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Irritation Testing

Irritation Testing

The Biocompatibility Irritation test determines if a material or device with which a patient would have contact is an irritant. It measures the reaction to a single, repeated or continual exposure from device materials that may produce skin, mucosal or ocular irritation. Irritation is a local tissue response characterized by the usual signs of inflammation, redness and swelling, and could be accompanied by heat and pain. This test complies with ISO 10993-10 and ISO 10993-12 standards.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA "Use of international standard ISO 10993-1"]

Applicable Standards

  • ISO 10993

Test Options

Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test Request Quote
SCX210 Irritation: Intracutaneous Reactivity (USP), 2 extracts Add
SCX220 Irritation: Intracutaneous Toxicity (ISO), 2 extracts Add
SCX230 Irritation: Primary Eye, 2 extracts Add
SCX240 Irritation: Primary Skin, each Add
SCX250 Irritation: Bladder, each Add
SCX260 Irritation: Vaginal, Direct exposure method for liquids Add
SCX265 Irritation: Vaginal, Device method, 2 extracts Add
SCX270 Irritation: Oral Mucosal w/ histo, 2 extracts Add
SCX275 Irritation: Oral Mucosal w/ histo, Direct exposure Add
SCX210 - Irritation: Intracutaneous Reactivity (USP), 2 extracts
SCX220 - Irritation: Intracutaneous Toxicity (ISO), 2 extracts
SCX230 - Irritation: Primary Eye, 2 extracts
SCX240 - Irritation: Primary Skin, each
SCX250 - Irritation: Bladder, each
SCX260 - Irritation: Vaginal, Direct exposure method for liquids
SCX265 - Irritation: Vaginal, Device method, 2 extracts
SCX270 - Irritation: Oral Mucosal w/ histo, 2 extracts
SCX275 - Irritation: Oral Mucosal w/ histo, Direct exposure

Sample Specifications

SCX210: 2 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX220: 2 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX230: 2 complete device, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT
SCX240: 8 samples, each 1 inch^2 pieces. CSS Approval is needed to meet TAT.
SCX250: Turn Around Time will be determined after CSS approval
SCX260: Minimum 25 mL. CSS Approval is needed to meet TAT.
SCX265: 10 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX270: 3 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX275: 10 discs, sized 1.5cm diameter x 0.5cm thick. CSS Approval is needed to meet TAT.

Study Outline

The intracutaneous irritation test evaluates the safety of a biomaterial sample by injecting rabbits intracutaneously with extracts of the test article and associated vehicle controls. Injection sites will be examined and scored at 24 ± 2, 48 ± 2 and 72 ± 2 hours after treatment for signs of skin reactions.
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