I.S. EN ISO 14971:2007
Superseded
View Superseded by
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
Hardcopy , PDF
English
01-01-2007
10-10-2018
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 a process for a manufacturer to identify the hazards associated with
medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated
risks, to control these risks, and to monitor the effectiveness of the controls.
| DocumentType |
Standard
|
| Pages |
96
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 14971:2007 | Equivalent |
| UNE-EN ISO 14971:2007 | Equivalent |
| DIN EN ISO 14971:2007-07 | Equivalent |
| BS EN ISO 14971:2007 | Equivalent |
| ISO 14971:2007 | Equivalent |
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