I.S. EN ISO 13485:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Hardcopy , PDF
09-10-2018
English
01-01-2012
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.
Dates of withdrawal of national standards are available from NSAI.
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This International Standard specifies requirements for a quality management system where an organization
needs to demonstrate its ability to provide medical devices and related services that consistently meet
customer requirements and regulatory requirements applicable to medical devices and related services.
| Committee |
TC 210
|
| DocumentType |
Standard
|
| Pages |
95
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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