ISO/TR 24971:2013
Withdrawn
View Superseded by
Medical devices — Guidance on the application of ISO 14971
Hardcopy , PDF
English, Russian
06-19-2013
04-09-2025
ISO/TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard to understand the role of international product safety and process standards in risk management, develop the policy for determining the criteria for risk acceptability, incorporate production and post-production feedback loop into risk management, differentiate between "information for safety" and "disclosure of residual risk", and evaluate overall residual risk.
| Committee |
ISO/TC 210
|
| DocumentType |
Technical Report
|
| Pages |
12
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| SIS-ISO/TR 24971:2014 | Identical |
| PD ISO/TR 24971:2013 | Identical |
| NEN NPR ISO/TR 24971 : 2013 | Identical |
| NBR ISO/TR 24971 : 2014 | Identical |
| AAMI ISO TIR 24971 : 2013 | Identical |
| AAMI ISO TIR 24971 : 2013 : R2016 | Identical |
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