ISO 10993-12:2012 PDF Download
Standard EN Sample
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Also Known As:
SKU919279617
Published by
International Organization for Standardization
ISO
Publication Date2012-07
Pages CountPages28
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.
Details
History and complementary documents
History
| Edition | 4 |
| ICS Codes | 11.100.20 - Biological evaluation of medical devices |
| Language(s) | English |
| File Size | 245.8 KB |
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