本文件规定了为确保和证明已为动物试验中使用的动物的福利制定了适当的规定，以评估医疗器械中使用的材料的生物相容性，应满足的最低要求。它针对的是那些委托、设计和执行测试或评估动物测试数据的人，这些动物测试旨在评估医疗器械中使用的材料或医疗器械本身的生物相容性。 本文件提出了建议并提供了指导，旨在促进未来进一步减少使用的动物总数，改进试验方法以减少或消除动物的疼痛或痛苦，以及用其他不需要动物试验的科学有效方法代替动物试验。 本文件适用于对活体脊椎动物（非人类）进行的试验，以确定材料或医疗器械的生物相容性。 本文件不适用于对无脊椎动物和其他低等动物进行的试验；也不适用于对取自已实施安乐死的脊椎动物的分离组织和器官进行的测试（与物种、来源、健康状况以及护理和住宿相关的规定除外）。

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.