ISO/DIS 11135

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

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.

OEN:

ISO

Langue:

English

Code(s) de l'ICS:

11.080.01

Statut:

Brouillon

Date de Publication:

1969-12-30

Numéro Standard:

ISO/DIS 11135