DIN EN ISO 10993-12:2008 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.
DIN EN ISO 10993-12:2008 history
2021DIN EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021
2019DIN EN ISO 10993-12:2019 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019); German and English version prEN ISO 10993-12:2019
2012DIN EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012
1970DIN EN ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
2008DIN EN ISO 10993-12:2008 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2007