This National Standard of Canada is equivalent to International Standard ISO 11135:1994. 1 Scope 1.1 This International Standard establishes requirements and guidance for
validation and routine control of ethylene oxide sterilization processes for
medical devices. Particular attention is drawn to the need for specific testing for safety,
quality and efficacy, possibly exceeding the requirements of 4.2, which may be
necessary for a specific product. NOTE 2 Although this International Standard has been written for medical
device sterilization, it may also apply to other health care products. 1.2 It does not cover the quality assurance system which is essential to
control all stages of manufacture which include the sterilization process. 1.3 It does not cover operator safety (for further information, see IEc
1010-2). Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the
existence in some countries of regulations laying down safety requirements for
handling ethylene oxide and for premises in which it is used. Attention is drawn to the existence in some countries of statutory regulations
laying down limits for the level of ethylene oxide residues within medical
devices and products. 1.4 It does not cover sterilization either by the technology of injecting
ethylene oxide or its mixtures directly into individual product packages or
continuous sterilization processes. 1.5 It does not cover analytical methods for determining levels of residual
ethylene oxide and/or its reaction products (see ISO 10993-7). 1.6 It does not cover products that are affected adversely by ethylene oxide
or by other ethylene oxide residuals produced in the processes described.