Table 2 The grading system for intracutaneous (intradermal) reactions
From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®
Reaction | Numerical grading |
|---|---|
Erythema and eschar formation | |
No erythema | 0 |
Very slight erythema (barely perceptible) | 1 |
Well defined erythema | 2 |
Moderate erythema | 3 |
Severe erythema (beet redness) to eschar formation preventing grading of erythema | 4 |
Oedema formation | |
No oedema | 0 |
Very slight oedema (barely perceptible) | 1 |
Well defined oedema (edges of area well defined by define raising) | 2 |
Moderate oedema (edges raised approximately 1 mm) | 3 |
Severe oedema (raised more than 1 mm and extended beyond exposure area) | 4 |