Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

1 Scope This part of ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE 2 See for example ISO 22442-1, ISO 22442-2 and ISO 22442-3. This part of ISO 11135 does not detail a specified requirement for designating a medical device as sterile. NOTE 3 Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See for example EN 556-1 or ANSI/AAMI ST67. This part of ISO 11135 does not specify a quality management system for the control of all stages of production of medical devices. NOTE 4 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 part of ISO 11135 to have a complete quality management system during manufacture or reprocessing, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see in particular Clause 4). National and/or regional regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party. This part of ISO 11135 does not specify requirements for occupational safety associated with the design and operation of ethylene oxide sterilization facilities. NOTE 5 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist. NOTE 6 Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling ethylene oxide and for premises in which it is used. This part of ISO 11135 does not cover sterilization by injecting ethylene oxide or mixtures containing ethylene oxide directly into individual product packages, or continuous sterilization processes. CAN/CSA-Z11135-1-09 ISO 11135-1:2007(E) 2 © ISO 2007 – All rights reserved This part of ISO 11135 does not cover analytical methods for determining levels of residual ethylene oxide and/or its reaction products. NOTE 7 For further information see ISO 10993-7. NOTE 8 Attention is drawn to the possible existence of regulations specifying limits for the level of ethylene oxide residues present on or in medical devices and products.