International Standard
IEC 62366-1:2015
Medical devices — Part 1: Application of usability engineering to medical devices
Reference number
IEC 62366-1:2015
Edición 1
2015-02
© ISO 2024
International Standard
Vista previa
No disponible en español
Publicado (Edición 1, 2015)
Esta norma se revisó y confirmó por última vez en 2021. Por lo tanto, esta versión es la actual.
Esta norma tiene 1 modificaciones.

IEC 62366-1:2015

Formato
Idioma
CHF 300
Convertir Franco suizo (CHF) a tu moneda

Resumen

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2015-02
    Etapa
    : Norma Internacional confirmada [90.93]
  • Edición
     : 1
    Número de páginas
     : 96
  • Comité Técnico :
    ISO/TC 210
    ICS :
    11.040.01 
  • RSS actualizaciones

 Modificaciones

Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.

Amendment 1

Edición 2020

Formato
Idioma
CHF 115
Convertir Franco suizo (CHF) a tu moneda

Ciclo de vida

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Tienda
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.040
  7. 11.040.01
  8. IEC 62366-1:2015