【英文标准名称】:Non-activesurgicalimplants-Jointreplacementimplants-Particularrequirements
【原文标准名称】:非有源外科植入物.关节置换植入物.特殊要求
【标准号】:ISO21534-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-10
【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】:人工器官;骨粘接剂;陶瓷;检验;结构细节;制造日期;定义;设计;精密机械;精整;功能可靠性;功能性;功能;铰链;外科植入物;钝性的;信息;关节置换;连接件;关节;作标记;材料;医疗设备;医学科学;金属;骨接合术;包装件;塑料;生产;规范(验收);灭菌;外科学;测试
【英文主题词】:Alloys;Applications;Artificialorgans;Biologicalhazards;Bodies;Bonecements;Ceramics;Checks;Clinical;Constructiondetails;Contact;Dataofthemanufacturer;Definitions;Design;Evaluations;Finemechanics;Finishes;Functionalreliability;Functionality;Functions;Hinges;Implants(surgical);Inactive;Information;Jointreplacement;Joints;Joints(anatomy);Letterings;Marking;Materials;Measurement;Measuringtechniques;Medicaldevices;Medicalequipment;Medicalsciences;Metals;Osteosyntheses;Packages;Plastics;Polishing;Position;Production;Replacement;Roughness(surface);Specification(approval);Sterilization(hygiene);Surfaces;Surgery;Surgicalimplants;Testing;Topography
【摘要】:ThisInternationalStandardspecifiesparticularrequirementsfortotalandpartialjointreplacementimplants,artificialligamentsandbonecement,hereafterreferredtoasimplants.ForthepurposesofthisInternationalStandard,artificialligamentsandtheirassociatedfixingdevicesareincludedintheterm"implant".Itspecifiesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilization,packagingandinformationtobesuppliedbythemanufacturer.SometestsrequiredtodemonstrateconformancetothisInternationalStandardarecontainedinorreferencedinlevel3standards.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:13P;A4
【正文语种】:英语