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EN ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11135:2014

Publication date:   Sep 19, 2014

General information

60.60 Standard published   Jul 16, 2014

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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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

93/42/EEC

Medical devices

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90/385/EEC

Active implantable medical devices

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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

Harmonized/Supporting
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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

Harmonized/Supporting
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Life cycle

PREVIOUSLY

WITHDRAWN
CEN ISO/TS 11135-2:2008

WITHDRAWN
CEN ISO/TS 11135-2:2008/AC:2009

WITHDRAWN
EN ISO 11135-1:2007

NOW

PUBLISHED
EN ISO 11135:2014
60.60 Standard published
Jul 16, 2014

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 11135:2014/A1:2019

REVISED BY

IN_DEVELOPMENT
prEN ISO 11135