ISO 10993-12:2002
Withdrawn
View Superseded by
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Hardcopy , PDF
English, French
12-11-2002
11-02-2025
ISO 10993-12:2002 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series.
Specifically, ISO 10993-12:2002 addresses:
- test material selection;
- selection of representative portions from a device;
- test sample preparation;
- experimental controls;
- selection of and requirements for reference materials; and,
- preparation of extracts.
The applicability of ISO 10993-12:2002 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
15
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| AS ISO 10993.12-2004 | Identical |
| UNE-EN ISO 10993-12:2005 | Identical |
| BS EN ISO 10993-12:2004 | Identical |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.