Table 4 Criteria of acceptance for the pyrogenicity test
From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®
Number of rabbits | Product passes if the summary response does not exceed | The product fails if the summary response exceeds |
|---|---|---|
3 | 1.15 ̊C | 2.65 ̊C |
6 | 2.80 ̊C | 4.30 ̊C |
9 | 4.45 ̊C | 5.95 ̊C |
12 | 6.60 ̊C | 6.60 ̊C |