ISO 10993-12:2002
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices Part 12: Sample preparation and reference materials
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
09-08-2018
English, French
12-11-2002
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.
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