ISO/TR 24971:2013
Medical devices — Guidance on the application of ISO 14971
Reference number
ISO/TR 24971:2013
Edición 1
2013-07
© ISO 2024
Retirada
Retirada (Edición 1, 2013)

Resumen

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.

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 2013-07
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 1
    Número de páginas
     : 12
  • Comité Técnico :
    ISO/TC 210
    ICS :
    11.040.01 
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