ISO 16061-2000 与非有源外科植入物相关的仪器.一般要求

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【英文标准名称】:Instrumentationforuseinassociationwithnon-activesurgicalimplants-Generalrequirements
【原文标准名称】:与非有源外科植入物相关的仪器.一般要求
【标准号】:ISO16061-2000
【标准状态】:作废
【国别】:国际
【发布日期】:2000-03
【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】:一般条件;生产;检验;设计;包装件;钝性的;组分;外科学;材料;外科植入物;外科植入物;手术器械;作标记;试验;规范(验收);灭菌;外科设备;医疗设备;医学科学;定义
【英文主题词】:Checks;Composition;Definition;Definitions;Design;Generalconditions;Implants(surgical);Inactive;Marking;Materials;Medicalequipment;Medicalsciences;Packages;Production;Specification(approval);Sterilization(hygiene);Surgery;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing
【摘要】:ThisInternationalStandardspecifiesgeneralrequirementsforinstrumentstobeusedinassociationwithnon-activesurgicalimplants.Theserequirementsapplytoinstrumentswhentheyaremanufacturedandwhentheyareresuppliedafterrefurbishment.ThisInternationalStandardappliestoinstrumentswhichmaybeconnectedtopower-drivensystems,butdoesnotapplytothepower-drivensystemsthemselves.Withregardtosafety,thisInternationalStandardgivesrequirementsforintendedperformance,designattributes,selectionofmaterials,designevaluation,manufacture,sterilization,packagingandinformationtobesuppliedbythemanufacturer.ThisInternationalStandardisnotapplicabletoinstrumentsassociatedwithdentalimplants,transendodonticandtransradicularimplantsandophthalmicimplants.NOTEReferencestostandardsfornon-activesurgicalimplantsarelistedintheBibliography.
【中国标准分类号】:C35
【国际标准分类号】:11_040_30
【页数】:19P;A4
【正文语种】:英语