标准摘要
[中文适用范围]： 本文件规定了确保和证明为用于医疗设备的材料进行动物试验以评估其生物相容性所必需的最低要求。 本文件适用于那些委托、设计和执行用于评估医疗设备材料（或设备本身）生物相容性的试验，或分析由此获得的数据的人。 本文件提出建议和指导，旨在促进未来进一步减少动物数量，改进测试方法以减少或消除对动物的痛苦或压力，并通过其他科学上有效的手段替代动物试验。 本文件适用于在活体非人脊椎动物上进行的用于建立材料或医疗设备生物相容性的试验。 [外文原描述]： This document 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 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. This document 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. This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. This document 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.
英文名称Biological evaluation of medical devices — Part 2: Animal welfare requirements