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ISO/DIS 11135:2025

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

Summary

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.

Notes

30.99 : CD approuvé pour enregistrement comme DIS

Technical characteristics

Publisher International Organization for Standardization (ISO)
Publication Date 09/18/2025
Edition 3
Page Count 110
EAN ---
ISBN ---
Weight (in grams) ---