ISO 10993-12:2012 PDF
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Open preview (PDF)Biological evaluation of medical devices — Part 12: Sample preparation and reference materialsBiological evaluation of medical devices — Part 12: Sample preparation and reference materials
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 20
- Publication date:
- June 29, 2012
- Edition:
- ISO IS 10993 edition 4 version 1
- ICS:
- 11.100.20
ISO 10993-12:2012 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, ISO 10993-12:2012 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. ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
Technical details
- Technical committee
- ISO/TC 194 - Biological and clinical evaluation of medical devices
- SKU
- ISO 10993-12:2012
