When this test applies
ISO 10993-1:2025 makes chemical characterisation to ISO 10993-18 the starting point of a biological evaluation for prolonged and long-term contact devices, and the preferred route to the systemic, genotoxicity and carcinogenicity endpoints wherever good extractables data can replace an animal study. Volatiles are a distinct fraction: headspace sampling is the technique that sees them, and residual solvents, monomers and low-molecular-weight additives are the compounds most likely to appear here.
When to run it
With the other organic screens, on finished, sterilised material, once the material and process are locked. A process change — a new cleaning solvent, a different sterilisation cycle — changes the volatile profile more than any other fraction.
What the result tells you
A list of volatile compounds identified in the water migrate, each semi-quantified against a justified analytical evaluation threshold (AET). Compounds above the AET are reported for toxicological evaluation; a compound above the AET is assessed, not automatically a failure.
What it does not tell you
Nothing about semi-volatile or non-volatile compounds, and nothing about what a non-aqueous solvent would extract. Chemical characterisation has no independent pass or fail: the data mean nothing until a toxicologist reads them against exposure under ISO 10993-17, and the screen cannot see compounds the solvent did not extract or the technique cannot detect.
Method
Testing per ISO 10993-18:2020/Amd 1:2022. The sample is extracted in water and the migrate is analysed by headspace GC/MS; compounds are identified against spectral libraries and semi-quantified against an internal standard. Extraction ratio follows 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.
Where it runs
Testing is performed to Groenakker protocols at an ISO/IEC 17025 accredited 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 other screens that make up a complete extractables profile — VOC, SVOC, NVOC and heavy metals across the three solvents — then the toxicological risk assessment (GRK-2001) that turns the compound list into a conclusion. The ChemTox packages bundle all of this for one price.
