ANSI/AAMI/ISO 10993-2-2006 医疗器械的生物评定.第2部分:动物福利要求
【英文标准名称】: Biological evaluation of medical devices - Part 2: Animal welfare requirements 【原文标准名称】: 医疗器械的生物评定.第2部分:动物福利要求 【标准号】: ANSI/AAMI/ISO 10993-2-2006 【标准状态】: 现行 【国别】: 美国 【发布日期】: 2006-07-26 【实施或试行日期】: 【发布单位】: 美国国家标准学会(US-ANSI)【起草单位】: AAMI【标准类型】: ()【标准水平】: ()【中文主题词】: 设计; ;医疗设备;规范(验收)【英文主题词】: Design;Experimental animals;Medical equipment;Specification (approval)【摘要】: This part of ISO 10993 is aimed at those who commision, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or of the meducal devices themselves. It specifies the miniumum requirements to be satisfied to ensure and demonstrate that proper provission has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.【中国标准分类号】: C30【国际标准分类号】: 11_020【页数】: 【正文语种】: 英语
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