DIN EN ISO 10993-12:2008
医疗器械的生物评定.第12部分:样品制备和参考材料

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2007

作废

DIN EN ISO 10993-12:2008 发布历史

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 the ISO 10993 series. Specifically this part of ISO 10993 addresses: -- 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 materials or devices containing live cells.

DIN EN ISO 10993-12:2008由德国标准化学会 DE-DIN 发布于 2008-02-01，于 2009-08-01 废止。

DIN EN ISO 10993-12:2008 在中国标准分类中归属于: C30 医疗器械综合。

DIN EN ISO 10993-12:2008的历代版本如下：

• 2021年 DIN EN ISO 10993-12:2021
• 2019年 DIN EN ISO 10993-12:2019
• 2012年 DIN EN ISO 10993-12:2012 医疗器械的生物学评价. 第12部分:样品制备与参照样品 (ISO 10993-12-2012); 德文版本EN ISO 10993-12-2012
• 2008年 DIN EN ISO 10993-12:2008 医疗器械的生物评定.第12部分:样品制备和参考材料

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标准号

DIN EN ISO 10993-12:2008

发布

2008年

发布单位

德国标准化学会

 

 

代替标准

DIN EN ISO 10993-12:2009

适用范围

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 the ISO 10993 series. Specifically this part of ISO 10993 addresses: -- 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 materials or devices containing live cells.

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