DIN EN ISO 21534-2007 非活性外科植入物.关节替代植入物.特殊要求

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【英文标准名称】:Non-activesurgicalimplants-Jointreplacementimplants-Particularrequirements(ISO21534:2007);GermanversionENISO21534:2007
【原文标准名称】:非活性外科植入物.关节替代植入物.特殊要求
【标准号】:DINENISO21534-2007
【标准状态】:作废
【国别】:德国
【发布日期】:2007-12
【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】: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;关节替代;连接件;关节(解剖学);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】:20P;A4
【正文语种】:德语