Another important Medical Device Standard has just been revised — ISO 10993-12, “Biological evaluation of medical devices – Part 12: Sample preparation and reference materials.” The new 4th edition cancels and replaces the 3rd edition (ISO 10993-12:2007), which has been technically revised. The new release is available now from Document Center Inc.
The ISO 10993-12:2012 specifies methods of sample preparation and provides requirements and guidance for the selection of reference materials for the biological evaluation of medical devices.
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,
- and 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.
If you need additional information on the rest of the series, review our complete list of the ISO 10993 series standards on Biological evaluation of Medical Devices.
All ISO standards are available on our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re happy to assist you with all your standards requirements.
