ISO 10993-12 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
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ISO 10993-12 Document Information:
Title
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
International Organization for Standardization
Publication Date:
Nov 15, 2007
Scope:
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.
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