ISO 10993-2:2006 医疗装置生物学评定.第2部分：动物平安要求

标准编号：ISO 10993-2:2006

中文名称：医疗装置生物学评定.第2部分：动物平安要求

英文名称：Biological evaluation of medical devices — Part 2: Animal welfare requirements

发布日期：2006-07

标准范围

ISO 10993-2:2006针对委托、设计和执行试验或评估动物试验数据的人员，这些动物试验旨在评估用于医疗器械的材料或医疗器械本身的生物相容性。它规定了最低要求，以确保并证明已为动物试验中使用的动物的福利做出了适当规定，以评估医疗器械中使用的材料的生物相容性。ISO 10993-2:2006还提出了建议和指南，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，并用其他不需要动物试验的科学有效手段取代动物试验。它适用于在活体脊椎动物（人类除外）上进行的试验，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.

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