When this test applies
ISO 10993-1:2025 makes chemical characterisation the starting point of a biological evaluation for prolonged and long-term contact devices, and the route by which an ISO 10993-17 assessment can address the systemic, subacute, genotoxicity and carcinogenicity endpoints without animal studies. ChemTox MAX is the full-replicate version: triplicate extraction gives the statistical basis a reviewer expects for a permanent implant, a high-risk device or a submission where the chemistry carries the weight of the evaluation.
When to run it
Before the animal studies, with the material and process locked and on finished, sterilised devices. Done first, the assessment routinely removes systemic toxicity, repeated-dose and genotoxicity studies from a programme; done last, it only confirms what the animals already said. Allow 14 to 16 weeks from receipt of samples.
What a pass tells you
A compound-by-compound conclusion: every constituent above the toxicological screening limit evaluated with a derived tolerable intake and a margin of safety, screened against REACH, ECHA SVHC, Annex XVII and FDA lists, and a clear statement of whether the device's extractables profile supports its intended use — with the residual uncertainty stated, not hidden.
What it does not tell you
Nothing that chemistry cannot reach: sensitization, irritation, local implantation effects and hemocompatibility remain biological endpoints with their own tests. It also does not characterise what the three solvents do not extract or what the techniques cannot detect, and a process change after testing changes the profile.
Method
ChemTox MAX bundles exhaustive chemical characterisation per ISO 10993-18:2020 with a toxicological risk assessment per ISO 10993-17:2023 in one package. Three solvents are selected and justified against the intended clinical use, extraction is exhaustive and run in triplicate, and every extract is screened for non-volatile residue, heavy metals (34 elements by ICP-MS/ICP-OES), VOC (headspace GC/MS), SVOC (GC/MS) and NVOC (HPLC/Q-ToF/MS), with methods validated to sensitivity at or below the analytical evaluation threshold. Every constituent above the toxicological screening limit then receives a tolerable intake and margin of safety, with the EU MDR CMR and endocrine-disruptor review included, reviewed and approved by an in-house PhD chemist and a DABT board-certified toxicologist. Sample size: 1,278 cm² and a minimum of 33 testable units. 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
Chemistry at ISO/IEC 17025 accredited laboratories in Groenakker’s network to Groenakker protocols; the toxicological risk assessment in-house at Groenakker, signed by a DABT board-certified toxicologist, under Groenakker’s ISO 13485:2016 certified quality system. The final report is issued in Groenakker’s template or in your document template on request at no extra cost.
Usually ordered alongside
A biological evaluation plan to set the endpoints the assessment must address, the detailed chemical evaluation protocol and report (GRK-2005) where the chemistry will be submitted to the FDA, and the biological tests chemistry cannot replace — cytotoxicity, sensitization and irritation.
