GSO ISO 10993-12:2016
醫療器械生物學評價 第12部分：樣品制備和標準物質

Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

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標準號

GSO ISO 10993-12:2016

發布

2016年

發布單位

GSO

當前最新

GSO ISO 10993-12:2016

 

 

適用范圍

This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following: — test sample selection; — selection of representative portions from a device; — test sample preparation; — experimental controls; — selection of, and requirements, for reference materials; — preparation of extracts. This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

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