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Norm
ISO 10993-12:2007
Issue date: 2007 10 31
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2008-02)
ISO 10993-12:2007 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Withdrawn: 2012 06 29
Publisher:
International Organization for Standardization
Format:
Digital | 17 Pages
Language:
English
Currently valid:
ICS
ISO 10993-12:2007 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 the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:
- 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 10993-12:2007 is not applicable to materials or devices containing live cells.
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 :
2012 06 29
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
