ISO 18562 – Breathing Gas Pathway Biocompatibility

What is ISO 18562?

ISO 18562 is a series of international standards that specifically address the biocompatibility evaluation of breathing gas pathways in healthcare applications — essentially, it governs the safety testing of medical devices that carry gases to and from a patient's respiratory system.

General biocompatibility standards like ISO 10993 weren't originally designed with gas-pathway-specific risks in mind (like inhaled particulates or vapor-phase chemicals). ISO 18562 fills that gap, focusing specifically on risks relevant to breathing circuits.

Close-up of a breathing gas pathway mask and tubing evaluated under ISO 18562

Why it matters

What a patient breathes matters as much as what they receive intravenously.

✦ Part 1 establishes the overall risk management framework, determining which of the subsequent parts apply to devices such as ventilators and anesthesia machines.
✦ Part 2 evaluates particulate matter released into the breathing gas pathway, protecting patient respiratory safety.
✦ Part 3 identifies and quantifies volatile organic compounds (VOCs) emitted from pathway materials and their toxicological impact via inhalation.
✦ Part 4 addresses leachable substances in condensate from humidified breathing circuits and the patient exposure risk they carry.

What's included

Methodologies we apply

Part 1: Risk Management Framework

Establishing the overall framework and determining which parts apply to your device.

Part 2: Particulate Matter Emissions

Testing methods to evaluate particulate matter released into the breathing gas pathway.

Part 3: VOC Emissions

Identifying and quantifying volatile organic compounds and their inhalation toxicology.

Part 4: Leachables in Condensate

Evaluating leachable substances in condensate from humidified breathing circuits.

How we evaluate it

Our process for your ISO 18562 evaluation

1

Determine Applicable Parts

We assess your device's breathing gas pathway to determine which of Parts 2–4 apply.

2

Test Particulate & VOC Emissions

Pathway materials are tested for particulate matter and volatile organic compound emissions.

3

Evaluate Condensate Leachables

For humidified circuits, leachables in condensate are identified and assessed.

4

Compile Risk-Based Conclusion

Findings are compiled into a risk management conclusion aligned to Part 1.

The deliverable

What you receive

A determination of which ISO 18562 parts apply to your device.

Documented particulate matter and VOC emissions testing results.

A condensate leachables evaluation for humidified breathing circuits.

A risk-based conclusion ready for your technical documentation.