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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Withdrawn: 2010 01 01
Publisher:
Austrian Standards International
Format:
Digital | 20 Pages
Language:
German | English
Optionally co-design standards:
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).
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ISO 10993-1:2003
Issue date : 2003 07 28
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