Sterilization Temperature Bands
| Sterilization Period | Minimum Temperature | Maximum Temperature |
|---|---|---|
Thermometric Test Terminology
| Indicated Value | Indicated values are shown by a permanently installed dial or other visual indicator fitted to the machine. |
| Recorded Value | Recorded values are shown by a permanently installed recording device fitted to the machine. |
| Measured Value | Measured values are provided through test instrumentation such as test recorders and pressure gauges that are temporarily installed to the machine during testing. |
| Holding Time | Holding time is the period of a cycle where all measured temperatures within the load and chamber within the appropriate sterilization/disinfection band during the thermometric test. |
| Equilibration Time | Equilibration time is the difference in time between the chamber and the load reaching the appropriate sterilization/disinfection band during the thermometric test. |
| Plateau Period | The plateau period is the time between start of equilibration time and the end of the holding time. |
| Automatic Control Test | During the plateau period determined from the recorded chamber temperature: Maximum of 2°C difference between indicated chamber temperature and recorded chamber temperature. Maximum of 0.1 bar difference between indicated chamber pressure and recorded chamber pressure. |
| Verification of Calibration of Sterilizer Instruments | During the holding time: Indicated temperature and recorded temperature are within 1°C of the measured drain temperature. Indicated pressure and recorded pressure are within 0.05 bar of the measured pressure. |
| Thermometric Test | During the plateau period, the temperature measured in the chamber free space does not exceed the temperature measured in the drain by more than 5°C. After the first minute of the plateau period, the temperature measured within the jaws of the forceps is within 1°C of the temperature measured in the active chamber discharge. The holding time determined from the measured temperatures is not less than the appropriate sterilization band. At the end of the cycle the temperature of any water left in either the chamber or reservoir is less than the boiling point of water at local atmospheric pressure. |
Thermometric Test: Porous Load Sterilizer
| Automatic Control Test | During the plateau period determined from the recorded chamber temperature: Maximum of 2°C difference between indicated chamber temperature and recorded chamber temperature. Maximum of 0.1 bar difference between indicated chamber pressure and recorded chamber pressure. |
| Verification of Calibration of Sterilizer Instruments | During the holding time: Indicated temperature and recorded temperature are within 1°C of the measured drain temperature. Indicated pressure and recorded pressure are within 0.05 bar of the measured pressure. |
| Thermometric Test | During the plateau period, the temperature measured above the test pack does not exceed the temperature measured in the drain by more than 5°C for the first 60 seconds and 2°C for the remaining period. The equilibration time determined from the measured temperature does not exceed 15 seconds for chambers up to 800 litres or 30 seconds for larger chambers. The holding time determined from the measured temperatures is not less than the appropriate sterilization band. During the holding time the temperatures measured in the active chamber discharge and the centre of the test pack do not fluctuate by more than +/- 1°C and do not differ from one another by more than 2°C. |
