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11 Starting and running a program
11.2 Batch documentation evaluation
Pursuant to DIN EN 285 (October 1996).
Temperature
The sterilization temperature range must have the sterilizing temperature as its
lower limit and a temperature that is 3 K higher as its upper limit.
Partial load, thermoelectrical
The equilibration time must not exceed 15 seconds.
The temperature measured above the standard testing pack, during the plateau
time must not exceed the temperature measured at the reference site within the
sterilizing chamber by more than 5 K during the first 60 seconds or by more than
2 K during the remaining time.
During the holding time, the temperatures measured at the reference site within the
sterilizing chamber and in the nominal centre of the standard test pack:
- must not lie outside the sterilizing temperature range,
- must not vary by more than ≤ 1.5 K,
- must not differ by more than 2 K.
The holding time must not be less than 15 minutes at 121 °C, 10 minutes at 126°C
or 3 minutes at 134°C.
Full load, thermoelectrical
The equilibration time must not exceed 15 seconds.
At the end of the equilibration time, the temperatures measured at the reference
site within the sterilizing chamber, in the nominal geometric centre of the standard
test pack and below the upper cloth layer of the standard test pack placed inside
the test load must all be within the sterilizing temperature range.
During the holding time, the temperatures measured at the reference site within the
sterilizing chamber and in the nominal centre of the standard test pack:
- must not lie outside the sterilizing temperature range,
- must not vary by more than ≤ 1.5 K,
- must not differ by more than 2 K.
The holding time must not be less than 15 minutes at 121 °C, 10 minutes at 126°C
or 3 minutes at 134°C.
66
Thermo Scientific
50112712_082007_GB
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