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SSH 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)

Nov 27, 2015

General information

60.60     Nov 27, 2015

DPS

DPS/KT 316

European Norm

11.080.01  

English  

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Published

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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 directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Directive 90/385/EEC
93/42/EEC

Medical devices

Directive 93/42/EEC
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
Directive 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

Harmonized
Directive 2017/746

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 11135-1:2007

WITHDRAWN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

WITHDRAWN
DS CEN ISO/TS 11135-2:2008

NOW

PUBLISHED
SSH EN ISO 11135:2014
60.60 Standard published
Nov 27, 2015

Related project

Adopted from EN ISO 11135:2014