ANSI AAMI ST55-2016 pdf download
ANSI AAMI ST55-2016 pdf download.Table-top steam sterilizers
4.4.3 Sterilizer temperature control
The control-set temperature shall be selected and the control shall function so that the chamber temperature during the exposure time remains within ±3 9°C(or ±6 2F) and -0 °C (or -0 9F) of the selected sterilization exposure temperature at defined locations within the chamber (see 5.4.3). Any mechanism provided to the operator to select the sterilization exposure temperature shall be marked in, or adjustable to, increments no larger than 19°C (or 2 9F) throughout the entire range from 5 9°C (or 10 9F) above to 5 °C (or 10 9F) below the sterilization exposure temperature. The sterilizer control system shall initiate sterilization exposure timing when the selected sterilization exposure temperature has been achieved. If the chamber temperature falls below or exceeds the sterilization exposure temperature, the sterilizer control shall abort the cycle and treat this as a sterilization fault condition. See 4.4.7.
4.4.4 Sterilizer exposure timer
The sterilizer shall be equipped with a reset timer for timing sterilization exposure. The timer shall automatically reset in the event of an electrical power failure unless the controls can determine that the temperature has not dropped below the limit established in 4.4.3. The timer shall have a minimum accuracy of±5 % of the maximum possible value. See also 4.4.3 and Annex B.
4.4.5.1 Chamber pressure indicator
The sterilizer shall be equipped with a mechanical gauge, digital indicator, or other device for indicating the pressure within the chamber. The means of indicating pressure shall be accurate to within±3 % of the fullscale value. In the positive-pressure region, the indicator shall have graduations or a resolution of 6.9 kPa absolute (1 psig) or less. The scale shall be graduated for a minimum fll-scale range of 5 atmospheres absolute (506.6 kPa [73.5 psial]).
4.4.5.2 Jacket pressure indicator
If the sterilizer is equipped with a jacket, an indicator that displays jacket pressure shall be provided. This indicator, or another means of indicating that the unit is ready to run a cycle, shall be readily visible to and readable by the operator. If a mechanical gauge is used, it shall be accurate to within±3 % of the full-scale value. If a digital indicator is used, it shall be accurate to within 6.9 kPa (1 psi). Each graduation or increment of resolution shall be 2 psi or less. The scale shall be graduated for a minimum full-scale range of 5 atmospheres absolute (506.6 kPa [73.5 psia]), or as required by the ASME Boiler and pressure vesse/ code, whichever is greater.
4.4.7 Strilization fault conditions
If a fault in sterilization conditions occurs during cycle operation, the sterilizer shall provide visible and audible indications of the fault. If the sterilization fault results in aborting or terminating a cycle in progress, the indication of the fault (audible, visual or both) must continue until the operator acknowledges the cycle fault; acknowledgement means a specified action is required by the operator to clear the indication of the fault. As specified in 4.3.3, the controls shall allow the sterilization cycle to be terminated safely.
4.4.8 Cycle documentation
For each cycle, the following minimum information shall be documented on the sterilizer printout or electronic record if the sterilizer is equipped with a printer or electronic recording device:
a) the cycle parameters selected for that cycle;
b) the date and time the cycle started;
c) the cycle number and assigned sterilizer identification number;
d) the elapsed time at each designated phase change, with temperature and pressure indicated; and
e) the total cycle time.
It is acceptable for the printout to provide space for users to manually document information that is not automatically recorded on the printout.
In addition, space shall be provided for an approval signature and other load-dependent information. Deviations from selected cycle parameters or the functional parameters of the cycle program shall be displayed during their occurrence, and the time of such events shall be recorded.
