Efficacy testing - Test or Validation of cleaning and Disinfection Methods

Helle Stendahl Andersen

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Efficacy testing - Test or Validation of cleaning and Disinfection Methods

When surfaces and equipment are cleaned and disinfected in the medical field, customers and authorities can in some cases demand that the efficacy of the cleaning and/or disinfection procedure is tested.

Such a test will document that the equipment meets the applicable requirements and that there is no risk of infection.

It is recommended to carry out cleaning and disinfection in two separate procedures. In many cases cleaning will be sufficient, while in other cases there will be a need for subsequent disinfection and possibly sterilization.

Within the medical field, equipment can be divided into three categories, and there are different requirements to how they should be cleaned, disinfected or sterilized.

  • Non-critical equipment: Often only requires cleaning

o Equipment that is only in contact with intact skin or not in contact with patients

  • Semi-critical equipment: Requires cleaning and disinfection

o Equipment that is in contact with non-intact skin or intact non-sterile mucous membranes without penetration of tissue

  • Critical equipment: Requires cleaning, disinfection and sterilization

o Equipment that is in contact with sterile cavities and sterile tissues
o Surgical or other invasive procedures


How can Danish Technological Institute help you?
Danish Technological Institute i.a. offers to:

  • Help define requirements to cleaning and disinfection
  • Prepare test protocols and implement tests
  • Prepare documentation for customers or authorities in Danish, English or German
  • Prepare procedure for future cleaning procedures
  • Prepare procedure for future disinfection procedures