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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.

Code Test TAT (days) Request Quote
SCX210 Irritation: Intracutaneous Reactivity (USP), 2 extracts Add
SCX211 Irritation (GLP): Intracutaneous Reactivity (USP), 2 extracts Add
SCX220 Irritation: Intracutaneous Toxicity (ISO), 2 extracts Add
SCX221 Irritation (GLP): Intracutaneous Toxicity (ISO), 2 extracts Add
SCX230 Irritation: Primary Eye, 2 extracts Add
SCX231 Irritation (GLP): Primary Eye, 2 extracts Add
SCX240 Irritation: Primary Skin, each Add
SCX241 Irritation (GLP): Primary Skin, each Add
SCX250 Irritation: Bladder, each Add
SCX251 Irritation (GLP): Bladder, each Add
SCX260 Irritation: Vaginal, Direct exposure method for liquids Add
SCX261 Irritation (GLP): Vaginal, Direct exposure method for liquids Add
SCX265 Irritation: Vaginal, Device method, 2 extracts Add
SCX266 Irritation (GLP): Vaginal, Device method, 2 extracts Add
SCX270 Irritation: Oral Mucosal w/ histo, 2 extracts Add
SCX271 Irritation (GLP): Oral Mucosal w/ histo, 2 extracts Add
SCX275 Irritation: Oral Mucosal w/ histo, Direct exposure Add
SCX276 Irritation (GLP): Oral Mucosal w/ histo, Direct exposure Add
SCX210 - Irritation: Intracutaneous Reactivity (USP), 2 extracts
Standard TAT not available for this product
SCX211 - Irritation (GLP): Intracutaneous Reactivity (USP), 2 extracts
Standard TAT not available for this product
SCX220 - Irritation: Intracutaneous Toxicity (ISO), 2 extracts
Standard TAT not available for this product
SCX221 - Irritation (GLP): Intracutaneous Toxicity (ISO), 2 extracts
Standard TAT not available for this product
SCX230 - Irritation: Primary Eye, 2 extracts
Standard TAT not available for this product
SCX231 - Irritation (GLP): Primary Eye, 2 extracts
Standard TAT not available for this product
SCX240 - Irritation: Primary Skin, each
Standard TAT not available for this product
SCX241 - Irritation (GLP): Primary Skin, each
Standard TAT not available for this product
SCX250 - Irritation: Bladder, each
Standard TAT not available for this product
SCX251 - Irritation (GLP): Bladder, each
Standard TAT not available for this product
SCX260 - Irritation: Vaginal, Direct exposure method for liquids
Standard TAT not available for this product
SCX261 - Irritation (GLP): Vaginal, Direct exposure method for liquids
Standard TAT not available for this product
SCX265 - Irritation: Vaginal, Device method, 2 extracts
Standard TAT not available for this product
SCX266 - Irritation (GLP): Vaginal, Device method, 2 extracts
Standard TAT not available for this product
SCX270 - Irritation: Oral Mucosal w/ histo, 2 extracts
Standard TAT not available for this product
SCX271 - Irritation (GLP): Oral Mucosal w/ histo, 2 extracts
Standard TAT not available for this product
SCX275 - Irritation: Oral Mucosal w/ histo, Direct exposure
Standard TAT not available for this product
SCX276 - Irritation (GLP): Oral Mucosal w/ histo, Direct exposure
Standard TAT not available for this product

Sample Specifications

SCX210: Turn Around Time is 35 days from PDS approval. 2 complete devices, each device must be 120 cm2 or 4 grams.
SCX211: Turn Around Time is 35 days from PDS approval. 2 complete devices, each device must be 120 cm2 or 4 grams.
SCX220: Turn Around Time is 35 days from PDS approval. 2 complete devices, each device must be 120 cm2 or 4 grams.
SCX221: Turn Around Time is 35 days from PDS approval. 2 complete devices, each device must be 120 cm2 or 4 grams.
SCX230: Turn Around Time is 35 days from PDS approval. 2 complete device, each device must be 120 cm2 or 4 grams.
SCX231: Turn Around Time is 35 days from PDS approval. 2 complete device, each device must be 120 cm2 or 4 grams.
SCX240: Turn Around Time is 35 days from PDS approval. 8 samples, each 1 inch^2 pieces
SCX241: Turn Around Time is 35 days from PDS approval. 8 samples, each 1 inch^2 pieces
SCX250: Turn Around Time will be determined after PDS approval
SCX251: Turn Around Time will be determined after PDS approval
SCX260: Turn Around Time is 56 days from PDS approval. Minimum 25 mL.
SCX261: Turn Around Time is 56 days from PDS approval. Minimum 25 mL.
SCX265: Turn Around Time is 56 days from PDS approval. 10 complete devices, each device must be 120 cm2 or 4 grams.
SCX266: Turn Around Time is 56 days from PDS approval. 10 complete devices, each device must be 120 cm2 or 4 grams.
SCX270: Turn Around Time is 70 days from PDS approval. 3 complete devices, each device must be 120 cm2 or 4 grams.
SCX271: Turn Around Time is 70 days from PDS approval. 3 complete devices, each device must be 120 cm2 or 4 grams.
SCX275: Turn Around Time is 70 days from PDS approval. 10 discs, sized 1.5cm diameter x 0.5cm thick.
SCX276: Turn Around Time is 70 days from PDS approval. 10 discs, sized 1.5cm diameter x 0.5cm thick.

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.