When this applies
Many devices fall into more than one contact category — a catheter with a skin-contacting hub and a blood-contacting lumen, a kit with components of different durations. ISO 10993-1:2025 requires each category to be assessed for its own endpoint set, and the BEP and BER base prices cover one category. This item adds the next.
When to commission it
At the time the plan or report is commissioned, once the device's contact categories are known. Identifying a second category after testing is under way usually means a second round of extracts, so settle it early. Allow one week.
What you receive
The additional category worked through in the same document: contact categorisation, the ISO 10993-1:2025 Annex A endpoint set for that category, a risk evaluation and the testing or justification strategy for each endpoint, integrated with the primary category so that shared tests are not duplicated.
What it does not cover
Additional materials beyond the five included in the base plan, which are the additional material literature search (GRK-1004), and any testing the added category calls for, which is quoted separately. It extends an existing plan or report rather than standing alone.
Method
Extends a biological evaluation plan or report to one additional patient-contacting category, with its own endpoint set and strategy under ISO 10993-1:2025. Groenakker’s biological safety specialists categorise the additional contact under ISO 10993-1:2025, map its endpoints, assess the materials and existing evidence against them, and write the strategy into the plan or report. Priced per distinct patient-contacting category.
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) or Report (GRK-1002) it extends, and the additional material literature search (GRK-1004) where the second category also introduces new materials.
