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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 G95-1 Guidelines]

Applicable Standards

  • ISO 10993

Test Options

Standard turn around times (TAT) are listed below. 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 TAT (days) Request Quote
SCX210 Irritation: Intracutaneous Reactivity (USP), 2 extracts 35 Add
SCX220 Irritation: Intracutaneous Toxicity (ISO), 2 extracts 40 Add
SCX230 Irritation: Primary Eye, 2 extracts 35 Add
SCX240 Irritation: Primary Skin, each 35 Add
SCX250 Irritation: Bladder, each Add
SCX260 Irritation: Vaginal, Direct exposure method for liquids 56 Add
SCX265 Irritation: Vaginal, Device method, 2 extracts 56 Add
SCX270 Irritation: Oral Mucosal w/ histo, 2 extracts 70 Add
SCX275 Irritation: Oral Mucosal w/ histo, Direct exposure 70 Add
SCX210 - Irritation: Intracutaneous Reactivity (USP), 2 extracts
TAT: 35 days
SCX220 - Irritation: Intracutaneous Toxicity (ISO), 2 extracts
TAT: 40 days
SCX230 - Irritation: Primary Eye, 2 extracts
TAT: 35 days
SCX240 - Irritation: Primary Skin, each
TAT: 35 days
SCX250 - Irritation: Bladder, each
Standard TAT not available for this product
SCX260 - Irritation: Vaginal, Direct exposure method for liquids
TAT: 56 days
SCX265 - Irritation: Vaginal, Device method, 2 extracts
TAT: 56 days
SCX270 - Irritation: Oral Mucosal w/ histo, 2 extracts
TAT: 70 days
SCX275 - Irritation: Oral Mucosal w/ histo, Direct exposure
TAT: 70 days

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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