ISO 10993-12:2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Hardcopy , PDF
English, French
31-10-2007
09-04-2025
ISO 10993-12:2007 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 the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:
- 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 10993-12:2007 is not applicable to materials or devices containing live cells.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN ISO 10993-12:2009 | Identical |
| BS EN ISO 10993-12:2007 | Identical |
| UNE-EN ISO 10993-12:2008 | Identical |
| AS ISO 10993.12-2004 | Identical |
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