标准编号：ISO 10993-12:2007
中文名称：医疗器械的生物学评价 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
标准范围
This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in thepreparation of samples and the selection of reference materials for medical device testing in biologicalsystems in accordance with one or more parts of the ISO 10993 series. Specifically this part of ISO 10993addresses:? 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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