When this test applies
Chemical characterisation is how endpoints get addressed with data rather than with animals under ISO 10993-1:2025. This particular arm is one cell of a grid — volatility on one axis, solvent polarity on the other. It targets residual monomers, residual process solvents, sterilant residues such as ethylene oxide and its chlorohydrin, and other low boilers, and in water specifically it is salts, acids, residual monomers carrying polar functionality, water-soluble process aids such as surfactants and polyethylene glycols, and hydrolysis degradants that come out. Water is the polar extreme and the closest analogue to the aqueous physiological environment, so a finding here is the one most directly relevant to a patient-contacting surface.
When to run it
Early, and commissioned as a solvent set rather than one arm at a time — the same extraction campaign supports all of them, and a partial profile usually has to be repeated. Before any of it, get the protocol and the analytical evaluation threshold agreed (GRK-2005): an AET set too high means the study missed things it should have found, and that is a finding a reviewer makes, not you.
What the result gives you
A GLP report giving a list of the volatile species the headspace released, each identified by library match and semi-quantified against its reporting limit, with the extraction conditions documented. If your own toxicologist writes the assessment, this is the dataset they need and the documentation trail a reviewer asks for. If you would rather we reached the conclusion, the ISO 10993-17 assessment (GRK-2001) is the next line item.
What it does not settle
Headspace only sees what will leave the matrix into the gas phase at the incubation temperature. Anything semi-volatile or heavier is invisible to it by design. Water barely touches the lipophilic end of the profile. Slip agents, hydrocarbon oils and phthalate-type plasticisers can be present in quantity and still not appear here, which is why the hexane arm exists. And chemical characterisation has no independent pass or fail at all: compounds are reported against analytical reporting limits, not against a safety threshold, so the judgment about patient safety is made in the ISO 10993-17 assessment rather than here.
Method
Testing per ISO 10993-18:2020/Amd 1:2022. A single extract is prepared in water at 10 mL, with the extraction ratio per ISO 10993-12: 6 cm²/mL for material under 0.5 mm thick, 3 cm²/mL at 0.5 mm or thicker, or 0.1 to 0.2 g/mL where surface area is indeterminate. The extract is analysed by headspace GC/MS.
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. Turnaround is 4 to 5 weeks.
Usually ordered alongside
The semi-volatile and non-volatile arms, since headspace covers only the low boilers. Where ethylene oxide sterilisation is used, EO and ECH residuals under ISO 10993-7 are a separate compendial test rather than part of this screen. And — critically — an ISO 10993-17 toxicological risk assessment to interpret the numbers. Chemistry without the assessment is data without a conclusion; ChemTox bundles the two.
