Due to the significant risk that materials of animal or human origin may transfer pathogenic viruses or prions, all products containing such materials must be evaluated in accordance with the ISO 22442 series of standards, in order to establish their virological safety. Based on the classification rules of the Medical Device Directive, such devices are classified in Class III (except contact to intact skin) and require a comprehensive design and safety review by the notified body.

Should the need arise to use medical devices repeatedly or by different persons, suitable cleaning, disinfection and sterilization processes must be applied in order to minimize the risk of viral transfer from person to person. Therefore, new cleaning and disinfection procedures must verify their virucidal efficacy. In particular cases it may even be necessary to investigate the elimination/inactivation of prions responsible for transmissible spongioform encephalopathia (TSE).

What we do:

  • Antiviral Activity of Disinfectants (Suspension Test)
  • Virological Testing of Final Products
  • Validation of Virus Reduction or Inactivation during Manufacturing
  • Tests for Antiviral Activity of Test Substances

Contact us for a free proposal on testing related to ISO 22442.