M00001501
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ISO 10993-12 4th Edition, July 1, 2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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Availability date: 07/13/2021
Description / Abstract:
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 ISO
10993. Specifically, this part of ISO 10993 addresses the
following:
— 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 live cells, but can
be relevant to the material or device components of combination
products containing live cells.