Biocompatibility & analysis of medical devices according to ISO 10993 - ISO 18562: Biocompatibility evaluation of breathing gas pathways

Inge  Bondgaard

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Biocompatibility & analysis of medical devices according to ISO 10993 - ISO 18562: Biocompatibility evaluation of breathing gas pathways

Biocompatibility evaluation of breathing gas pathways

Breathing gas pathways of medical devices that are used in healthcare applications have to be assessed according to ISO 18562:2017: Biocompatibility evaluation of breathing gas pathways in healthcare applications.

All breathing pathways must be tested for the emission of particles and volatile organic compounds as well as leachables in condensate. The latter only if this is relevant for the equipment, i.e. if condensate occurs during use.

From mid-2024 a new edition of the standard is expected to be published. This new edition includes an expansion of the parameters tested for. The standard also includes stricter requirements for when it is relevant to test for leachable substances.

This means that it may become relevant to have your breathing pathways which are already tested according to the 2020 edition updated with additional tests so that the equipment meets the new requirements in the new updated version of ISO 18562.


How can Danish Technological Institute help you with biocompatibility evaluation of breathing gas pathways

We can test the following breathing gas pathways of medical devices:

  • According to ISO 18562-2: Tests for emissions of particulate matter
  • According to ISO 18562-3: Tests for emissions of volatile organic compounds (VOCs)
  • According to ISO 18562-4: Tests for leachables in condensate
  • In co-operation with an external consultant, Danish Technological Institute can facilitate the involvement of experienced consultants for standard analyses. The consultants can give advice and help prepare the correct analysis programme and carry out risk assessments.

The laboratory is accredited according to ISO/IEC 17025:2017

 

Examples of gas breathing pathways are: ventilators, anesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low pressure hose assemblies, humidifiers, heat and moisture exhangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breating system filters, Y-pieces, breathing accesories intended to be used with the equipment, the enclosed chamber of an incubator, including the mattress and the inner surface og an oxygen hood.