Medical Device Testing
Emmace focuses on the characterisation of medical devices that are in indirect contact with the airways. Both ISO accredited tests, according to ISO 18562:2024, and technical tests are provided to clients in this field. We are also interested to develop new and specially adapted methods jointly together with the client.
Testing of Medical Devices in In-direct Contact with the Breathing Pathways
Our main focus is on biocompatibility evaluation of medical devices that are included in set-ups that can release particulate matters (particles), volatile organic substances (very volatile organic substances), and condensate volume.
Medical Device Testing
- ISO 18562 Testing for Medical Respiratory Devices: secure your regulatory approval:
- ISO 18562-2 Determination of Particulate Matter (PM)
- ISO 18562-3 Identification and Quantification of Volatile Organic Substances (VOS)
- ISO 18562-4 Condensate testing: ensuring safety in breathing gas pathways
- ISO 27427 Nebulizer testing: validate your device performance
- ISO 13320 Laser diffraction testing: real-time aerosol & droplet sizing
We also have methods for quantification of isocyanates (accredited) and aldehydes emitting from medical devices. More information is found under each specific analysis abowe.
