BS EN ISO 14630-2009 非有源外科植入物.一般要求

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                   【英文标准名称】:     Non-active surgical implants - General requirements            【原文标准名称】:     非有源外科植入物.一般要求            【标准号】:     BS EN ISO 14630-2009            【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;Biological hazards;Checks;Clinical;Construction details;Damage;Data of the manufacturer;Definitions;Design;English language;Evaluations;Fine mechanics;General section;Implants (surgical);Inactive;Information;Labelling;Marking;Materials;Medical devices;Medical equipment;Medical instruments;Medical products;Medical sciencesackageserformanceroductionrotection;Residues;Specification (approval);Sterile;Sterility;Sterilization (hygiene);Surgery;Surgical;Surgical implants;Testing;Transport【摘要】: This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials,transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.With regard to safety, this International Standard gives requirements for intended performance, designattributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.NOTE This International Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure the implant achieves its intended performance.【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