Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
医疗器械的生物学评估 - 第2部分:动物福利要求(ISO 10993-2:2006)
发布日期:
2006-07-15
实施日期:
2006-07-15
ISO 10993-2:2006针对的是那些委托,设计和执行测试或评估动物试验数据,用于评估旨在4568用于医疗设备或医疗设备本身的材料的生物相容性。它规定了满足的最低要求,以确保并证明为动物试验中使用的动物的福利作出适当规定,以评估医疗器械中使用的材料的生物相容性。
ISO 10993-2:2006还提出了建议和提供指导意图,旨在促进未来进一步减少动物总数,改进测试方法以减少或消除动物的疼痛或痛苦,并通过其他科学有效的替代动物试验意味着不需要动物试验。
它适用于除了人类以外的活的脊椎动物进行的测试,以确定材料或医疗设备的生物相容性
ISO 10993-2:2006 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 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.
ISO 10993-2:2006 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.