5. After the drying process package immediately for sterilization in packaging suitable for vapor
sterilization. Ensure that packaging stays dry before autoclaving.
Note: Articles must be individually single pouched in a qualified pouch (e.g. Cardinal Health self-
sealing pouch CAT# 92713). Each of the non-critical devices in-scope are thermostable and
have been validated for steam sterilization.
14.2.4.2 Sterilization options
The recommended sterilization method is steam sterilization by autoclave. The following validated
cycles are suitable for sterilization:
Option A:
1. Set the autoclave with the following parameters
• 4 preconditioning pulses
• Steam cycle at 134°C / 273°F for 3 minutes
• Dry cycle for 30 minutes
2. Individually single pouch the exhalation membrane and membrane holder separately.
3. Autoclave the exhalation membrane and membrane holder using the cycle parameters in Step 1
above.
Option B:
1. Set the autoclave with the following parameters
• 4 preconditioning pulses
• Steam cycle at 134°C / 273°F for 4 minutes
• Dry cycle for 30 minutes
2. Individually single pouch the exhalation membrane and membrane holder separately.
3. Autoclave the exhalation membrane and membrane holder using the cycle parameters in Step 1
above.
Option C:
1. Set the autoclave with the following parameters:
• 4 preconditioning pulses
• Steam cycle at 134°C / 273°F for 5 minutes
• Dry cycle for 30 minutes
2. Individually single pouch the exhalation membrane and membrane holder separately.
3. Autoclave the exhalation membrane and membrane holder using the cycle parameters in Step 1
above.
14.2.4.3 Duration of use
The exhalation membrane and membrane holder must be replaced after 30 sterilization cycles and also in
case of any detected defect that is affecting the accessory performance.
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