When this test applies
ISO 18562-1:2024 applies to any device whose gas pathway delivers breathing gas to a patient — ventilators, anaesthesia systems, breathing circuits, masks, humidifiers, CPAP and nebuliser tubing — and replaces the ISO 10993 extraction model, which does not represent inhalation. ISO 18562-2 covers particulate matter and ISO 18562-3 covers VOC emissions; this study runs both.
When to run it
On the finished, sterilised or cleaned device in its final configuration, once materials and process are locked, and before the gas pathway toxicological risk assessment (GRK-2003) that reads the results. The 48-hour duration is set by the standard for devices used beyond 24 hours; confirm the exposure duration and flow conditions against your device's intended use before commissioning.
What a pass tells you
A quantified emission rate for each particle size fraction, volatile organic compound and inorganic analyte detected over the 48-hour period, reported against the toxicological threshold applied in the accompanying risk assessment. The result is a dataset for the toxicologist, not a pass/fail in itself.
What it does not tell you
Nothing about leachables into condensate or liquid contact — ISO 18562-4 covers that separately — and nothing about the standard ISO 10993 endpoints for parts of the device that contact the patient directly. It also tests the device as supplied: a change of material, cleaning agent or sterilisation changes the emissions.
Method
Testing per ISO 18562-2:2024 and ISO 18562-3:2024. Clean breathing gas is passed through the device under controlled flow, temperature and humidity for 48 hours and the effluent is sampled for particulate matter by filtration and particle counting, and for VOCs by sorbent tube with thermal desorption GC/MS and for selected inorganic gases by specific detectors. Three samples are required — one for VOC, one for set-up and one retain. No ISO 10993-12 liquid extraction is involved. The price includes preparation and decontamination for sample return; shipping is billed separately.
Where it runs
Testing is performed to Groenakker protocols at an ISO/IEC 17025 accredited, GLP certified laboratory in Groenakker’s network, and the report is issued under Groenakker’s ISO 13485:2016 certified quality system, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
The gas pathway toxicological risk assessment (GRK-2003) that converts emission rates into inhaled dose and margin of safety, the VOC-only study (GRK-5001-03) where particulate is already covered, and the ISO 10993 battery for the patient-contacting parts of the device.
