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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.
Reģistrācijas numurs (WIID)
9285
Darbības sfēra
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.
