1 This European Standard specifies requirements for the process development, validation, process control and monitoring of the sterilization of medical devices using moist heat.
2 The 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 comply with an appropriate specification.
NOTE. Specifications for sterilizers are being prepared by CENTC 102.
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 460011 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.
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.
DS/EN 554:1994 history
2006DS/EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
1994DS/EN 554:1994 Sterilization of medical devices - Validation and routine control of sterilization by moist heat