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Norm
ÖNORM EN ISO 10993-1
Issue date: 2009 08 15
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Withdrawn: 2010 03 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 21 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 patient s body, nor does it cover biological hazards arising from any mechanical failure.
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 :
2010 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Norm
Issue date :
2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
