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]
- ISO 10993
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|SCX110||Sensitization: Magnusson-Kligman Method, 2 extracts||Add|
|SCX115||Sensitization: Magnusson-Kligman Method, liquid/chemical||Add|
|SCX130||Sensitization: Buehler Method, Patch Test||Add|
SCX110 - Sensitization: Magnusson-Kligman Method, 2 extracts
TAT: 61 days
SCX115 - Sensitization: Magnusson-Kligman Method, liquid/chemical
TAT: 56 days
SCX130 - Sensitization: Buehler Method, Patch Test
TAT: 68 days
SCX110: 6 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT
SCX115: 25 mL. CSS Approval is needed to meet TAT.
SCX130: 116 samples, each 1 inch^2 pieces. CSS Approval is needed to meet TAT.