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Norm
ISO 10993-12:2002
Issue date: 2002 12 11
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2003-06)
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 me...
Withdrawn: 2007 10 31
Publisher:
International Organization for Standardization
Format:
Digital | 15 Pages
Language:
English
Currently valid:
ICS
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.
ISO 10993-12:2021
2021 01 20
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
ISO 10993-12:2012
2012 06 29
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
ISO 10993-12:2007
2007 10 31
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corr...
Norm
ISO 10993-12:2002
2002 12 11
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corr...
Norm
↖
ISO 10993-12:1996
1996 09 05
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
Norm
Issue date :
2007 10 31
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2008-02)
