When this test applies
Required for implanted devices and for devices contacting breached or compromised tissue, under ISO 10993-1:2025. The route and the duration are chosen to represent the clinical use: the intramuscular or subcutaneous route for soft-tissue contact, bone for osseous contact.
When to run it
Late, and only once the material and its manufacturing process are locked. Implantation is the longest and most expensive study in the battery, and the 2-week timepoint answers a different question from the 13- and 26-week ones — the short study characterises the acute local response, the long ones characterise resolution and chronic response.
What a pass tells you
That the histological response at the test sites, scored against the control sites per ISO 10993-6 Annex E, produced an irritation ranking of 2.9 or less — classed as a non-irritant over this implantation period by this route.
What it does not tell you
Nothing about the response at a longer timepoint, by a different route, or in bone. It also says nothing about systemic effects, genotoxicity or sensitization. A 2-week non-irritant result does not predict the 13- or 26-week outcome, which is precisely why the longer studies exist.
Method
Testing per ISO 10993-6:2016. Solid samples are implanted directly — there is no extraction step — with sample geometry prepared to the dimensions ISO 10993-6 specifies for the intramuscular or subcutaneous route. Test and control sites are recovered at the 2-week timepoint, processed histologically, and scored to derive an irritation ranking per Annex E.
Where it runs
This method is internationally sourced. The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker’s ISO 13485:2016 certified quality system, in your document format.
Usually ordered alongside
Cytotoxicity, sensitization and irritation as the baseline, and often a longer implantation timepoint in the same programme. Your biological evaluation plan should establish which timepoints the device category actually requires before any of them are commissioned.
