When this test applies
For any device the patient breathes through — ventilator circuits, anaesthesia components, humidifiers, oxygen delivery. ISO 18562 exists because inhaled exposure is not the ISO 10993 extractables problem: there is no liquid extraction, the dose depends on minute volume and breathing duration, and particulate matter carried in the gas stream is an endpoint in its own right. This is the two-part version, covering both particulates and the volatile and inorganic analytes.
When to run it
On the finished device in its final configuration, since gas-pathway emissions come from the assembled flow path rather than from the raw material. Run it before the submission and immediately after any change to materials, adhesives or the cleaning process — adhesives and residual cleaning agents are the usual sources of a VOC finding.
What the result gives you
A GLP report quantifying particulate matter and the identified volatile and inorganic analytes over a 48-hour sampling period, reported against the toxicological threshold applied in the accompanying risk assessment. That report plus the assessment is what a reviewer expects to see for a breathing-gas pathway.
What it does not settle
The analysis produces analyte quantities, not a safety conclusion — the judgment about patient safety is made in the gas pathway risk assessment (GRK-2003), which weighs each analyte against tolerable exposure for the intended breathing duration. A 48-hour sampling period also does not characterise emissions over a longer clinical use; where the device is used for weeks, that gap needs addressing explicitly.
Method
Testing per ISO 18562-2:2024 for particulate matter and ISO 18562-3:2024 for volatile organic compounds, by 48-hour gas-pathway simulation. There is no ISO 10993-12 liquid extraction — the gas stream itself is sampled.
Where it runs
This analysis is subcontracted to an ISO/IEC 17025 accredited, GLP certified laboratory, and the report is issued under Groenakker cover, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
The gas pathway risk assessment (GRK-2003) that interprets it — the analysis is data without a conclusion on its own. Where particulates are not in scope, the VOC and inorganics analysis alone (GRK-5001-03) is the shorter version.
