NS-EN ISO 10993-12:2021
医疗器械生物学评价 第12部分：样品制备和参考材料（ISO 10993-12:2021）

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

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标准号

NS-EN ISO 10993-12:2021

发布

2021年

发布单位

SCC

当前最新

NS-EN ISO 10993-12:2021

 

 

适用范围

  Full Description ADOPTED_FROM:EN ISO 10993-12:2021 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.

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