scope:

This 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 generated from machine sources operated at or below and energy level of 10 MeV. This standard specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process. The manufacture of the product has responsibility for the quality of the product including the selection of dose and the attainment of the required sterility assurance level (SAL). The operator of the radiation sterilizaion facility has responsibility for delivering the stipulated absorbed dose. This standard does not cover the assessment of the suitability of a product for its intended use after radiation sterilization; neither does it cover operator safety.