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Norm
ÖNORM EN ISO 10993-12
Issue date: 2005 03 01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)
This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the
preparation of samples and the selection of reference materials ...
Withdrawn: 2008 03 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 23 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 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, this part of ISO 10993 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 this part of ISO 10993 to absorbable materials, materials that polymerize in situ,
tissue-engineered medical products and materials of biological origin should be carefully evaluated.
ÖNORM EN ISO 10993-12
2021 09 15
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO ...
Norm
ÖNORM EN ISO 10993-12
2012 10 01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO ...
Norm
ÖNORM EN ISO 10993-12
2009 09 15
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO ...
Norm
ÖNORM EN ISO 10993-12
2008 03 01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO ...
Norm
ÖNORM EN ISO 10993-12
2005 03 01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO ...
Norm
↖
ÖNORM EN ISO 10993-12
1997 02 01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO ...
Norm
Norm
Issue date :
2007 06 01
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
Norm
Issue date :
2009 03 15
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01, not included)
Norm
Issue date :
1997 12 11
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
Issue date :
2000 11 30
Medical devices — Application of risk management to medical devices
Norm
Issue date :
2008 03 01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
Norm
Issue date :
2002 12 11
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2003-06)
