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. Non-volatiles are the fraction GC/MS cannot see — polymer additives, oligomers, surfactants and degradation products — and hexane is the non-polar solvent, representing the worst case for lipophilic compounds.
When to run it
With the other organic screens, on finished, sterilised material, once the material and process are locked. It is normally ordered as part of a three-solvent set with the SVOC and VOC screens so the extractables profile is complete across polarity and volatility.
What the result tells you
A list of non-volatile compounds identified in the n-hexane 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. Identification confidence is reported, because high-resolution MS identifies many non-volatiles tentatively rather than against a library.
What it does not tell you
Nothing about volatiles or semi-volatiles, which need GC-based methods, 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 n-hexane, and the extract is analysed by HPLC coupled to quadrupole time-of-flight mass spectrometry; compounds are identified from accurate mass and fragmentation 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.
