a)
Apparatus and instruments used for testing should be so
installed as not to hinder accurate operation. The test
instruments should be calibrated at least annually to assure
laboratory accuracy.
b)
Each surgical pack should consist of 10 bed sheets, each
folded 6 times, and held together with cotton cord, muslin
strips, or commercial, pressure-sensitive, surgical-pack
tape. Each pack should contain 3 spore-test strips
inoculated with Bacillus stearothermophilus dried spore
population adjusted to survive 132 C (270 F) for 20
seconds and to be killed when exposed to 132 C (270 F) for
two minutes. The strips should be placed within each pack
as follows:
(1)
One at the front between the first and second sheets.
(2)
One in the center between the fifth and sixth sheets.
(3)
One at the rear between the ninth and tenth sheets.
c)
Each instrument tray should contain a hand towel covering
the bottom of the tray, and 100 metal surgical instruments
including retractors, forceps and hemostats. A spore strip
should be placed amid the instruments in one of the tray
load. Each tray of instruments shall then be wrapped with
two layers of muslin and weight between 5.4 kg and 6.3 kg
(12 and 14 pounds).
d)
Each utensil pack should contain metal hospital utensils in
the following quantities:
1
solution basin, 350 mm (14 inch)
1
solution basin, 300 mm (12 inch)
1
emesis basin
1
solution cup
A hand towel should be placed between each utensil. The
utensil nearest the center of one pack shall contain a spore
strip. The utensils should be wrapped with a double
thickness of muslin, forming the test pack, and held
together by cotton cord, muslin strips, or
commercial-pressure-sensitive surgical tape.
4)
Sterilizing and Drying Efficiency Test:
a)
Fabric and hard goods loads should be weighted prior to
their cycles. The weights should be recorded.
b)
Place the fabric pack into the sterilizer chamber with the
flat side down. Operate the sterilizer to sterilize and dry
the load, and return the chamber to approximately atmosphere
pressure. Within 1 minute following completion of the drying
phase of cycle, remove the pack from the chamber and record
it's weight.
c)
Place the instrument trays and utensil packs into the
sterilizer chamber and operate the sterilizer to sterilize
and dry the load. Return the chamber to approximately
atmospheric pressure. Within 1 minute following completion
of the drying cycle, remove the trays and packs from the
chamber and record their weight.
5)
Test Results:
a)
The total times required to sterilize and dry the fabric and
hard goods loads should not exceed those specified in the
contract specifications and/or the manufacturer's
standards.
11710-7
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