ISO 18562 establishes a four-part framework for assessing the biocompatibility of breathing gas pathways in medical devices. It sets clear guidelines for evaluating device safety, including recommendations for clinically relevant flow rates. Devices must be assessed under both ISO 18562 and ISO 10993 frameworks. However, understanding the testing requirements, planning your submission, and managing complex test protocols - all while meeting critical go-to-market deadlines - can place a strain on even the most experienced teams. 

The Eurofins Medical Device Services network of laboratories mitigates this pressure with proven expertise in ISO 18562 testing for breathing gas pathways. As early contributors to the standard's development in 2017, our scientists have been involved since its inception and continue to refine platform methods to meet all aspects of this four-part framework. Whether you’re unsure when to begin testing, need to define how many samples are required, or lack in-house regulatory knowledge, we can support you in ensuring your device complies fully with ISO 18562 and ISO 10993 requirements to ensure a complete regulatory submission. 

ISO 18562 defines three key hazards related to the gas pathways of medical devices: emissions of particulate matter (PM2.5 and PM10), the release of Volatile Organic Compounds (VOCs) into the gas stream, and the presence of leachables in condensate from devices that deliver humidified gases. To collect leachable substances, the standard outlines three methods: Forming condensation under simulated clinical use, circulating water through the pathway under clinical-like conditions, or conducting aqueous extraction in accordance with ISO 10993.

Our comprehensive testing:

• ISO 18562-1: Evaluation and testing within a risk management process
• ISO 18562-2: Emissions of particulate matter (PM2.5 and PM10)
• ISO 18562-3: Volatile Organic Compounds (VOCs) emitted in gas streams
• ISO 18562-4: Leachables in condensate for humidified gas delivery
• Interpret inhalation toxicity data relevant to breathing gas pathways for your device per ISO 10993-17.
• ISO 10993-5 and ISO 10993-10: Additional testing, as required
• ISO 10993-17: Interpret inhalation toxicity data relevant to breathing gas pathways for your device
• Toxicological Risk Assessments

To generate data, we apply:

• Particle counters to measure particulate matter emitted from your device
• Gas Chromatography Mass Spectrometry (GC/MS) for VOCs analysis
• GC/MS, Liquid Chromatography Mass Spectrometry (LC/MS), and Inductively Coupled Plasma (ICP) for leachables in condensate analysis
• Toxicological Risk Assessments

Our instrumentation:

• Agilent Time-of-Flight (TOF) or Quadrupole Time-of-Flight (QTOF) with LC 
• Agilent MS with GC and PerkinElmer TurboMatrix 350 ATD 
• Agilent 7900 ICP/MS 
• PerkinElmer Optima 5300 Inductively Coupled Plasma (ICP-OES) Spectrophotometer 
• TSI DustTrak™ Aerosol Monitor 8533
• Proprietary Manifold for Assessing the Biocompatibility of Gas Pathways