scope:

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.

It does not cover the quality assurance system which is essential to control all stages of manufacture which include the sterilization process.

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.

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.

It does not cover analytical methods for determining levels of residual ethylene oxide and/or its reaction products (see ISO 10993-7).

It does not cover products that are affected adversely by ethylene oxide or by other ethylene oxide residuals produced in the processes described.