Biocompatibility - ISO 18562: Evaluation of breathing gas pathways

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Biocompatibility - ISO 18562: Evaluation of breathing gas pathways

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01. Medical devices02. ISO 18562: Evaluation of breathing gas pathways03. ISO 10993-7: Ethylene oxide sterilization residuals04. Combination products05. Pharmaceutical Packaging and Delivery Systems06. Stability of reagents for in vitro diagnostic (IVD)

EN ISO 18562: Medical devices - Newly revised 2024 edition has now been published

All four parts of the newly revised version of ISO 18562 for breathing gas pathways have now been published.

This means that breathing gas pathways used in healthcare applications must be evaluated according to this new edition of the standard: ISO 18562:2024: Biocompatibility evaluation of breathing gas pathways in healthcare applications.

 

Main changes

The main changes include:

  • Determination of the emission of very volatile organic compounds (VVOC) - e.g., volatile aldehydes - including formaldehyde and isocyanates if deemed relevant.
  • Lower reporting limit for the emission of the sum of all volatile organic compounds, now grouped under a new definition: VOS (Volatile Organic Substances).
  • Stricter requirements to when it is relevant to test for leachables in the condensate.
  • Potential users (patients) are classified into new groups to ensure that the established limits are in harmony with every individual.

Overall, the revision of the standard involves an expansion of the parameters being tested and imposes stricter requirements to when it is relevant to test for leachables.

 

Description of the tests

According to the standard, medical devices must be tested for emissions of particulate matter, volatile organic substances (VOS), and leachables (eluates) into the condensate. The latter is only necessary if relevant to the medical device.

Medical devices tested according to the previous edition may require an update with additional tests to comply with the new requirements.

Please feel free to contact us if you need more information.

 

How can Danish Technological Institute help you?

We offer testing of medical devices according to all parts of the standard:

  • ISO 18562-2:2024: Tests for emissions of particulate matter
  • ISO 18562-3:2024: Tests for emissions of volatile organic substances
  • ISO 18562-4:2024: Tests for leachables in condensate

 

The laboratory at Chemical Characterisation and Services is accredited according to ISO/IEC 17025:2017.

Danish Technological Institute collaborates with toxicologists who can perform risk assessments.

Medical devices include ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters, as well as any accessories intended to be used with such medical devices, the enclosed chamber of an incubator including the mattress, and inner surfaces of an oxygen hood.