【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
【标准号】:ANSI/AAMI/ISO5840-2005
【标准状态】:现行
【国别】:美国
【发布日期】:2004-12-13
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:AAMI
【标准类型】:()
【标准水平】:()
【中文主题词】:外科植入物;医疗设备;修复装置
【英文主题词】:Cardiacvalves;Chemicalproperties;Definition;Definitions;Design;Dimensions;Durability;Endurancetests;Evaluations;Heart;Implants(surgical);Inspection;Marking;Materials;Measurement;Medicalequipment;Medicalsciences;Medicaltechnology;Packages;Physicalproperties;Properties;Prostheticdevices;Qualityassurance;Specification(approval);Sterilization(hygiene);Surgicalimplants;Testing;Userinformation;Vascularprostheses;Verification
【摘要】:Outlinesanapproachforqualifyingthedesignandmanufactureofaheartvalvesubstitutethroughriskmanagement.Theselectionofappropriatequalificationtestsandmethodsaretobederivedfromtheriskassessment.Imposesdesignspecificationsandminimumperformancespecificationsforheartvalvesubstituteswhereadequatescientificand/orclinicalevidenceexistsfortheirjustification.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:87P.;A4
【正文语种】:英语