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. Elemental analysis is the inorganic half of that profile: metals and metalloids are not seen by the organic screens, and several — lead, cadmium, nickel, cobalt, chromium — carry low tolerable intakes under ISO 10993-17 and ICH Q3D.
When to run it
Early in the chemistry programme, on finished, sterilised material. It is quick and relatively inexpensive, and a metal above its reporting limit usually points at a pigment, catalyst residue, filler or alloy that you want to know about before the organic screens are interpreted.
What the result tells you
A concentration, or a value below the reporting limit, for each of the 34 elements. Elements are quantified against their reporting limits rather than an analytical evaluation threshold, which applies to organic extractables; each concentration is then carried into the ISO 10993-17 risk assessment and compared with tolerable intake.
What it does not tell you
Nothing about organic extractables — VOC, SVOC and NVOC are separate screens. It reports total content, not speciation, so a high reading identifies an element to evaluate rather than a toxic form. 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 digested in concentrated nitric acid by microwave, and the digest is analysed by ICP-MS and ICP-OES for 34 elements. 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.
