scope:

General

This standard applies to dry heat (heated air) sterilizers that are intended for use in dental and medical offices, laboratories, ambulatory-care clinics, hospitals, and other health care facilities.

Inclusions

This standard covers minimum labeling, safety, performance, and testing requirements for convection-type dry heat (heated air) sterilizers. Definitions of terms, normative references, and informative annexes (including an annex explaining the rationale for the provisions of this standard ) are also included.

Exclusions

This standard does not cover conduction-type or radiation-type dry heat sterilizers, nor does it provide guidelines for sterilization or sterility assurance procedures within health care facilities.

NOTE-For guidelines on sterilization procedures, sterility assurance procedures, and other aspects of the use of dry heat sterilizers within health care facilities, see ANSI/AAMI ST40.