prEN ISO 11135 rev

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices prEN ISO 11135 rev

General information

Current stage: 10.99 New project approved Jul 23, 2024

Originator: CEN

Owner: CEN/TC 204 Sterilization of medical devices

Type: European Norm

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

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 11135:2014

PUBLISHED
EN ISO 11135:2014/A1:2019

NOW

IN_DEVELOPMENT
prEN ISO 11135 rev
10.99 New project approved
Jul 23, 2024