Routine monitoring according EN ISO 17665-1

The sterilizing process must be validated before initial start up, after each major repair, after a certain amount of sterilization cycles or a certain period according to the Medical Device Directive (MDD) and local laws or directives. A validated method proves that the intended result is always reached under the same conditions. The standard EN ISO 17665-1 describes validation and routine monitoring of steam sterilization processes. This standard describes the methods of a validation and how a successful sterilization can be permanently controlled and monitored. A validated process remains efficient it if is reproducible on a day-to-day basis. EN ISO 17665-1 contains well-defined information for the functionality check of the sterilizer (IQ, OQ) as well as for monitoring of each batch:

1. Functionality check of the sterilizer after start-up:

In section 12 (Maintaining process effectiveness) is says literally in 12.1.6: