ISO 14630-2005 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】:     ISO 14630-2005            【标准状态】:     作废            【国别】:     国际            【发布日期】:     2005-05    【实施或试行日期】: 【发布单位】: 国际标准化组织(ISO)【起草单位】: ISO/TC 150【标准类型】: ()【标准水平】: ()【中文主题词】: 生产;作标记;医学科学;设计;制造日期;定义;试验;规范(验收);材料;精密机械;灭菌;检验;包装件;外科植入物;外科植入物;医疗器械;性能;外科学;医疗产品;医疗设备;钝性的【英文主题词】: 【摘要】: This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 standards.【中国标准分类号】: C35【国际标准分类号】: 11_040_40【页数】: 13P;A4【正文语种】: 英语