1. Biological Effect: Sensitization
2. Turnaround time: 12 weeks
3. Sample Requirements:
120 pieces of 2.5 cm x 2.5 cm patches each;
4. Animal Quantity: 20 or 35 guinea pigs
The purpose of the study is to determine the sensitizing capacity or allergenic potential of the medical device in guinea pigs. The test item is exposed to the assay system by direct application. In the “induction phase” the medical is applied topically to the skin as closed patches, for 3 exposures per 1 week for 3 weeks. 14 days after the induction phase, the challenge assay will be performed by the application of an assay patch to new sites and observed for edema and erythema at 24 and 48 hours. A sensitization reaction to the medical device (or extract) is scored based on the defined evaluation criteria in ISO 10993-10.