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ISO 10993-1:2003

Biological evaluation of medical devices — Part 1: Evaluation and testing

Jul 28, 2003
95.99 Withdrawal of Standard   Oct 13, 2009

General information

95.99     Oct 13, 2009

ISO

ISO/TC 194

International Standard

11.100.20  

English  

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Scope

ISO 10993-1:2003 describes
the general principles governing the biological evaluation of medical devices;the categorization of devices based on the nature and duration of their contact with the body;the selection of appropriate tests.
It 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.
Other parts of ISO 10993 cover specific tests.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-1:1997

NOW

WITHDRAWN
ISO 10993-1:2003
95.99 Withdrawal of Standard
Oct 13, 2009

REVISED BY

WITHDRAWN
ISO 10993-1:2009