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     : Withdrawn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
  • Edition
     : 1
    Number of pages
     : 12
  • Technical Committee
     : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  • ICS
     :
    11.040.01 Medical equipment in general

Life cycle

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