DS/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

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Harmonized under:
  • 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 (Text with EEA relevance. )

  • 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 (Text with EEA relevance. )

Harmonized standards:


1.1 Inclusions
This International Standard 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.
NOTE 1 – Among the similarities are the common need for quality systems, staff training, and proper safety measures.
The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization.
NOTE 2 – Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience. The primary function of the health care facility is to provide patient care; medical device reprocessing is just one of a myriad of activities that are performed to support that function.
NOTE 3 – In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large numbers of similar medical devices that have been produced from virgin material. Health care facilities, on the other hand, must handle and process both new medical devices and reusable medical devices of different descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International Standard, alternative approaches and guidance specific to health care facilities are identified as such.
NOTE 4 – EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisture-sensitive medical devices that cannot be moist heat sterilized.
NOTE 5 – Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.

Number of pages: 100

Published: 2014-09-18

Date of approval: 2014-09-12

International relationships : EN ISO 11135:2014 IDT ISO 11135:2014 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: M257655



  • CEN/TC 204
  • ISO/TC 198
  • ISO/TC 198/WG 1

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