ISO 10993-12:2021 医疗器械的生物学评价 第12部分：样品制备和标准材料

标准编号：ISO 10993-12:2021

中文名称：医疗器械的生物学评价 第12部分：样品制备和标准材料

英文名称：Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

发布日期：2021-01

标准范围

本文件规定了主要根据ISO 10993系列的一个或多个部分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程序的要求和指导。具体而言，本文件涉及以下内容:-测试样本选择；-从医疗器械中选择代表性部分；-试样制备；-实验对照；-标准物质的选择和要求；-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设备组件有关。ISO 10993-18涵盖了化学特性的提取。第7、8、9、10条[第10条除外]。3.5和10.3.11 b）和11可用于化学特性的萃取。C.1至C.4中给出的信息也可能是相关的。

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.

标准预览图