ISO 10993-1:2003

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

Publication date: 28 korr 2003

95.99 Withdrawal of Standard 13 tet 2009

General information

Current stage: 95.99 Effective date: 13 tet 2009

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Gjuha: anglisht

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Statusi: Shfuqizuar

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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WITHDRAWN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WITHDRAWN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
13 tet 2009

REVISED BY

WITHDRAWN
ISO 10993-1:2009