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ISO 13485:1996

Quality systems — Medical devices — Particular requirements for the application of ISO 9001

Publication date:   Dec 26, 1996

95.99 Withdrawal of Standard   Sep 18, 2006

General information

95.99 Withdrawal of Standard   Sep 18, 2006

ISO

ISO/TC 210 Quality management and corresponding general aspects for medical devices

International Standard

03.100.70   Management systems | 11.040.01   Medical equipment in general

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Scope

Specifies, in conjunction with the application of ISO 9001, the quality system requirements for the design/development and, when relevant, installation and servicing of medical devices.

Life cycle

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WITHDRAWN
ISO 13485:1996
95.99 Withdrawal of Standard
Sep 18, 2006

REVISED BY

WITHDRAWN
ISO 13485:2003