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

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