Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
ISO 10993-12:2002 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series.
Specifically, ISO 10993-12:2002 addresses:
- test material selection;
- selection of representative portions from a device;
- test sample preparation;
- experimental controls;
- selection of and requirements for reference materials; and,
- preparation of extracts.
The applicability of ISO 10993-12:2002 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.