ISO 10993-2-2006 医疗器械的生物学评价.第2部分:动物保护要求
【英文标准名称】: Biological evaluation of medical devices - Part 2: Animal welfare requirements 【原文标准名称】: 医疗器械的生物学评价.第2部分:动物保护要求 【标准号】: ISO 10993-2-2006 【标准状态】: 现行 【国别】: 国际 【发布日期】: 2006-07 【实施或试行日期】: 【发布单位】: 国际标准化组织(IX-ISO)【起草单位】: ISO/TC 194【标准类型】: ()【标准水平】: ()【中文主题词】: 畜牧业;动物保护;生物测定;生物试验;兼容性试验;定义;文献工作;实验动物;精密机械;人用的药物;实验室动物;医疗设备;医疗产品;医学科学;人员;药剂学;产品试验;研究;规范(验收);外科设备;外科植入物;试验;证实【英文主题词】: Animal husbandry;Animal protection;Bioassay;Biological tests;Compatibility tests;Definitions;Documentations;Experimental animals;Fine mechanics;Human medicine;Implants (surgical);Laboratory animals;Medical devices;Medical equipment;Medical products;Medical sciences;Personnel;Pharmacy;Product tests;Research;Specification (approval);Surgical equipment;Surgical implants;Validation【摘要】: This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.【中国标准分类号】: C30【国际标准分类号】: 11_100_20【页数】: 13P;A4【正文语种】: 英语
这个可以下载么？:):):):)
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