Numéro de référence
ISO/TR 24971:2013
Rapport technique
ISO/TR 24971:2013
Dispositifs médicaux — Directives relatives à l'ISO 14971
Edition 1
2013-07
Annulée
ISO/TR 24971:2013
59587
Annulée (Edition 1, 2013)

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

  •  : Annulée
     : 2013-07
    : Annulation de la Norme internationale [95.99]
  •  : 1
  • ISO/TC 210
    11.040.01 
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