EN 554:1994

1.1 This European Standard specifies the requirements for the process development, validation, process control and monitoring of the sterilization of medical devices using moist heat. 1.2 The method is based on the monitoring of physical factors that cause the product to become sterile and presuppose that prior to validation the sterilizer and its installation comply with an appropriate specification. Note: Specifications for sterilizers are being prepared by CEN/TC 102. 1.3 This European Standard does not describe a quality assurance system for the control of all stages of manufacture. Note: Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text. 1.4 This European Standard does not address the routine testing of samples (sterility testing) or the use of biological indicators as, except in a limited number of special applications, 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.