When this applies
For any device with a gas pathway the patient breathes through — ventilator circuits, anaesthesia components, humidifiers, oxygen delivery. ISO 18562 replaced the practice of assessing these under the ISO 10993 extractables model, because inhaled exposure is a different route with different arithmetic: dose depends on minute volume and breathing duration, not on extraction ratio.
When to run it
Straight after the gas pathway analysis, and before the submission. The analysis on its own is a table of analytes; this is the document that concludes on patient safety, and it is the one a reviewer reads.
What you receive
Each gas-pathway analyte assessed against its tolerable exposure for the intended breathing duration, per ISO 18562-1 and ISO 10993-17:2023, with the reasoning and any residual uncertainty stated. Three weeks.
What it does not settle
An assessment can only speak to analytes the analysis actually recovered. If the gas pathway testing did not cover the relevant compound classes or a long enough sampling period, the assessment inherits that gap — and it will say so rather than conclude past it. It also does not address particulate matter unless particulate analysis was performed.
Method
Assessment per ISO 18562-1:2024 and ISO 10993-17:2023. Analytes from the gas pathway analysis are evaluated against tolerable exposure for the device’s intended breathing duration and patient population.
Who performs it
This is performed by Groenakker, not subcontracted. The assessment is authored and signed by a board-certified toxicologist and issued in Groenakker’s template — or in yours on request at no extra cost — under Groenakker’s ISO 13485:2016 certified quality system.
Usually ordered alongside
The gas pathway analyses it interprets — VOC and inorganics (GRK-5001-03) and the 48-hour particulate, VOC and inorganics analysis (GRK-5001-04).
