ISO TR 24971:2013 ED1

Medical devices -- Guidance on the application of ISO 14971

Publication date:   Jun 19, 2013

General information

99.60 Withdrawal effective   Jun 19, 2020

IEC

TC 62/SC 62A

Technical Report

11.040.01   Medical equipment in general

Buying

  Revised

PDF - €76.23

  English   Russian  



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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WITHDRAWN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 ED1
99.60 Withdrawal effective
Jun 19, 2020

REVISED BY

PUBLISHED
ISO TR 24971:2020 ED2