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Norm
ISO 10993-12:2012
Ausgabedatum: 2012 06 29
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for me...
ZURÜCKGEZOGEN: 2021 01 20
Herausgeber:
International Organization for Standardization
Format:
Digital | 20 Seiten
Sprache:
Englisch
Aktuell Gültig:
ICS
ISO 10993-12:2012 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 ISO 10993. Specifically, ISO 10993-12:2012 addresses the following:
- 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 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products 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
Ausgabedatum :
2021 01 20
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
