Borrador del Comité
ISO/CD 11135
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Reference number
ISO/CD 11135
Edition 3
Borrador del Comité
ISO/CD 11135
90088
El comité está revisando un borrador.
Reemplazará ISO 11135:2014

Resumen

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Informaciones generales

  •  : En desarrollo
    : CD aprobado para su registro como DIS [30.99]
  •  : 3
  • ISO/TC 198
    11.080.01 
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