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 can be applicable to other health care products.

Cross References:
ISO 11140-1
ISO 11138-2:2006
ISO 11737-2
ISO 11737-1:2018
ISO 10993-7
ISO 10012
ISO 11138-1:2006
ISO 22442-2
IEC 61010-2-040
ISO 14001
ISO 14971
TS 11139:2006
ISO 9000:2005
ISO 22442-1
ISO 9001
ISO 14937:2009
TS 16775
ISO 15883
ISO 22442-3
NZS 4187
ISO 10993
ISO 11607-2
AAMI ST41:1999
EN 556-1
IEC 90003
IEC 61010-1
ISO 11607-1
AAMI ST67:2006
ISO 14161:2009
ISO 14040
ISO/IEC Guide 99:2007
AAMI TIR16:2009
ISO 17664:2017
AAMI TIR15:2009
AAMI TIR28:2009


Incorporates the following:
Amendment, November 2019; Corrigendum, January 2015