August 29, 2025
UL Solutions would like to inform the respiratory medical device industry of a critical regulatory deadline that directly impacts medical devices with breathing gas pathways.
The U.S. Food and Drug Administration (FDA) has officially recognized the ISO 18562:2024 series, replacing the 2017 version.
ISO 18562 is a series of standards focused on the biocompatibility evaluation of breathing gas pathways in medical devices. This change introduces new testing requirements and a firm compliance deadline that all manufacturers must meet to maintain market access.
UL Solutions strongly urges all manufacturers to begin the transition ahead of the deadline to avoid delays in regulatory approvals and maintain uninterrupted product availability.
FDA compliance deadline: July 5, 2026
After this date, the FDA will no longer accept declarations of conformity to the 2017 versions of ISO 18562.
All premarket submissions must comply with the 2024 revision, which includes:
- ISO 18562-1:2024 – Risk management and evaluation framework
- ISO 18562-2:2024 – Particulate matter testing
- ISO 18562-3:2024 – Volatile Organic Substance (VOS) emissions testing
- ISO 18562-4:2024 – Leachables in condensate testing
Key changes in ISO 18562:2024
Compared to the 2017 version, the 2024 version introduces updates reflecting the industry’s growing emphasis on patient safety and long-term device performance, including:
- Stricter emission thresholds for VOSs and particulates
- Expanded scope to include respiratory personal protective equipment (PPE) such as surgical masks and N95 respirators
- Enhanced alignment with ISO 10993 for biocompatibility and risk management
- Lifecycle monitoring requirements, including post-market surveillance
- Material-specific testing based on device composition and manufacturing processes
The ISO 18562 series of standards outlines general principles for the evaluation of breathing gas pathways of medical devices used in respiratory care or to supply anesthesia or other substances through the respiratory tract.
Testing and evaluation according to the ISO 18562 series of standards is conducted for new device introductions and may include testing devices at various stages of their service life to evaluate material changes.
Testing of devices that are already used in the market may also be required to evaluate changes to materials suppliers or manufacturing processes that may affect emissions into the breathing gas pathway.
Our global teams of air quality specialists work closely with manufacturers to identify required testing and compliance needs early in the process. As part of our comprehensive evaluation, UL Solutions also conducts toxicological risk assessments based on ISO 18562 test data to determine potential exposure risks during typical device use.
Our toxicologists bring specialized expertise in assessing inhalation exposure risks, particularly those unique to respiratory devices.
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