1. Biological Effect: Irritation or Intracutneous reactivity
2. Turnaround time: 4 weeks
3. Sample Requirements:
120 cm² (test item < 0.5 mm thick);
60 cm² (test item ≥ 0.5 mm thick);
The purpose of the study is to determine local responses to medical device extracts following intracutaneous injections into rabbits. The medical device will be exposed to the assay system directly or through medical device extracts. Extracts of the test item are prepared in a non-polar (cottonseed oil) and/or polar (saline) solutions. Three rabbits are injected intracutaneously with the medical device and control items extracts. The injected sites are examined over a 72 hour period for evidence of tissue reaction such as erythema, edema, or necrosis. Observations are scored according to the Classification System for Scoring Skin Reactions. At the end the scores are used to determine an overall mean reaction score for the medical device vs the corresponding control item. The requirements of the assay are met if the difference of the mean reaction score for the medical device and the control item is 1.0 or less.