ISO/TR 10993-22:2017 医疗器械生物评价 第22部分：纳米材料指南

标准编号：ISO/TR 10993-22:2017

中文名称：医疗器械生物评价 第22部分：纳米材料指南

英文名称：Biological evaluation of medical devices — Part 22: Guidance on nanomaterials

发布日期：2017-07

标准范围

ISO/TR 10993-22:2017描述了对由纳米材料组成或含有纳米材料的医疗器械进行生物评估的注意事项。此外，本指南还可用于评估非纳米材料制造的医疗设备（部件）降解、磨损或机械处理过程（如医疗设备的原位研磨、抛光）产生的纳米物体。ISO/TR 10993-22:2017包括以下方面的考虑:-纳米材料的表征；-纳米材料测试用样品制备；-从医疗设备中释放纳米物体；-纳米物体的毒代动力学；-纳米材料的生物学评价；-介绍结果；-医疗器械评估中纳米材料的风险评估；-生物评价报告；-医疗器械表面的纳米结构，在医疗器械的工程、制造或加工过程中有意生成。本文件不包括以下内容:-天然和生物纳米材料，只要它们未被设计、制造或加工用于医疗设备；-本体材料中的固有纳米结构；-医疗器械表面的纳米结构，在医疗器械的工程、制造或加工过程中作为意外副产品产生。注:医疗器械表面非故意纳米结构的例子有挤压画线和机加工/工具标记。ISO/TR 10993-22:2017旨在提供一个总体框架，并强调在评估由纳米物体组成、包含和/或生成纳米物体的医疗设备的安全性时需要考虑的重要方面。此外，该文件还指出了在测试纳米材料时发现的几个常见陷阱和障碍，与散装材料或小分子化学物质相比。作为技术报告（TR），本文件代表了与纳米材料相关的当前技术知识。未概述或提供详细的测试协议。本文件可作为包含详细协议的未来文件的基础，重点是纳米材料测试。

ISO/TR 10993-22:2017 describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (e.g. in situ grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials.ISO/TR 10993-22:2017 includes considerations on the:- characterization of nanomaterials;- sample preparation for testing of nanomaterials;- release of nano-objects from medical devices;- toxicokinetics of nano-objects;- biological evaluation of nanomaterials;- presentation of results;- risk assessment of nanomaterials in the context of medical device evaluation;- biological evaluation report;- nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.The following are excluded from this document:- natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;- intrinsic nanostructures in a bulk material;- nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks.ISO/TR 10993-22:2017 is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.

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