When this applies
Whenever you have chemical characterisation data and need it to mean something. ISO 10993-17:2023 is the step that turns an extractables list into a safety conclusion, and under ISO 10993-1:2025 it is the mechanism by which several biological endpoints can be addressed without animal testing.
When to run it
Immediately after chemistry, and before commissioning any biological test the assessment might make unnecessary. Three weeks of assessment routinely removes tests from a programme.
What you receive
Each identified constituent assessed against its tolerable exposure, with a margin of safety reported per constituent, in a report signed by a DABT board-certified toxicologist. A conclusion you can put in a submission, not a data table.
What it does not settle
An assessment can only speak to constituents the chemistry actually identified. If the extraction did not cover the relevant solvent polarity or volatility range, the assessment inherits that gap — and a reviewer will find it. It also cannot substitute for endpoints that are not chemically driven, such as implantation local effects.
Method
Assessment per ISO 10993-17:2023. Identified constituents are evaluated against their tolerable exposure for the device’s clinical use, contact duration and patient population, and a margin of safety is derived for each. Turnaround 3 weeks.
Who performs it
This is performed by Groenakker, not subcontracted. The assessment is authored and signed by a DABT board-certified toxicologist and issued in Groenakker’s template — or in yours on request at no extra cost — under Groenakker’s ISO 13485:2016 certified quality system.
Usually ordered alongside
The chemical characterisation it interprets, and a biological evaluation plan that establishes what the assessment needs to cover. ChemTox bundles chemistry and assessment into a single programme.
