Sia Analiz
Sensitization
Sensitization studies are performed to determine whether a polar and/or nonpolar extract obtained from a medical device has the potential to cause adverse local or systemic allergic and/or sensitization after repeated or long-term exposure. Different in vivo tests are available for this purpose: Guinea Pig Maximization Test (Magnusson-Kligman Method), Murine Local Lymph Node Test (LLNA), Buehler Test.
Guinea Pig Maximization Test is frequently performed by expert and experienced personnel in SIA Analysis Laboratories with GLP declaration of conformity. If there is a specific request, LLNA or Buehler tests are also performed. Sensitization tests are carried out in accordance with the principles within ISO 10993-10.
