This document specifies the management and quality control requirements for the operation, operation and maintenance of electron accelerator devices for radiation processing. This document applies to electron accelerator devices for radiation processing that generate electron beam energy of 0.3 MeV to 10 MeV and X-ray energy not greater than 5 MeV. The electron accelerator device for radiation processing with electron beam energy lower than 300keV can be implemented as a reference.
GB/T 40590-2021 Referenced Document
GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.2 Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
GB 18871 Basic standards for protection against ionizing radiation and for the safety of radiation sources
GB/T 16841-2008 Guide for dosimetry in an electron beam facility for radiation processing at energies between 300 keV~25MeV
GB/T 25306-2010 Standard of electron accelerator facility engineering for radiation processing
HJ 979-2018 Radiation Safety and Protection of Electron Accelerator Irradiation Facility
GB/T 40590-2021 history
2021GB/T 40590-2021 Specification for operation and maintenance management of electron accelerator facility for radiation processing