FLUSHING PUMP OFP
9
4
S
TEAM STERILIZATION (AUTOCLAVING)
Use biological indicators as recommended by your hospital’s policy and follow the sterilizer manufacturer’s instructions,
plus any relevant national and local hospital guidelines and policies. Such guidelines include AAMI TIR12:1994 and
ANSI/AAMI ST79:2006
(USA), EN 285:2006 and HTM 2010:1994 (Europe).
Olympus has validated the efficacy of steam sterilization (autoclaving) in a pre--vacuum sterilizer at the temperatures
and durations in the table below.
Items must be meticulously cleaned and dried prior to sterilization. Thorough cleaning removes both micro--organisms
and organic soil. Failure to adequately clean can decrease the effectiveness of the sterilization procedure.
Always leave space between the packages in the autoclave. If packages are placed too close together, effective
sterilization may be compromised.
Allow the packages to dry within the autoclave using the autoclave’s drying cycle (if applicable) or by opening the door
of the autoclave and allowing the packages to air dry.
Handling a wet package can compromise its sterility.
For details on operation of the autoclave, refer to the instruction manual for the autoclave.
Typical parameters for pre--vacuum autoclaves for wrapped instruments, according to national guidelines/standards:
Minimum Hold
Temperature
Exposure Time
Guideline/Standard Reference
121--124
˚C
15 mins
EN 285: 2006, HTM 2010:1994
126--129
˚C
10 mins
EN 285: 2006, HTM 2010:1994
132
˚C
4 mins
ANSI/AAMI ST79:2006
134--137
˚C
3 mins
ANSI/AAMI ST79:2006, EN 285:2006, HTM 2010:1994
Do not exceed a temperature of 137
˚
C during autoclaving, otherwise equipment damage or accelerated deterioration
may result.
The items included with the OFP that are designated as ‘autoclavable’ may be sterilised using ‘flash’ steam sterilization
cycles utilized for sterilizing unwrapped instruments in emergency situations. Olympus recommends gradual air cooling
after a flash cycle – use of liquids for rapid cooling could result in equipment damage or accelerated deterioration. The
US Association of Operating Room Nurses (AORN) and the US Association for the Advancement of Medical
Instrumentation (AAMI) caution that flash--sterilized items must be used immediately, since sterility assurance of
unwrapped items cannot be maintained.
