FprEN ISO 11135

Name: FprEN ISO 11135
Brand: CEN
SKU: FprEN ISO 11135
Price: 134.14 EUR
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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11135:2026) FprEN ISO 11135

Publication date: Jun 26, 2025

General information

Current stage: 45.99 Dispatch of FV draft to CCMC Jun 24, 2026

Originator: CEN

Owner: CEN/TC 204 Sterilization of medical devices

Type: European Norm

ICS: 11.080.01 Sterilization and disinfection in general

Buying

Status: Draft

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 legislation

Legislation related to this standard

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

Legislation 2017/745

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

Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 11135:2014

PUBLISHED
EN ISO 11135:2014/A1:2019

NOW

IN_DEVELOPMENT
FprEN ISO 11135
45.99 Dispatch of FV draft to CCMC
Jun 24, 2026