CEI UNI EN ISO 13485:2002-06
Superseded
Superseded
View Superseded by
Quality systems Medical devices Specific requirements for the application of EN ISO 9001 (revision of EN 46001:1996)
Available format(s)
Hardcopy , PDF
Language(s)
Italian
Published date
06-01-2002
Publisher
Superseded date
09-20-2025
Superseded by
Excluding Tax where applicable
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
|
| Pages |
18
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 13485:1996 | Identical |
Summarise