国别】:德国
【发布日期】:2006-03
【实施或试行日期】:
【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】: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;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;血管修复术;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】:ThisInternationalStandardimposesdesignspecificationsandminimumperformancespecificationsforheartvalvesubstitutes.Itisapplicabletobothnewlydevelopedandmodifiedheartvalvesubstitutesandtotheaccessorydevices,packagingandlabellingrequiredfortheirimplantationandfordeterminingtheappropriatesizeoftheheartvalvesubstitutetobeimplanted.Anapproachforqualifyingthedesignandmanufactureofaheartvalvesubstitutethroughriskmanagementisgiven.Theselectionofappropriatequalificationtestsandmethodsaretobederivedfromtheriskassessment.Thetestsmayincludethosetoassessthephysical,chemical,biological,andmechanicalpropertiesofheartvalvesubstitutesandoftheirmaterialsandcomponents.Thestandardexcludesheartvalvesubstitutesdesignedforimplantationinartificialheartsorheartassistdevices.
【中国标准分类号】:C45
【国际标准分类号】:01_040_11;11_040_40
【页数】:99P;A4
【正文语种】:德语
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