EN 552:1994

EN 552:1994 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 irradiation". This standard covers: 1.1 This European Standard specifies requirements for the validation, process control and monitoring of the radiation sterilization of medical devices. It is applicable to continuous and batch type gamma irradiators using the radionuclides 60Co or 137Cs and to irradiators using electrons, at or below an energy level of 10 MeV, generated from machine sources. 1.2 This European Standard specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process. 1.3 This European Standard does not describe a quality assurance system for 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 stystem 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 covers the determination of the maximum dose but does not cover specifically the assessment of the suitability of a product for its intended use after radiation sterilization. 1.5 This European Standard does not cover radiation protection requirements associated with operating irradiation plants. Note: Attention is drawn to the existence in some countries of national regulations laying down safety requirements when operating irradiation plants.

1.1 This European Standard specifies requirements for the validation, process control and monitoring of the radiation sterilization of medical devices. It is applicable to continuous and batch type gamma irradiators using the radionuclides 60Co or 137Cs and to irradiators using electrons, at or below an energy level of 10 MeV, generated from machine sources. 1.2 This European Standard specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process. 1.3 This European Standard does not describe a quality assurance system for 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 stystem 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 covers the determination of the maximum dose but does not cover specifically the assessment of the suitability of a product for its intended use after radiation sterilization. 1.5 This European Standard does not cover radiation protection requirements associated with operating irradiation plants. Note: Attention is drawn to the existence in some countries of national regulations laying down safety requirements when operating irradiation plants.

EN 552:1994 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 552:1994 has the following relationships with other standards: It is inter standard links to EN ISO 11137-1:2006, EN ISO 11137-3:2006, EN ISO 11137-2:2006, EN 552:1994/A1:1999, EN 552:1994/A2:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 552:1994 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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