ISO 10993-12:2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by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, Russian
29-06-2012
09-04-2025
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.
| Committee |
ISO/TC 194
|
| DevelopmentNote |
Supersedes ISO/DIS 10993-12. (07/2012)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 10993-12:2012-10 | Identical |
| ANSI/AAMI/ISO 10993-12:2012 | Identical |
| GOST ISO 10993-12 : 2015 | Identical |
| NBN EN ISO 10993-12 : 2012 | Identical |
| NEN EN ISO 10993-12 : 2012 | Identical |
| NS EN ISO 10993-12 : 2012 | Identical |
| I.S. EN ISO 10993-12:2012 | Identical |
| PN EN ISO 10993-12 : 2012 | Identical |
| SS-EN ISO 10993-12 : 2012 | Identical |
| BS EN ISO 10993-12:2012 | Identical |
| EN ISO 10993-12:2012 | Identical |
| NF EN ISO 10993-12 : 2012 | Identical |
| DS EN ISO 10993-12 : 2012 | Identical |
| NBR ISO 10993-12 : 2016 | Identical |
| NEN ISO 10993-12 : 2003 | Identical |
| CSA ISO 10993-12 : 98(R2002) | Identical |
| GOST R ISO 10993-12 : 2009 | Identical |
| UNE-EN ISO 10993-12:2013 | Identical |
A newer version of this standard is available.
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