I.S. EN ISO 13485:2000
Superseded
View Superseded by
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Hardcopy , PDF
English
01-01-2000
10-09-2018
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
This International Standard specifies, in conjunction with ISO 9001, the quality System requirements for the
design/development, production and, when relevant, installation and servicing of medical devices.
| Committee |
TC 210
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
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