ANSI AAMI ST33:1996 (2000) pdf download.Guidelines for the selection and use of reusable rigid container systems for ethylene oxide sterilization and steam sterilization in health care facilities.
NOTE—For the purpose of this recommended practice, “health care facilities” means hospitals, nursing homes, extended-care facilities, free-standing surgical centers, clinics, and medical and dental offices. For convenience, the term “hospital” sometimes is used; in all instances, the term encompasses all other health care facilities.
1.2 Inclusions
This recommended practice specifically addresses
a) cleaning and decontamination of container systems;
b) preparation and assembly of container systems with instruments;
c) loading container systems into the sterilizer and unloading them from the sterilizer;
d) matching the container system to the appropriate sterilization method and cycle (gravity-displacement steam sterilization, dynamic-air-removal steam sterilization, ethylene oxide IEOI sterilization);
e) quality assurance;
f sterile storage;
g) transport of’ container systems within and between health care facilities;
h) aseptic presentation of container systems;
1) process performance.
Definitions of terms, a bibliography, and annexes containing supplementary information also are provided in this recommended practice.
1.3 Exclusions
This recommended practice does not cover
a) labeling or design criteria for container systems or the quality and performance capabilities of the filters;
b) the use of container systems for packaging items other than instrument sets or procedural trays;
c) ongoing sterility assurance programs;
d) rigid, protective organizing cases that require wrapping prior to sterilization;
e) flash sterilization; any other method of sterilization not noted in 1.2.
NOTE—For guidelines on steam sterilization, see AAMI (1 994b) ANSI/AAMI ST8- 1993 and AAMI (1 996a) ANSI/AAMI ST37-1996. For guidelines on EO sterilization, see AAMI (1992) ANSI/AAMI ST4I-1992. For safety and performance criteria for steam sterilizers and ethylene oxide sterilizers, see AAMI (1 994b) ANSI/AAMI ST8-1993 and AAMI (1993) ANSIIAAMI ST24-1992, respectively. For information on the use of a container system with sterilization technologies other than ethylene oxide and saturated steam, consult the container manufacturer.
2 Definitions
For the purposes of this recommended practice, the following definitions apply:
2.1 absorbent towel: All-cotton towel having a plain weave with only the warp yarns tightly twisted.
2.2 aerator, ethylene oxide: Machine designed to speed up the removal of ethylene oxide residuals from
sterilized items by subjecting them to warm, circulating air.
2.3 biological indicator (BI): Sterilization process monitoring device consisting of a standardized, viable
population of microorganisms (usually bacterial spores) known to be resistant to the mode of sterilization being
monitored.
NOTE—Biological indicators are intended to demonstrate whether the conditions were adequate to achieve
sterilization. A negative biological indicator does not prove that all items in the load are sterile or that they were all exposed to adequate sterilization conditions.ANSI AAMI ST33 pdf download.