18
Cleaning and Sterilization
Instructions (Continued)
Validated Parameters for Ethylene
Oxide (EtO) Gas Sterilization
100% Ethylene Oxide
CONDITIONING PARAMETERS
Temperature (set point):
55˚C (131˚F)
Humidity:
70% RH
Vacuum (set point):
1.3 psia
Conditioning Dwell Time:
30 minutes
STERILIZATION PARAMETERS
Sterilant:
100% Ethylene oxide
Temperature (set point):
55˚C (131˚F)
Humidity:
70% RH
Humidity Dwell Time:
30 – 45 minutes
EO Gas Concentration:
725 ± 30 mg/L
EO Gas Exposure Time:
120 minutes
(full cycle)
Aeration Time:
12 hours (full cycle)
Aeration Temperature:
51 – 59˚C
(124 – 138˚F)
Steam Sterilization
Caution:
DO NOT sterilize bipolar cords
using immediate-use (flash) steam steriliza-
tion.
1. Place the instruments in a sterilization tray.
2. Wrap with two layers of FDA-cleared poly-
propylene wrap or equivalent material. If
using a sterilization sealed container refer
to the manufacturer’s instructions for use
on using the correct disposable filters for
the indicated sterilization method.
3. KARL STORZ has validated the following
Steam sterilization methods:
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