We offer a wide range of tests for determining the efficacy of disinfectant products to be used in medical environments to disinfect medical devices. These products must be correctly classified following the rules of Medical Device Regulations as class IIa, IIb or class III. Annex 9 of the 93/42 – classification of medical devices as referenced in the MDR – rule 15 covers substances and other equipment intended to be used in medical environments to disinfect medical devices: All devices intended specifically used for disinfecting medical devices must be classified as Class IIa. All devices specifically intended to disinfect invasive medical devices must be classified as Class IIb device.
Specifically for disinfectant wipes, we offer the following tests:
