CEI UNI EN ISO 13485 : 2012
Current
The latest, up-to-date edition.
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
Hardcopy , PDF
English
01-01-2012
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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 |
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