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.
15.2.3.3 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:
1.1. 4 preconditioning pulses
1.2. Steam cycle at 134°C / 273°F for 3 minutes
1.3. 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:
1.1. 4 preconditioning pulses
1.2. Steam cycle at 134°C / 273°F for 4 minutes
1.3. 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:
1.1. 4 preconditioning pulses
1.2. Steam cycle at 134°C / 273°F for 5 minutes
1.3. 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.
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