Will your gas pathway device be compliant with ISO 18562:2024 by FDA’s 2026 deadline?

Kevin Wells, Research Fellow, Extractables & Leachables Testing; Andrew Blakinger, Senior Manager, Chemistry, Extractables & Leachables Testing and Toxicology Services; Eurofins Medical Devices Services

As we head into the fall of 2025, it seems odd to discuss compliance with a 2024 standard; however, the grace period for compliance ends soon. We are now less than a year away (July 2026) from the FDA requiring all gas pathway medical devices to have testing completed according to the 2024 version of ISO 18562. ISO 18562-1 through ISO 18562-4 outline testing required to ensure patient safety for any medical device used to supply gas to a patient. Eurofins Medical Devices Services has the capabilities to perform the three analytical portions of the ISO 18562:2024 series as well as the corresponding risk assessment.

The previous version of ISO 18562 series was published in 2017. Let’s take a quick look at some of the testing changes from the 2017 version to the 2024 version.

ISO 18562-2:2024 Test for emissions of particulate matter:

Eurofins Medical Devices Services uses a calibrated particle counter to measure the number of particulates emitted from the device. Under the 2024 version, the minimum duration of sampling should be the maximum intended cumulative daily exposure. In most cases, this means a 24-hour sampling period is most appropriate, although a shorter duration may be justified in some cases for non-continuous use devices.

ISO 18562-3:2024 Test for emissions of volatile organic substances:

Part 3 of the standard was updated to require evaluation of a broader range of Volatile Organic Substances (VOS), including very volatile, volatile, and semi volatile organic compounds. Eurofins evaluates these three categories of VOS via a thermal desorption GC/MS method based on ISO 16000-6:2021. The 2024 standard also directs testing for aldehydes and carbonyls. Eurofins developed an LC/MS method to evaluate and target the aldehyde and carbonyl compounds from the gas pathway devices. Another update to the 2024 version is centered around the time course required for testing of prolonged and/or long-term use devices; the outcome is that VOS sample collection may now have to extend beyond 30 days.

ISO 18562-4:2024 Test for leachables in condensate:

Part 4 of the 2024 standard includes possible justification for not performing the leachables in condensate testing if the experimentally determined amount of condensate that reaches a patient under worst-case clinical conditions is no more than 0.1 mL in 24 hours. But in practice, it is often difficult to determine this condensate value experimentally. If testing is needed, the 2024 version of the standard requires GC/MS, LC/MS, and ICP/MS testing during the evaluation of leachables in condensate. In order to ensure this testing is conducted in alignment with FDA’s current expectations, Eurofins follows the guidelines outlined in FDA’s Draft Guidance “Chemical Analysis for Biocompatibility Assessment of Medical Devices,” published in Sept. 2024.

Final Thoughts

If you believe that your gas pathway device has not been evaluated to the 2024 version of ISO 18562 or was not in alignment with current regulatory expectations, we recommend contacting Eurofins Medical Device Services to ensure that your gas pathway device is fully compliant prior to the July 2026 deadline. Our skilled team of experts can conduct the required testing as well as the corresponding toxicological risk assessments to ensure a smooth regulatory approval process for your device.