BS EN ISO 14630-2009 非有源外科植入物.一般要求
作者:标准资料网 时间:2024-05-03 13:22:10 浏览:8455
来源:标准资料网
下载地址: 点击此处下载
【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】:BSENISO14630-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-11-30
【实施或试行日期】:2009-11-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:轴承;生物危害;检验;临床的;结构细节;损伤;制造日期;定义;设计;英语;评定;精密机械;总论;植入物(外科);钝性的;信息;加标签;标志;材料;医疗用具;医疗设备;医疗器械;医疗产品;医学科学;包装件;性能;生产;保护(装置);残留物;规范(验收);消毒;无菌;灭菌;外科学;外科的;外科植入物;测试;运输
【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,dentalrestorativematerials,transendodonticandtransradicularimplants,intra-ocularlensesandimplantsutilizingviableanimaltissue.Withregardtosafety,thisInternationalStandardgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacture,sterilization,packagingandinformationsuppliedbythemanufacturer,andteststodemonstratecompliancewiththeserequirements.Additionaltestsaregivenorreferredtoinlevel2andlevel3standards.NOTEThisInternationalStandarddoesnotrequirethatthemanufacturerhaveaqualitymanagementsysteminplace.However,theapplicationofaqualitymanagementsystem,suchasthatdescribedinISO13485,couldbeappropriatetohelpensuretheimplantachievesitsintendedperformance.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:26P.;A4
【正文语种】:英语
【原文标准名称】:非有源外科植入物.一般要求
【标准号】:BSENISO14630-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-11-30
【实施或试行日期】:2009-11-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:轴承;生物危害;检验;临床的;结构细节;损伤;制造日期;定义;设计;英语;评定;精密机械;总论;植入物(外科);钝性的;信息;加标签;标志;材料;医疗用具;医疗设备;医疗器械;医疗产品;医学科学;包装件;性能;生产;保护(装置);残留物;规范(验收);消毒;无菌;灭菌;外科学;外科的;外科植入物;测试;运输
【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,dentalrestorativematerials,transendodonticandtransradicularimplants,intra-ocularlensesandimplantsutilizingviableanimaltissue.Withregardtosafety,thisInternationalStandardgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacture,sterilization,packagingandinformationsuppliedbythemanufacturer,andteststodemonstratecompliancewiththeserequirements.Additionaltestsaregivenorreferredtoinlevel2andlevel3standards.NOTEThisInternationalStandarddoesnotrequirethatthemanufacturerhaveaqualitymanagementsysteminplace.However,theapplicationofaqualitymanagementsystem,suchasthatdescribedinISO13485,couldbeappropriatetohelpensuretheimplantachievesitsintendedperformance.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:26P.;A4
【正文语种】:英语
下载地址: 点击此处下载