When this test applies
ISO 10993-1:2025 flags irritation for every patient-contacting device, and ISO 10993-23:2021 directs that the model should reflect the actual contact site. For devices contacting vaginal mucosa — pessaries, intravaginal rings, applicators, speculums and similar — this is the site-specific irritation study, used in place of or in addition to intracutaneous reactivity.
When to run it
After cytotoxicity, with the material and process locked. Confirm with a biological evaluation plan that the vaginal route is the right model for your contact site; intracutaneous reactivity remains the default where no specific mucosal model is indicated, and running the wrong model is a study you repeat.
What a pass tells you
That macroscopic and histological scores for the test sites, compared with the control sites, did not exceed the non-irritant threshold in ISO 10993-23 for either extract — no erythema, oedema, epithelial damage, leukocyte infiltration or vascular congestion attributable to the device beyond control.
What it does not tell you
Nothing about sensitization, which is a delayed immune response assessed by a separate test, nor about cytotoxicity, systemic toxicity or genotoxicity. It also addresses the vaginal site only — a device that also contacts skin or another mucosa may need the corresponding model.
Method
Testing per ISO 10993-23:2021. Two extracts are prepared — polar (saline) and non-polar (sesame or cottonseed oil) — and applied intravaginally in the rabbit over the dosing period, with the corresponding blank as control. Sites are scored macroscopically, and the tissue is processed for histology and scored by a pathologist. Extraction ratio follows ISO 10993-12: 6 cm²/mL for material under 0.5 mm thick, 3 cm²/mL at 0.5 mm or thicker, or 0.1 to 0.2 g/mL where surface area is indeterminate.
Where it runs
This method is domestically sourced (US). 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 Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
Cytotoxicity as the baseline screen and sensitization to complete the surface-contact battery. Intracutaneous reactivity where the device also has contact outside the vaginal mucosa. If you do not yet have a biological evaluation plan, that is the place to start — a BEP typically removes tests from a list rather than adding them.
