ILT-MC-0197
Microbiological Testing of Medical Devices
DETERMINATION | METHOD |
| Bioburden Total number of microorganisms (Before sterilization) Quantitative (CFU/ml) | USP <61> |
| Specified microorganisms Qualitative (Presence/Absence) | USP <62> |
| Bacterial endotoxin Qualitative (Presence/Absence) | GEL CLOT USP <85> |
| Sterility (After sterilization) Qualitative (Presence/Absence) | USP <71> |
