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prEN ISO 11135

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023)

General information
Base Documents
prEN ISO 11135; ISO/DIS 11135:2024
Directives or regulations

Standard history

prEN ISO 11135
1.1 Inclusions
This document 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 andexperience.
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 single-use medical devices. Health care facilities, on the other hand, handle and process both new medical devices and reusable medical devices of different types 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 document, alternative approaches and guidance specific to health care facilities are identified as such.
NOTE 4 EO gas and its mixtures are effective sterilants for medical devices that are sensitive other modalities such as moist heat and ionizing radiation
NOTE 5 Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products.
NOTE 6 See Annex A for guidance on Clauses 1 to 12.
1.2 Exclusions
1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.2 This document does not detail a specified requirement for designating a medical device as sterile.
NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See for example EN 556–1 or ANSI/AAMI ST67.
1.2.3 This document does not specify a quality management system for the control of all stages of production of medical devices
NOTE The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this document to have a full quality management system during manufacture or reprocessing. The necessary elements are referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
National and/or regional regulations for the provision of medical devices can require the implementation of a full quality management system and the assessment of that system by a third party.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
NOTE EO is toxic, flammable and explosive. National or regional regulations exist in some countries concerning safety requirements for the handling of EO and for premises in which EO is used. Refer to the Bibliography for further information on safety.
1.2.5 This document does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber.
NOTE See ISO 14937 for validation of these types of EO processes.
1.2.6 This document does not cover analytical methods for determining levels of residual EO and/or its reaction products.
NOTE 1 For further information see ISO 10993-7.
NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for the level of EO residues present on or in medical devices.
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