标准号：ISO 10993-12-2007
实施状态：作废
中文名称：医疗器械的生物学评估.第12部分:样品制备和参考材料
英文名称：Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
发布日期：2007-11
被替代标准：ISO 10993-12-2012
代替标准：ISO 10993-12-2002;ISO/FDIS 10993-12-2007
采用标准：DIN EN ISO 10993-12-2008,IDT;DIN EN ISO 10993-12-2009,IDT;ANSI/AAMI/ISO 10993-12-2007,IDT;BS EN ISO 10993-12-2007,IDT;BS EN ISO 10993-12-2009,IDT;EN ISO 10993-12-2007,IDT;EN ISO 10993-12-2009,IDT;prEN ISO 10993-12-2008,IDT;NF S99-501-12-2009,IDT;NF S99-512-2008,IDT;SN EN ISO 10993-12-2008,IDT;SN EN ISO 10993-12-2009,IDT;OENORM EN ISO 10993-12-2008,IDT;OENORM EN ISO 10993-12-2009,IDT;OENORM EN ISO 10993-12-2009,IDT;PN-EN ISO 10993-12-2008,IDT;PN-EN ISO 10993-12-2009,IDT;PN-EN ISO 10993-12-2009,IDT;UNE-EN ISO 10993-12-2008,IDT;UNE-EN ISO 10993-12-2009,IDT;GOST R ISO 10993-12-2009,IDT
起草单位：ISO/TC 194
标准简介：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.
文件格式：PDF
文件大小：227.79KB
文件页数：24
（以上信息更新时间为：2019-11-22）
ISO 10993-12-2007 医疗器械的生物学评估.第12部分_样品制备和参考材料.pdf
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