Dental Testing & Validation - HTM 01-05

HTM 01-05 requires that the equipment used during the decontamination processes are regularly checked by the practice daily and weekly, and a qualified validation engineer either quarterly or annually In accordance with machine manufacturers guidance.

HTM 01-05 introduces the concept of validation to the dental decontamination process and refers to “Parametric product release”. You cannot test the finished decontaminated product without making it unfit for use, so there needs to be a process that allows you to know that the instruments are fit for use.
With a process that is proven to work, using equipment that is proven to work, it can be assumed that the end product is fit for use.
Thus if a process is proven to result in decontaminated instruments and you are able to prove that the process has been replicated in every way, then you can have assurance that the instruments have been decontaminated. This is validation.
The following guidance sections provide information on the HTM 01-05 test schedules required for the equipment used within the decontamination processes, detailing what the test is, what equipment/materials are required to perform the test, along with how to perform the test and who should carry out the testing.