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Norm
ÖNORM EN ISO 10993-12
Issue date: 2021 09 15
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testin...
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§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 33 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
— test sample selection;
— selection of representative portions from a medical device;
— test sample preparation;
— experimental controls;
— selection of, and requirements for, reference materials;
— preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant
ÖNORM EN ISO 10993-12
2021 09 15
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO ...
Norm
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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 :
2021 01 20
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials