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ISO 13485:1996

Withdrawn

Withdrawn

View Superseded by

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

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

12-26-1996

Withdrawn date

04-09-2025

Superseded by

ISO 13485:2003

US$96.00
Excluding Tax where applicable
Summarise this standard

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.

DocumentType
Standard
Pages
10
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

Standards Relationship
AS ISO 13485-2002 Identical
CEI UNI EN ISO 13485:2002-06 Identical
BS EN ISO 13485:2001 Identical
UNE-EN ISO 13485:2001 Identical
JIS Q 13485:1998 Identical

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A newer version of this standard is available.

US$96.00
Excluding Tax where applicable