When this applies
When you want the chemistry and the conclusion as one deliverable. ChemTox pairs an ISO 10993-18 extractables programme with the ISO 10993-17 assessment that interprets it — the combination that lets chemical data address biological endpoints.
When to run it
Early, in place of commissioning chemistry and assessment separately. MAX is the exhaustive, triplicate configuration; PLUS is the single-replicate equivalent. Choose MAX where the submission needs the more defensible extraction design, or where a prior single-replicate programme has been challenged.
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, signed by a DABT board-certified toxicologist.
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.
Method
Exhaustive extraction in triplicate, with solvent compatibility and compound-family grouping applied, using the ISO 10993-12 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. 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 DABT board-certified toxicologist, under our ISO 13485:2016 certified quality system.
Usually ordered alongside
A biological evaluation plan, which establishes what the programme needs to cover, and cytotoxicity as the baseline biological screen.
