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 devices testing in biological systems in accordance with one or more parts of the ISO 10993 series.
Specifically, this part of ISO 10993 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 this part of ISO 10993 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.
ISO 10993-12:2002 history
2021ISO 10993-12:2021 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
2012ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
2007ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
2002ISO 10993-12:2002 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
1996ISO 10993-12:1996 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials