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Batch monitoring – the user’s liability

The sterilization processing of medical devices has to be carried out with validated methods according to the European Medical Device Directive (MDD). A validated process has to be efficient (approved by a validation procedure) and shall not unnoticeable change during daily operation. The requirement for reproducible results applies to all validated processes in all industrial areas, as well in health care. Therefore, a validated process always includes routine monitoring to be able to detect any changes of the process parameters.

Routine monitoring is required in the validation standard (EN ISO 17665-1) for steam sterilization processes. The standard describes tests that have to be carried out during validation and afterwards for routine monitoring (user