Abstract
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.
-
Status: WithdrawnPublication date: 2002-12
Corrected version (en): 2003-06 -
Edition: 2Number of pages: 15
-
- ICS :
- 11.100.20 Biological evaluation of medical devices
Life cycle
-
Previously
WithdrawnISO 10993-12:1996
-
Now
-
Revised by
WithdrawnISO 10993-12:2007
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)