AAMI 11135

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Sterilization of health care products – Ethylene oxide – Requirements fordevelopment, validation and routine control of a sterilization process formedical devices
2014 Edition, 2014

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  • Revision:2014 Edition, 2014
  • Published Date:January 2014
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:95
  • ANSI Approved:Yes
  • DoD Adopted:No
  • Inclusions

    This International Standard specifies requirements for thedevelopment, validation, and routine control of an ethylene oxidesterilization process for medical devices in both the industrialand health care facility settings, and it acknowledges thesimilarities and differences between the two applications.

    NOTE 1 Among the similarities are the common need for qualitysystems, staff training, and proper safety measures. The majordifferences relate to the unique physical and organizationalconditions in health care facilities, and to the initial conditionof reusable medical devices being presented for sterilization.

    NOTE 2 Health care facilities differ from medical devicemanufacturers in the physical design of processing areas, in theequipment used, and in the availability of personnel with adequatelevels of training and experience. The primary function of thehealth care facility is to provide patient care; medical devicereprocessing is just one of a myriad of activities that areperformed to support that function.

    NOTE 3 In terms of the initial condition of medical devices,medical device manufacturers generally sterilize large numbers ofsimilar medical devices that have been produced from virginmaterial. Health care facilities, on the other hand, must handleand process both new medical devices and reusable medical devicesof different descriptions and with varying levels of bioburden.They are therefore faced with the additional challenges ofcleaning, evaluating, preparing, and packaging a medical deviceprior to sterilization. In this International Standard, alternativeapproaches and guidance specific to health care facilities areidentified as such.

    NOTE 4 EO gas and its mixtures are effective sterilants that areprimarily used for heat- and/or moisture-sensitive medical devicesthat cannot be moist heat sterilized.

    NOTE 5 Although the scope of this International Standard islimited to medical devices, it specifies requirements and providesguidance that can be applicable to other health care products.


    This International Standard does not specify requirements forthe development, validation, and routine control of a process forinactivating the causative agents of spongiform encephalopathies,such as scrapie, bovine spongiform encephalopathy, andCreutzfeldt-Jakob disease. Specific recommendations have beenproduced in particular countries for the processing of materialspotentially contaminated with these agents.

    NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3.

    This International Standard does not detail a specifiedrequirement for designating a medical device as sterile.

    NOTE Attention is drawn to national or regional requirements fordesignating medical devices as "sterile". See for example EN 556–1or ANSI/AAMI ST67.

    This International Standard does not specify a qualitymanagement system for the control of all stages of production ofmedical devices.

    NOTE The effective implementation of defined and documentedprocedures is necessary for the development, validation, androutine control of a sterilization process for medical devices.Such procedures are commonly considered to be elements of a qualitymanagement system. It is not a requirement of this InternationalStandard to have a full quality management system duringmanufacture or reprocessing. The necessary elements are normativelyreferenced at appropriate places in the text (see, in particular,Clause 4). Attention is drawn to the standards for qualitymanagement systems (see ISO 13485) that control all stages ofproduction or reprocessing of medical devices. National and/orregional regulations for the provision of medical devices mightrequire the implementation of a full quality management system andthe assessment of that system by a third party.

    This International Standard does not specify requirements foroccupational safety associated with the design and operation of EOsterilization facilities.

    NOTE 1 For further information on safety, see examples in theBibliography. National or regional regulations may also exist.

    NOTE 2 EO is toxic, flammable, and explosive. Attention is drawnto the possible existence in some countries of regulations givingsafety requirements for handling EO and for premises in which it isused.

    This International Standard does not cover sterilization byinjecting EO or mixtures containing EO directly into packages or aflexible chamber.

    NOTE See ISO 14937 for these types of EO processes.

    This International Standard does not cover analytical methodsfor determining levels of residual EO and/or its reactionproducts.

    NOTE 1 For further information see ISO 10993-7.

    NOTE 2 Attention is drawn to the possible existence of nationalor regional regulations specifying limits for the level of EOresidues present on or in medical devices.