标准摘要
[中文适用范围]： 本文件主要根据 ISO 10993 系列的一个或多个部分规定了主要在生物测试系统中进行医疗器械测试的样品制备和参考材料选择的要求并提供了指导。 具体来说，本文件涉及以下内容： ——测试样本的选择； ——从医疗器械中选择代表性部分； ——测试样品的制备； ——实验对照； ——参考材料的选择和要求； ——提取物的制备。 本文件不适用于活细胞，但可能与含有活细胞的组合产品的材料或医疗器械组件相关。 ISO 10993-18 涵盖了用于化学表征的提取。 第 7、8、9、10 条 [10.3.5 和 10.3.11 b) 除外] 和 11 可适用于化学表征的提取。 C.1 至 C.4 中给出的信息也可能是相关的。 [外文原描述]： This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following: — test sample selection; — selection of representative portions from a medical device; — test sample preparation; — experimental controls; — selection of, and requirements for, reference materials; — preparation of extracts. This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells. Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.
英文名称Biological evaluation of medical devices — Part 12: Sample preparation and reference materials