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. Semi-volatiles are the fraction GC/MS resolves best, and water is the polar solvent, simulating aqueous body fluids and the compounds that migrate into them.
When to run it
With the other organic screens, on finished, sterilised material, once the material and process are locked. ISO 10993-18 expects the solvents to bracket the polarity of the clinical contact, so this screen is normally ordered as part of a three-solvent set rather than alone.
What the result tells you
A list of semi-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 volatiles (headspace GC/MS) or non-volatiles (HPLC/MS), and nothing about what the other solvents 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, followed by threefold liquid-liquid extraction with dichloromethane, and the extract is analysed by 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.
