I.S. EN ISO 14971:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
Hardcopy , PDF
10-10-2018
English
01-01-2009
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 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 |
98
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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