When this test applies
Chemical characterisation is the backbone of the modern route through ISO 10993-1:2025 — it is how endpoints get addressed with data instead of animals. Total elemental content is the metals arm of that profile, and it applies wherever the material, its pigments, catalysts, fillers or processing aids could contribute elemental impurities.
When to run it
Early, and before you commission biological testing you may not need. Chemistry paired with an ISO 10993-17 assessment can close out several endpoints outright, so running it first tends to shrink the programme. Running it after the animal studies inverts both the logic and the cost.
What the result gives you
A GLP report quantifying each of the 34 elements against its reporting limit, with the extraction conditions documented — issued in Groenakker’s template — or in yours on request at no extra cost — under Groenakker’s ISO 13485:2016 certified quality system. If your own toxicologist writes the assessment, this is the dataset they need and the documentation trail a reviewer will ask for. If you would rather we reached the conclusion, the ISO 10993-17 assessment is the next line item.
What it does not settle
Chemical characterisation has no independent pass or fail. Elements 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. This analysis also covers elements only — volatile, semi-volatile and non-volatile organics and non-volatile residue are separate arms across separate solvents. A profile that covers one arm and not the polarity and volatility range is the most common gap a reviewer finds.
Method
Testing per ISO 10993-18:2020/Amd 1:2022. One extract is prepared at 10 mL, using the ISO 10993-12 extraction ratios: 6 cm2/mL for material under 0.5 mm thick, 3 cm2/mL at 0.5 mm or thicker, or 0.1–0.2 g/mL where surface area is indeterminate. The extract is analysed by ICP-MS and ICP-OES for 34 elements, each quantified against its reporting limit. Turnaround 4–5 weeks.
Where it runs
The analytical work is subcontracted to an ISO/IEC 17025 accredited, GLP certified laboratory. The report is issued under Groenakker’s ISO 13485:2016 certified quality system, in your document format.
Usually ordered alongside
The organic screens across the solvent range — VOC, SVOC, NVOC and non-volatile residue in water, isopropyl alcohol and n-hexane — and an ISO 10993-17 toxicological risk assessment to interpret the whole profile. ChemTox bundles the chemistry and the assessment as one programme; if you are not sure how much of the range your device needs, start with a biological evaluation plan.
