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【英文标准名称】:Non-activesurgicalimplants-Generalrequirements
【原文标准名称】:非有源外科植入物.一般要求
【标准号】:ISO14630-2008
【标准状态】:作废
【国别】:国际
【发布日期】:2008-01
【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】:检验;结构细节;制造日期;定义;设计;精密机械;总论;外科植入物;钝性的;加标签;作标记;材料;医疗设备;医疗器械;医疗产品;医学科学;包装件;性能;生产;规范(验收);灭菌;外科学;测试
【英文主题词】:Bearings;Biologicalhazards;Checks;Clinical;Constructiondetails;Damage;Dataofthemanufacturer;Definitions;Design;Englishlanguage;Evaluations;Finemechanics;Generalsection;Implants(surgical);Inactive;Information;Labelling;Marking;Materials;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Packages;Performance;Production;Protection;Residues;Specification(approval);Sterile;Sterility;Sterilization(hygiene);Surgery;Surgical;Surgicalimplants;Testing;Transport
【摘要】:ThisInternationalStandardspecifiesgeneralrequirementsfornon-activesurgicalimplants,hereafterreferredtoasimplants.ThisInternationalStandardisnotapplicabletodentalimplants,dentalrestorativematerialstransendodonticandtransradicularimplants,intra-ocularlensesandimplantsutilizingviableanimaltissue.Withregardtosafety,thisInternationalStandardgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacture,sterilization,packagingandinformationsuppliedbythemanufacturer,andteststodemonstratecompliancewiththeserequirements.AdditionaltestsaregivenQ(referredtoinlevel2andlevel3standards.NOTEThisInternationalStandarddoesnotrequirethatthemanufacturerhaveaqualitymanagementsysteminplace.However,theapplicationofaqualitymanagementsystem,suchasthatdescribedinISO13485couldbeappropriatetohelpensuretheimplantachievesitsintendedperformance.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:14P;A4
【正文语种】:英语