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CEI
CEI UNI EN ISO 13485 : 2012

CEI UNI EN ISO 13485 : 2012

Current

Current

The latest, up-to-date edition.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

Publisher

Comitato Elettrotecnico Italiano

European foreword
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         90/385/EEC (as amended)
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC (as amended)
Annex ZC (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         98/79/EC

FASC 15307.

Committee
CT 62
DevelopmentNote
Supersedes CEI EN 46001 (01/2003) Classificazione CEI 62-229. Supersedes CEI UNI EN ISO 13488. (08/2011) Italian translation of 6ED 2016 Issued on 01/01/2017. (02/2017) 5ED 2012 Edition is valid until 31-03-2019. ERRATA 2017 Issued on 01/11/2017 is only available in English. (01/2018)
DocumentType
Standard
Pages
90
PublisherName
Comitato Elettrotecnico Italiano
Status
Current
Supersedes

Standards Relationship
UNI CEI EN ISO 13485 : 2012 Identical
ISO 13485:2016 Identical
EN ISO 13485:2016/AC:2018 Identical

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PDF - English
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