scope:

General

This standard applies to steam sterilizers that are intended for use in hospitals and other health care facilities and that have a volume greater than 56.63 liters (2 cubic feet [ft³]).

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 standard; 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 steam sterilizers that have a volume greater than 56.63 liters (2 ft³), have automatic controls, generally use an external steam source (but may also have an integral electric boiler), and provide a means for automatically recording time and temperature. Definitions of terms and normative references are also included, as well as an annex explaining the rationale for the provisions of the standard and other informative annexes.

NOTE-This standard is intended primarily for use by manufacturers in the performance and design qualification of steam sterilizers intended for use in health care facilities. The criteria defined in this standard may be useful to health care personnel and purchasing authorities in the acquisition process. However, the standard is not intended to provide guidelines for hospital receiving inspection testing or for steam sterilization procedures in health care facilities.

Exclusions

Sterilizers that generate steam inside the sterilizing chamber, washer-sterilizers, and all other sterilizers not covered in 1.2 are excluded from this standard. Likewise, this standard does not cover installation acceptance testing, sterilization procedures, machine-operator requirements, or sterility assurance testing in health care facilities. Also, this standard does not address sterilizer performance with reusable rigid sterilization container systems and other containment devices.

NOTE-Minimum labeling and performance requirements for small steam sterilizers (those that are 56.63 liters [2 ft³] or less in volume) are covered in ANSI/AAMI ST55; guidelines for the use of such sterilizers are provided in ANSI/AAMI ST79. ANSI/AAMI ST79 also covers inhospital steam sterilization procedures and quality control, as well as the selection and use of containment devices intended for use in steam sterilization.