When this applies
When an extractables profile turns up a constituent that has no established tolerable intake to compare against, and the margin of safety cannot be calculated without one. ISO 10993-17:2023 sets out how TI and EEDmax are derived; this is that derivation, done properly and documented, for one constituent at a time.
When to run it
During the main risk assessment, as it becomes clear which constituents need it. Most do not — published tolerable intakes cover the common ones — so this is a per-constituent add-on rather than a routine line item.
What you receive
A derived tolerable intake and maximum estimated exposure dose for the constituent, with the toxicological data used, the uncertainty factors applied and the reasoning documented so the derivation can be audited rather than taken on trust.
What it does not settle
A derivation for one constituent is not a risk assessment. The margin of safety, the treatment of mixtures and the overall conclusion belong in the ISO 10993-17 assessment (GRK-2001) that this feeds. Where the toxicological data for a constituent is genuinely absent, the honest output is a stated uncertainty rather than a manufactured number.
Method
Derivation per ISO 10993-17:2023 from the available toxicological data for the constituent, for the device’s clinical use, contact duration and patient population.
Who performs it
This is performed by Groenakker, not subcontracted. The assessment is authored and signed by a 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 ISO 10993-17 risk assessment (GRK-2001) it supports, and the chemical characterisation that identified the constituent.
