Estado : Retirada

Resumen

ISO/TR 15499:2016 is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993‑1. It does not add to, or otherwise change, the requirements of ISO 10993‑1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 2016-12
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 2
    Número de páginas
     : 15
  • Comité Técnico :
    ISO/TC 194
    ICS :
    11.100.20 
  • RSS actualizaciones

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. TC
  5. ISO/TC 194
  6. ISO/TR 15499:2016