Reference number
ISO/TR 24971:2013
© ISO 2025
Technical Report
ISO/TR 24971:2013
Medical devices — Guidance on the application of ISO 14971
Edition 1
2013-07
Withdrawn
Withdrawn (Edition 1, 2013)

Abstract

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.

General information

  • Status
     : Withdrawn
    Publication date
     : 2013-07
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 12
  • Technical Committee :
    ISO/TC 210
    ICS :
    11.040.01 
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