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:
Explore our medical device testing services
Clinical Evaluation
We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.
Medical devices bioburden testing
Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.
Disinfection products for medical devices
We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.
Explore our laboratory areas
Microbiology Laboratory
We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.
Test chambers
We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.
Chemistry Laboratory
Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials
development.
