scope:

General

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

NOTE-For purposes of this standard, health care facilities refers to 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 small steam sterilizers, including cassette sterilizers, that have a volume less than or equal to 56.63 liters (2 ft³), have automatic controls, and provide means of controlling 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 table-top steam sterilizers that are intended for use in health care facilities. The criteria defined in this standard might be useful to health care personnel and purchasing authorities in the acquisition process. However, the standard is not intended to provide guidelines for receiving-inspection testing or steam sterilization procedures in health care facilities.

Exclusions

Manually controlled steam sterilizers (i.e., sterilizers without software control) and all other sterilizers not covered in 1.2 are excluded from the scope of this standard.

NOTE-Minimum labeling and performance requirements for large steam sterilizers (those having a volume greater than 56.63 liters [2 ft³]) are covered in ANSI/AAMI ST8. Guidelines for steam sterilization procedures in health care facilities, including typical steam sterilization cycle parameters, are provided in ANSI/AAMI ST79.