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CEI UNI EN ISO 13485:2002-06

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Quality systems Medical devices Specific requirements for the application of EN ISO 9001 (revision of EN 46001:1996)

Published date

01-06-2002

Superseded date

20-09-2025

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The standard specifies, together with UNI EN ISO 9001, the requirements relating to the quality system pertaining to the design/development, production and, where relevant, installation and maintenance of medical devices.

Committee
CT 62
DocumentType
Standard
PublisherName
Comitato Elettrotecnico Italiano
Status
Superseded
SupersededBy

Standards Relationship
ISO 13485:1996 Identical

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