The exemption of X-ray devices refers to X-ray equipment that meets specific criteria and can be exempted from regular radiation safety supervision procedures (such as radiation safety permits), while still being required to comply with basic safety management requirements.
Requirements for X-ray Devices to Apply for Exemption:
(I) Justification Requirement
It is necessary to ensure that the use of the X-ray device is justified.
(II) Public Dose Requirement
In accordance with the requirements of Appendix A1.3 of Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources (GB18871-2002), the effective dose expected to be received by any individual from the exempted X-ray device within one year shall be at the level of 10 μSv or lower.
(III) Technical Requirements for X-ray Devices
The tube voltage and maximum energy of an X-ray device are its main parameters. X-rays are mainly bremsstrahlung generated by the interaction between electron beams and target materials, and they form a continuous energy spectrum composed of photons of various energies. The maximum tube voltage represents the peak voltage for accelerating electrons and can be used to indicate the maximum energy of X-rays in the continuous energy spectrum. The following technical requirements are put forward based on different tube voltages of X-ray devices:
- X-ray devices with a maximum tube voltage lower than 5 kV may be exempted.
- X-ray devices with a maximum tube voltage ranging from 5 kV to 50 kV may be exempted after meeting the following inherent safety and radiation level requirements:
- Inherent safety requirement for X-ray devices: The shielding body shall be designed and manufactured as an integral part of the main structure of the X-ray device, with a standard model and size; under any operating mode, the human body shall not be able to enter or stay inside the shielding body of the X-ray device.
- Radiation level: Under normal operation and operating conditions, the ambient dose equivalent rate or directional dose equivalent rate at a distance of 0.1 m from any accessible surface of the X-ray device shall not exceed 1 μSv/h.
- X-ray devices with a maximum tube voltage higher than 50 kV shall not be included in the exemption management. (Reference: Technical Requirements for Filing of X-ray Device Exemptions – Ministry of Ecology and Environment of the People’s Republic of China)
X-ray Devices
The C-arm/DR devices produced by Perlove Medical are all classified as X-ray devices. Do these devices meet the exemption criteria?
The answer is no. Because the relevant provisions of provincial-level ecological and environmental authorities regarding X-ray devices that are not suitable for exemption clearly include two categories: “X-ray devices used for medical purposes” and “various types of X-ray devices with mobile usage functions”. C-arm/DR devices all belong to medical X-ray devices, and most of them are mobile. Therefore, they will not be included in the exemption management.
