ISO/FDIS 11135

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

General information

Current stage: 50.00 Effective date: 12 maj 2026

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

Scope

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.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 11135:2014

PUBLISHED
ISO 11135:2014/Amd 1:2018

NOW

IN_DEVELOPMENT
ISO/FDIS 11135
50.00 Final text received or FDIS registered for formal approval
12 maj 2026