Generic Unwrapped Instruments & Utensils Sterilization Cycle

Indicated Values are shown by a permanently installed dial or other visual indicator fitted to the sterilizer.

Recorded Values are shown by a permanently installed recording device fitted to the sterilizer.

Measured Values are provided through test instrumentation such as test recorders and pressure gauges that are temporarily installed to the sterilizer during testing.

Holding Time is the period of a sterilization cycle where all measured temperatures within the load and chamber are within the appropriate sterilization band during the thermometric test. 

Equilibration Time is the difference in time between the chamber and the load reaching the appropriate sterilization band during the thermometric test.

Plateau Period is the time between start of equilibration and the end of the holding time.

During The Plateau Period Determined From The Recorded Chamber Temperature:

• Maximum of 2.0°C Difference between Indicated and Recorded Chamber Temperature
  
• Maximum of 0.1 Bar Difference between Indicated and Recorded Chamber Pressure

During The Holding Time:

• Indicated & Recorded Temperatures are within 1.0°C of the Measured Drain Temperature
• Indicated & Recorded Pressure are within 0.05 Bar of the Measured Pressure

A continuous supply of saturated steam is required for steam sterilization and for humidification in certain EO sterilizers. Too high a level of non-condensable gases will prevent the attainment of sterilizing conditions; too little moisture carried in suspension may allow the steam to become superheated during expansion into the chamber, while excess moisture may cause damp loads.

For all these tests, the steam should be sampled from the steam service pipe to each sterilizer. The measurements are taken during a period of maximum steam demand, when steam is first admitted to the
sterilizer chamber.

Superheat Test
This test is used to demonstrate that the amount of moisture in suspension with steam from the service supply is sufficient to prevent the steam from becoming superheated during expansion into the chamber.

Dryness Test
The accurate measurement of the percentage of moisture content in the steam is difficult, and the traditional methods where constant steam flow is required are not suitable for sterilizers. This test should be regarded not as measuring the true content of moisture in the steam, but as a method by which the provision of acceptable steam quality can be demonstrated.

Non-Condensable Gas Test
This test is used to demonstrate that the level of non-condensable gases in the steam will not prevent the attainment of sterilization conditions in any part of the load.

Steam Quality Test Requirements (Unwrapped Instruments & Utensils)

Superheat:	< 250 DegC
Dryness Fraction for Metal Loads:	> 0.95
Non-Condensable Gas:	< 3.5%

Saturated Steam Tables can be found here