Résumé

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.


Informations générales 

  • État actuel
     : Annulée
    Date de publication
     : 2013-07
  • Edition
     : 1
  • Comité technique
     : ISO/TC 210 Management de la qualité et aspects généraux correspondants des dispositifs médicaux
  • ICS
     :
    11.040.01 Matériel médical en général

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