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naSRPS EN ISO 11135:2024

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025)

General information

45.99     Jun 24, 2026

50.20    Sep 30, 2026

ISS

Z076

European Norm

11.080.01  

English  

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Life cycle

NOW

PROJECT
naSRPS EN ISO 11135:2024
45.99 Dispatch of FV draft to CCMC
Jun 24, 2026

Related project

Adopted from prEN ISO 11135 IDENTICAL

Adopted from ISO/FDIS 11135 IDENTICAL