IFU 14466 Rev A
5
Sterilization
The following sterilization parameters have been validated for instruments in a tray, wrapped or
unwrapped.
Note: Invuity endorses the following sterilization parameters per AAMI recommendations for
wrapped instruments and container with combined weight of less than 25 lbs [11.3 kg].
Steam Sterilization Parameters
Description
Gravity
Displacement
Pre-Vacuum
Temperature
132°C
2
(270°F)
132-138°C
(270-280°F)
Cycle Time
15 minutes
1
3-8 minutes
1
Dry Time
45 minutes
30 minutes
1
Maximum exposure time may be extended to 18 minutes.
2
Maximum sterilization temperature may be extended to 137 °C.
Note: Do not use Sterrad® or other sterilization processes that contain chlorine (bleach) or
enzymatic solutions.
The final responsibility for verification of sterilization techniques lies directly with the hospital. To
ensure the efficacy of hospital processing, all cycles and methods should be verified for different
sterilization chambers, wrapping methods, and/or various loading configurations.
International sterilization parameters are per the following standards:
•
Australia/New Zealand per AS/NZS 4187
•
Netherlands per Field Standard for Loaner Instruments, Rev 03.02, April 2008
•
Europe and the United Kingdom per EN ISO 17664
•
Canada per CSA ISO 17664
Storage
Store Sterilization Trays in a clean, dry area.
