scope:

General

This standard applies to automatic, general-purpose ethylene oxide (EO) sterilizers and EO sterilant sources that are intended for use in hospitals and other health care facilities.

NOTE-For purposes of this standard, "health care facilities" means hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices. For convenience, the term "hospital" is sometimes used in this recommended practice; in all instances, this term should be taken to encompass all other health care facilities.

Inclusions

This standard covers minimum labeling, safety, performance, and testing requirements for EO sterilizers that are intended for general-purpose use in health care facilities and that have automatic controls. For purposes of this standard, a "general-purpose" EO sterilizer is defined as a chamber-type sterilization system that injects water vapor to adjust humidity during the cycle, generally employs excursions in pressure from atmospheric levels, and is intended to sterilize a wide range of medical items. This standard also covers labeling, product composition, and container requirements for EO sterilant sources. Referee test methods and definitions of terms are also included, as well as an annex explaining the rationale for the provisions of the standard, annexes containing supplemental technical information, and a bibliography.

Exclusions

This standard does not apply to EO sterilizers that release EO inside the package containing the wrapped items to be sterilized. Also excluded from the scope of this standard are the performance and use of industrial EO sterilizers, the performance and use of EO aerators and other ventilation systems, and inhospital sterilization procedures and routine sterility assurance. The provisions of this standard do not obviate the need for careful attention in the hospital environment to the control of occupational exposure to EO, including area and environmental monitoring.

NOTE-For detailed recommendations concerning safe and effective EO sterilization in health care facilities, see AAMI (1999). Recommendations concerning industrial EO sterilization are provided in AAMI (1994).