For the biological assessment of gas pathways in medical devices, the pure application of DIN EN ISO 10993-1 can lead to tests of dubious benefit and failure to recognise potential hazards. The DIN EN ISO 18562 series of standards therefore offers an alternative for the biological assessment of gas pathways of a medical device and its parts or accessories that are intended for ventilation or the supply of substances via the airways of a patient. DIN EN ISO 18562-1 provides a basis for assessment and testing within a risk management process.
We offer the following methods for biocompatibility evaluation of breathing gas pathways in healthcare applications based on DIN EN ISO 18562-1 in the accredited area and/or under GLP:
- DIN EN ISO 18562-2: Tests for particle emissions
- DIN EN ISO 18562-3: Tests for emissions of volatile organic compounds (VOCs)
- DIN EN ISO 18562-4: Tests for leachable substances in condensates