Standards Development

Scope

1.1 Inclusions

This document specifies requirements for the development, validation and routine control of an ethylene oxide (EO) 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.

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.

Although the scope of this document is limited to medical devices, the requirements and guidance can be applicable to other health care products.

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, which are addressed in ISO 22442-3.

1.2.2 This document does not detail a specified requirement for designating a medical device as sterile.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.

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 its reaction products.

NOTE For further information see ISO 10993‑7.