ISO/IEC Guide 63:2012
Guide to the development and inclusion of safety aspects in International Standards for medical devices
Reference number
ISO/IEC Guide 63:2012
Edición 2
2012-01
© ISO 2024
Retirada
Retirada (Edición 2, 2012)

Resumen

ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.

ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 2012-01
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 2
    Número de páginas
     : 21
  • Comité Técnico :
    ISO/TMBG
    ICS :
    11.020.01 
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