BS EN ISO 14607-2009 非有源外科植入物.乳房植入物.特殊要求

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                   【英文标准名称】:     Non-active surgical implants - Mammary implants - Particular requirements            【原文标准名称】:     非有源外科植入物.乳房植入物.特殊要求            【标准号】:     BS EN ISO 14607-2009            【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】: 磨蚀;附属瓣叶;生物危害;长度变化;检验;胸腔;临床的;内聚;碰撞;结构细节;制造日期;定义;设计;扩散;英语;评定;延伸性;织物;植入物(外科);钝性的;信息;加标签;标志;材料;机械测试;力学;医疗用具;医疗设备;医疗器械;医疗产品;医学科学;包装件;生产;安全;安全要求;缝隙;硅;规范(验收);状况;灭菌;表面;外科学;外科植入物;抗扯裂强度;测试;阀门;体积【英文主题词】: Abrasion;Accompanying leaflets;Biological hazards;Change of length;Checks;Chest (anatomy);Clinical;Cohesion;Collisions;Construction details;Data of the manufacturer;Definitions;Design;Diffusion;English language;Evaluations;Extensibility;Fabrics;Implants (surgical);Inactive;Information;Labelling;Marking;Materials;Mechanical testing;Mechanics;Medical devices;Medical equipment;Medical instruments;Medical products;Medical sciencesackagesroduction;Safety;Safety requirements;Seams;Silicone;Specification (approval);Status;Sterilization (hygiene);Surfaces;Surgery;Surgical implants;Tear strength;Testing;Valves;Volume【摘要】: This International Standard specifies particular requirements for mammary implants for clinical practice.With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.【中国标准分类号】: C45【国际标准分类号】: 11_040_40【页数】: 39P.;A4【正文语种】: 英语         
         

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