Requirement of the European Medical Device Directive (MDD) 93/42 ECC

Sterility of goods coming out of a sterilizer cannot be checked before use. To assure sterility of products coming out of a sterilization process a validation process is required. It is required to assure, that:

1 products coming out of the sterilization process are sterile with a sterility assurance level of SAL ? 10-6 CFU (according to EN 556)

2 Reproducibility of sterility is guaranteed over a long time
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