When this applies
When you want the chemistry and the conclusion together rather than as two purchases. ChemTox pairs an ISO 10993-18 extractables programme with the ISO 10993-17 assessment — the combination that lets chemical data address biological endpoints under ISO 10993-1:2025 instead of animal testing.
When to run it
Early, in place of commissioning chemistry and assessment separately. PLUS is the single-replicate configuration; MAX (GRK-3000) is the triplicate version. Choose PLUS where the programme is a first characterisation or a screening exercise, and MAX where the submission needs the more defensible extraction design or where a single-replicate programme has previously been challenged. That choice is worth making deliberately: upgrading afterwards means re-running the extraction.
What the result gives you
A full extractables profile across the solvent range with compound-family grouping applied, and every constituent above the toxicological threshold assessed against its tolerable exposure per ISO 10993-17 — chemistry and safety conclusion in one report, issued under Groenakker cover.
What it does not settle
It does not close out endpoints that are not chemically driven: implantation local effects and, depending on device category, parts of the hemocompatibility battery still require testing. ChemTox reduces the animal programme; it does not always eliminate it. And single replicate is the lighter design — where the extraction needs to be defensible against challenge, triplicate is the answer.
Method
Exhaustive extraction, single replicate, with solvent compatibility and compound-family grouping applied. Extraction ratio per 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. Chemistry per ISO 10993-18:2020; assessment of constituents above the toxicological threshold per ISO 10993-17:2023.
Where it runs
The analytical work is subcontracted to an ISO/IEC 17025 accredited, GLP certified laboratory; the toxicological assessment is performed by Groenakker and signed by a board-certified toxicologist.
Usually ordered alongside
A biological evaluation plan (GRK-1001), which establishes what the programme needs to cover, and cytotoxicity as the baseline biological screen.
