Arthrex AR-3210-0006, Instructions For Use Manual

Page: 26 / 384

18
Sterilization
EN
7.3 Low-temperature sterilization
Perform sterilization with the following low-temperature sterilization processes:
STERRAD® • STERRAD® 100S
• STERRAD® NX
• STERRAD® 100 NX
STERIS® • STERIS® V-PRO® 1 Low Temperature Sterilization System: Standard Cycle
• STERIS® V-PRO® 1 Plus Low Temperature Sterilization System: Lumen or Non
Lumen Cycle
• STERIS® V-PRO® maX Low Temperature Sterilization System: Lumen, Non Lu-
men or Flexible Cycle
• STERIS® V-PRO® 60 Low Temperature Sterilization System: Lumen or Non Lu-
men Cycle
7.4 Storage
Store sterile items dry and dust-free. Observe all national and local requirements
for the storage of sterile items.
7.5 Sterilization Validation
The microbiological validation of the steam sterilization was carried out with the
following device:
• Autoclave: EURO-Selectomat® (MMM GmbH)
• Sterilization type: Fractionated pre-vacuum steam sterilization
• Parameters: 132 °C (270 °F), 2 minutes temperature holding time
Microbiological validation of the STERRAD® system was carried out with the
STERRAD® 100S system.
The microbiological validation of the STERIS® system was carried out with the
STERIS® V-PRO® maX Low Temperature Sterilization System.
NOTE!
The instructions above have been validated as SUITABLE by the manufacturer of
the medical product for the preparation of a medical device for reprocessing. The
person carrying out the reprocessing is responsible for ensuring that the actually
carried out reprocessing with the used equipment, materials, and staff in the re-
processing facility has the desired results. This usually requires validation and
routine monitoring of the process. Any deviation from the provided instructions
should be evaluated carefully by the person handling the reprocessing for effec-
tiveness and possible adverse consequences.