Material mediated Rabbit Pyrogen Assay

1. Biological Effect: Material mediated pyrogenicity
2. Turnaround time: 4 weeks
3. Sample Requirements:

ISO

1200 cm² (test item < 0.5 mm thick);
600 cm² (test item ≥ 0.5 mm thick);
40 grams;
at least 1 item;

4. Animal Quantity: 3 rabbits

ISO 10993-11

The purpose of the study is to determine the risk of a febrile reaction as a result of the administration of the medical device extract. The test item extract is administered by intravenous injection into 3 New Zealand White rabbits. The rectal temperatures of the injected rabbits are compared with the temperature of a control rabbit similarly injected. The baseline temperatures of the rabbits, as determined no more than 30 minutes prior to injection of the medical device, are used to exclude rabbits whose body temperatures vary by more than 1 °C from each other and whose temperatures are greater than 39.8 °C. Body temperatures are recorded in 30 minute intervals between 1 h and 3 h subsequent to injection. If no rabbit exhibits a rise in temperature of 0.5 °C or more above its baseline temperature, the medical device meets the requirements for the absence of pyrogens.