scope:

General

This recommended practice provides guidelines for decontamination and dry heat sterilization procedures used in dentists' and physicians' offices, laboratories, ambulatory care clinics, and other health care facilities. These guidelines are intended to promote the assurance of sterility by identifying the special considerations that apply to this method of sterilization and by providing recommendations on the proper use of table-top dry heat sterilization processing equipment. This recommended practice also covers facility design considerations, personnel considerations, work practices, and other variables that affect sterility assurance.

Inclusions

This recommended practice specifically addresses the following:

a) functional and physical design criteria for work areas;

b) staff qualifications, education, and other personnel considerations;

c) preparation and packaging of devices (wrapped and unwrapped methods);

d) sterilization procedures;

e) sterile storage and distribution;

f) installation, care, and maintenance of table-top dry heat sterilizers; and

g) quality control.

Definitions of terms, a bibliography, and annexes providing supplementary information about dry heat sterilization are also included.

Exclusions

This recommended practice does not cover

a) construction and performance criteria for table-top dry heat sterilizers (see ANSI/AAMI ST50);

b) conduction-type or radiation-type dry heat sterilization processes

c) table-top sterilization processes that use sterilizing agents other than dry heat (such as ethylene oxide, steam, unsaturated chemical vapor, or peracetic acid); or

d) reprocessing of devices labeled for single use only.