DIN EN ISO 21534-2009 非活性外科植入物.关节替代植入物.特殊要求(ISO21534-2007);德文版本ENISO21534-2009
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【英文标准名称】:Non-activesurgicalimplants-Jointreplacementimplants-Particularrequirements(ISO21534:2007);EnglishversionofDINENISO21534:2009-08
【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(ISO21534-2007);德文版本ENISO21534-2009
【标准号】:DINENISO21534-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【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】:合金;应用;人工器官;生物危害;壳体;骨胶结剂;陶瓷;检验;临床的;结构细节;触点;制造日期;定义;设计;评定;精密机械;精整;功能可靠性;功能性;功能;铰链;植入物(外科);钝性的;信息;关节置换;连接件;关节;文字书写;作标记;材料;测量;测量技术;医疗器械;医疗设备;医学科学;金属;骨接合术;包装件;塑料;抛光;位置;生产;替换油;粗糙度(表面);规范(验收);灭菌;表面;外科学;外科植入物;试验;地形学
【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】:C45
【国际标准分类号】:11_040_40
【页数】:22P.;A4
【正文语种】:英语
【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(ISO21534-2007);德文版本ENISO21534-2009
【标准号】:DINENISO21534-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【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】:合金;应用;人工器官;生物危害;壳体;骨胶结剂;陶瓷;检验;临床的;结构细节;触点;制造日期;定义;设计;评定;精密机械;精整;功能可靠性;功能性;功能;铰链;植入物(外科);钝性的;信息;关节置换;连接件;关节;文字书写;作标记;材料;测量;测量技术;医疗器械;医疗设备;医学科学;金属;骨接合术;包装件;塑料;抛光;位置;生产;替换油;粗糙度(表面);规范(验收);灭菌;表面;外科学;外科植入物;试验;地形学
【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】:C45
【国际标准分类号】:11_040_40
【页数】:22P.;A4
【正文语种】:英语
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