The new revision of Annex 1 now specifies the test criteria that shall be used for Thermal Validation of sterilisation by heat cycles.
In this article we look at one such criteria called maximum temperature range.
It is a check that all sensors in the test are within both the minimum and maximum temperature limits for the sterilisation cycle.
For sterilisation to be effective the load must be held at or above the defined minimum temperature and for the defined minimum time (exposure time). There is also a need to limit the maximum temperature being applied to avoid potential deterioration of the load items. Therefore, the range of temperatures recorded throughout the thermal validation study must be reported and compared to the allowed limits.
The minimum and maximum temperature recorded by every sensor during the exposure time must be confirmed to be within the allowable temperature range and the overall minimum and maximum also reported.
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