When this applies
ISO 10993-1:2025 expects every patient-contacting material to be identified and its biological risks evaluated, and a documented literature search is what supports addressing an endpoint without testing. The base plan covers five materials; devices with more — multi-component kits, coated or multi-layer constructions, assemblies with adhesives and inks — need each additional material worked through.
When to commission it
At the time the plan is commissioned, once the bill of materials is complete. Allow one day per material from receipt of the material identity and supplier documentation.
What you receive
For the material: a documented search of the published toxicological and biocompatibility literature, an evaluation of the risks it presents for each relevant biological endpoint, and the conclusion — whether the endpoint can be addressed by literature, needs testing or needs chemistry — written into the plan.
What it does not cover
Testing of the material, which is quoted separately, and additional contact categories, which are GRK-1003. A literature search cannot address an endpoint where the published data are absent; in that case it says so and the plan routes the endpoint to testing.
Method
Adds one patient-contacting material to the biological evaluation, with a documented literature search and an evaluation of its risks for each relevant endpoint. Groenakker’s biological safety specialists identify the material by composition and supplier, search the published literature and recognised databases, assess the findings against the ISO 10993-1:2025 endpoints applicable to the contact category, and document the search and conclusion in the plan.
Who does the work
In-house at Groenakker. The work is authored, reviewed and approved by Groenakker’s biological safety specialists under its ISO 13485:2016 certified quality system, and issued in Groenakker’s template or in your document template on request at no extra cost.
Usually ordered alongside
The Biological Evaluation Plan (GRK-1001) it extends, the additional contact category (GRK-1003) where a new material also brings a new contact type, and toxicological risk assessment without E&L data (GRK-2006) where composition and SDS data have to carry the evaluation.
