AAMI - TIR24971
Medical devices - Guidance on the application of ISO 14971
inactive
| Organization: | AAMI |
| Publication Date: | 1 January 2013 |
| Status: | inactive |
| Page Count: | 27 |
scope:
This Technical Report 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.
Document History
January 1, 2020
Medical devices— Guidance on the application of ISO 14971
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be...
January 1, 2013
Medical devices - Guidance on the application of ISO 14971
This Technical Report 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...
TIR24971
January 1, 2013
Medical devices - Guidance on the application of ISO 14971
This Technical Report 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...