Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications

Medical devices, such as ventilators, CPAP machines, and nebulizers, use compressed gases, compressors, and fans for delivery of gases to patients. The FDA requires the air output of these devices, as well as other delivery aids like tracheostomy tubes, cannulas, and respiratory therapy devices, be evaluated for contaminants.

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The International Organization for Standardization (ISO) has published ISO Standard 18562:2017 – Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – which address the risk of potentially hazardous contaminants delivered to patients through the gas pathways. The standard includes:

  • Part 1 – Evaluation and testing within a risk management process
  • Part 2 – Tests for emissions of particulate matter
  • Part 3 – Tests for emissions of volatile organics compounds (VOCs)
  • Part 4 – Tests for leachables in condensate

LEGEND offers custom air output capture systems for medical devices allowing real-time monitoring and sample collection/analysis for specific contaminants following Parts 2 and 3 of ISO 18562:2017. Additionally, LEGEND offers testing for leachables in condensate pursuant to Part 4.

LEGEND provides a variety of real-time monitoring instrumentation and laboratory analytical methods to meet the requirements of ISO 18562, including:

  • Volatile Organics Compounds (EPA TO-15)
  • PM2.5/PM10 Particulates (Real Time Monitoring)
  • Leachables in Condensate
  • Ozone, Carbon Monoxide, Carbon Dioxide
  • ISO 16000-3 – Determination of formaldehyde and other carbonyl compounds in indoor air and test chamber air – Active sampling method

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