When this applies
When a biological evaluation needs to justify an endpoint from existing knowledge rather than from new testing, and the material in question was not covered by the original search. Under ISO 10993-1:2025 published data is a legitimate evidence route — but only when the search behind it is documented and reproducible, which is what distinguishes this from a web search.
When to run it
Before commissioning a test you may be able to justify away. At one day’s turnaround it is the cheapest line on this catalog relative to what it can remove from a programme.
What you receive
A documented, structured search of the published toxicological literature for the material, with the search strategy recorded so a reviewer can see what was covered and what was not — written to slot into the endpoint justification in your plan or report.
What it does not do
A literature search is not a conclusion. Whether the published data is adequate to justify the endpoint is a judgment made in the biological evaluation, and where the literature is thin the honest outcome is that testing is still required. It also covers one material: a multi-material device needs one search per material.
Method
A structured search of the published toxicological literature for the named material, with strategy and results documented per ISO 10993-1:2025.
Who performs it
This is performed by Groenakker, not subcontracted. The document is 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 Biological Evaluation Plan or Report it supports, and an ISO 10993-17 risk assessment where the literature needs to be turned into a quantitative safety conclusion.
