EN 554:1994

EN 554:1994 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterilization of medical devices - Validation and routine control of sterilization by moist heat". This standard covers: 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.

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.

EN 554:1994 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 554:1994 has the following relationships with other standards: It is inter standard links to EN ISO 17665-1:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 554:1994 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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