Biocompatibility of breathing gas pathways in medical applications
The biological evaluation of medical devices according to ISO 10993 does not adequately address breathing gas pathways. ISO 18562 considers additional specific requirements to enable an appropriate biological assessment of breathing gas pathways.
Testing according to the ISO 18562 series of standards is critical to ensure the biocompatibility of medical devices that have gas-mediated contact with a patient's respiratory tract. This series of standards defines tests and specific requirements for the emission of particles, volatile organic substances and soluble substances in condensate.
The tests according to ISO 18562 are relevant for the following products:
- Therapeutic medical devices: ventilators, anaesthesia workstations, incubators.
- Products for treatment of gases: nebulisers, humidifiers, filters for ventilators.
- Products for gas transmission: ventilation tubes, masks, Y-pieces.
Our experienced team will support you in planning and carrying out the necessary tests. Contact us to create a customised test plan for your product and ensure the safety of your medical devices.
