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Norm
ÖNORM EN ISO 10993-1
Issue date: 2003 12 01
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
This part of ISO 10993 describes
a) the general principles governing the biological evaluation of medical devices;
b) the categorization of devices based on the nature ...
Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 20 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 describes
a) the general principles governing the biological evaluation of medical devices;
b) the categorization of devices based on the nature and duration of their contact with the body;
c) the selection of appropriate tests.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect
contact with the patients body, nor does it cover biological hazards arising from any mechanical failure.
NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).
ÖNORM EN ISO 10993-1
2021 04 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
Norm
ÖNORM EN ISO 10993-1
2011 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
Norm
ÖNORM EN ISO 10993-1
2010 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
Norm
ÖNORM EN ISO 10993-1
2009 08 15
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
Norm
ÖNORM EN ISO 10993-1
2003 12 01
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
Norm
↖
ÖNORM EN ISO 10993-1
1998 07 01
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)
Norm
Norm
Issue date :
2009 08 15
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
Norm
Issue date :
2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
