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Sensitization Testing

Sensitization Testing

The Biocompatibility Sensitization test evaluates the potential of a material or product to cause a sensitizing effect or allergenic reaction in a patient over an extended period of exposure. Sensitization or hypersensitivity is tested by exposing an animal’s skin to the material, or taking extracts from the device/material and injecting and/or topically applying them, and looking for adverse reactions. Sensitization reactions are noted by observing redness and swelling as it interacts with the body’s immune system. 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
SCX110 Sensitization: Magnusson-Kligman Method, 2 extracts Add
SCX111 Sensitization (GLP): Magnusson-Kligman Method, 2 extracts Add
SCX115 Sensitization: Magnusson-Kligman Method, liquid/chemical Add
SCX116 Sensitization (GLP): Magnusson-Kligman Method, liquid/chemical Add
SCX130 Sensitization: Buehler Method, Patch Test Add
SCX131 Sensitization (GLP): Buehler Method, Patch Test Add
SCX110 - Sensitization: Magnusson-Kligman Method, 2 extracts
Standard TAT not available for this product
SCX111 - Sensitization (GLP): Magnusson-Kligman Method, 2 extracts
Standard TAT not available for this product
SCX115 - Sensitization: Magnusson-Kligman Method, liquid/chemical
Standard TAT not available for this product
SCX116 - Sensitization (GLP): Magnusson-Kligman Method, liquid/chemical
Standard TAT not available for this product
SCX130 - Sensitization: Buehler Method, Patch Test
Standard TAT not available for this product
SCX131 - Sensitization (GLP): Buehler Method, Patch Test
Standard TAT not available for this product

Sample Specifications

SCX110: Turn Around Time is 56 days from PDS approval. 6 complete devices, each device must be 120 cm2 or 4 grams.
SCX111: Turn Around Time is 56 days from PDS approval. 6 complete devices, each device must be 120 cm2 or 4 grams.
SCX115: Turn Around Time is 56 days from PDS approval. 25 mL.
SCX116: Turn Around Time is 56 days from PDS approval. 25 mL.
SCX130: Turn Around Time is 63 days from PDS approval. 116 samples, each 1 inch^2 pieces.
SCX131: Turn Around Time is 63 days from PDS approval. 116 samples, each 1 inch^2 pieces.

Study Outline

In the Biocompatibility Sensitization test, guinea pigs will be exposed in two induction phases to extracts of the test article or control. Following induction phases, the animals will be on a rest period after which they are challenged at a naïve skin site with the test article extracts or control vehicles. The challenge sites of each animal will be observed for evidence of skin sensitization 24 ± 2 and 48 ± 2 hours after removal of the test article extracts or control vehicles.