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ISO/TR 24971:2013

Medical devices -- Guidance on the application of ISO 14971

General information

Withdrawn from 16.06.2020
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.06.2020
Main
19.06.2013
Main
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.

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