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ISO/TR 24971:2013

Medical devices — Guidance on the application of ISO 14971

Jun 19, 2013
95.99 Withdrawal of Standard   Jun 16, 2020

General information

95.99     Jun 16, 2020

ISO

ISO/TC 210

Technical Report

11.040.01  

English  

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Scope

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.

Life cycle

NOW

WITHDRAWN
ISO/TR 24971:2013
95.99 Withdrawal of Standard
Jun 16, 2020

REVISED BY

PUBLISHED
ISO/TR 24971:2020