1.1 医疗器械可能对神经系统的结构和/或功能产生不利影响。在本指南中，这些不良反应被定义为神经毒性。本指南提供了有关神经毒性测试方法的背景信息和建议。本指南应结合实践使用 F748 ，并且在需要进行神经毒性测试以评估接触中枢和/或外周神经系统组织或脑脊液（CSF）的医疗器械时可能会有所帮助。 注1: 这些结果 体外 和 体内 测试可能与实际的人类反应不一致。 1.2 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.3 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 本指南的目的是推荐一组生物测试，这些测试可以在实践中推荐的测试之外使用 F748 . 本指南旨在检测由接触神经组织的医疗设备引起的神经毒性。 4.2 对于新材料、具有可能影响神经组织反应的不同制造方法的既定材料或用于新神经组织应用的材料，应考虑测试建议。 4.3 化学表征可用于评估在类似神经组织应用中具有临床使用历史的材料的相似性。

1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748 , and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact central and/or peripheral nervous system tissue or cerebral spinal fluid (CSF). Note 1: The results of these in vitro and in vivo tests may not correspond to actual human response. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 The objective of this guide is to recommend a panel of biological tests that can be used in addition to the testing recommended in Practice F748 . This guide is designed to detect neurotoxicity caused by medical devices that contact nervous tissue. 4.2 The testing recommendations should be considered for new materials, established materials with different manufacturing methods that could affect nervous tissue response, or materials used in new nervous tissue applications. 4.3 Chemical characterization can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.