This European Standard specifies requirements for the process development, validation, process control and monitoring of the sterilization of medical devices using moist heat. This method is based on the monitoring of the physical factors that cause the product to become sterile and presupposes that prior to validation the sterilizer and its installation conform to an appropriate specification.
This European Standard does not describe a quality assurance system for the control of all stages of manufacture.
This European Standard does not address the routine testing of samples (sterility testing) or the use of biological indicators, except in a limited number of special applications, as these practices are of limited value in moist heat sterilization. In such special applications, they should be regarded as additional to the measurement of physical parameters.