When this test applies
For devices the patient breathes through, where volatile organics and inorganics are the concern and particulate matter is either not credible for the design or already addressed. ISO 18562 exists because inhaled exposure is not the ISO 10993 extractables problem: there is no liquid extraction, and dose depends on minute volume and breathing duration rather than on extraction ratio.
When to run it
On the finished device in its final configuration, since emissions come from the assembled flow path rather than the raw material. Run it before the submission and after any change to materials, adhesives or cleaning — those are the usual sources of a VOC finding. If particulate matter is credible for your flow path, order the combined analysis (GRK-5001-04) instead; adding it later means repeating the sampling.
What the result gives you
A GLP report identifying and quantifying the volatile organic and inorganic analytes recovered over a 48-hour sampling period, reported against the toxicological threshold applied in the accompanying risk assessment.
What it does not settle
It produces analyte quantities, not a safety conclusion — that is the gas pathway risk assessment (GRK-2003). It also does not cover particulate matter, which is a separate ISO 18562-2 endpoint, and a 48-hour sampling period does not characterise emissions over a longer clinical use.
Method
Testing per ISO 18562-3:2024 by 48-hour gas-pathway simulation. Identified analytes are quantified against the applied threshold. 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, and the combined particulate, VOC and inorganics analysis (GRK-5001-04) where particulate matter is also in scope.
