ISO TR 24971:2013
Collections
Normes internationales IEC
Date de publication
juin 2013
Nombre de pages
12 p.
Référence
ISO TR 24971:2013
Numéro de tirage
1
ISO TR 24971:2013
juin 2013
Rapport technique
Annulée
Medical devices -- Guidance on the application of ISO 14971
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
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Résumé
Medical devices -- Guidance on the application of ISO 14971
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.
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.
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Norme remplacée par
(1)
ISO TR 24971:2020
juin 2020
Rapport technique
En vigueur
Dispositifs·médicaux — Directives relatives à l'ISO 14971
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