Version: 1.1.5037.23448-7fe1cda529b97ebc52da0f2bbefb0d41deb9638a

Item was added to the Sample Submission form

Item was added to the Quote Request form

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

Pricing/Quote

Test Price Request Quote
SCX110 - Sensitization: Magnusson-Kligman Method, 2 extracts
Per test1+Quote
Add
SCX111 - Sensitization (GLP): Magnusson-Kligman Method, 2 extracts
Per test1+Quote
Add
SCX115 - Sensitization: Magnusson-Kligman Method, liquid/chemical
Per test1+Quote
Add
SCX116 - Sensitization (GLP): Magnusson-Kligman Method, liquid/chemical
1+Quote
Add
SCX130 - Sensitization: Buehler Method, Patch Test
Per test1+Quote
Add
SCX131 - Sensitization (GLP): Buehler Method, Patch Test
1+Quote
Add
SCX110 - Sensitization: Magnusson-Kligman Method, 2 extracts
Per test1+Quote
SCX111 - Sensitization (GLP): Magnusson-Kligman Method, 2 extracts
Per test1+Quote
SCX115 - Sensitization: Magnusson-Kligman Method, liquid/chemical
Per test1+Quote
SCX116 - Sensitization (GLP): Magnusson-Kligman Method, liquid/chemical
1+Quote
SCX130 - Sensitization: Buehler Method, Patch Test
Per test1+Quote
SCX131 - Sensitization (GLP): Buehler Method, Patch Test
1+Quote

Turn Around Time

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your 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.