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Medical devices - Breathing gas pathways

Helle Stendahl Andersen

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Farmaceutiske produkter og medicinske utensilier

Medical devices - 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.

The new standard was published in 2017 and applies to new medical devices as well as existing breathing gas pathways of medical devices that already are on the market. The deadline for the latter is the end of 2020.

The requirements apply to all breathing gas pathways of medical devices irrespective of wherever they are sold.


How can Danish Technological Institute help you?

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. Both parties are already experienced in the preparation of analyses and subsequent documentation according to ISO 18562.

In co-operation with an external consultant Danish Technological Institute can offer:

  • Advice on choice of analysis programme
  • Implementation of analyses according to ISO 18562
  • Interpretation of results from tests performed
  • Preparation of documentation for the Authorities