Irritation
ISO 10993-23 irritation testing asks whether an extract produces local tissue reactivity. Intracutaneous reactivity and route-specific studies are listed as separate methods, with extracts and sample mass on the method page.
Irritation is rarely ordered aloneIrritation sits in the ISO 10993-1:2025 baseline alongside cytotoxicity and sensitization, and the three share the same extracts. Running them together avoids a second extraction and a second sample shipment.
Irritation: Intracutaneous Reactivity (ISO), 2 Extracts (GLP)
Irritation asks whether an extract of your device provokes a local inflammatory response in living tissue.
GRP-4003-INTRA
Irritation: Vaginal Irritation with Histology (ISO), 2 Extracts (GLP) - Domestically Sourced
Vaginal irritation asks what the mucosal tissue does in response to your device’s extractables.
GRK-4003-02D
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