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
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.