T/GDPHA 002-2025 Guidelines for Reporting Adverse Events of Medical Electron Beam Accelerators

Scope

Scope: This document specifies the scope, types, methods, and time limits for reporting adverse events of medical electron linear accelerators, and provides a reporting form for adverse events of medical electron linear accelerators. This document applies to organizations such as holders, operating enterprises, and users of medical electron linear accelerators, which are typically composed of frames, radiation heads, treatment beds, control consoles, image-guided devices, etc., in conducting adverse event monitoring of medical electron linear accelerators. The classification code of the medical electron linear accelerators mentioned in this document in the *Classification Catalogue of Medical Devices* (2017) is 05-01-01. This document does not apply to adverse events of non-medical electron linear accelerators. This document was developed based on current regulations and the current level of technological understanding. As regulations continue to improve and scientific technology continues to develop, the relevant content of this document will be adjusted in a timely manner. Main technical content: According to the provisions of the *Regulations on Monitoring and Re-evaluation of Adverse Events of Medical Devices*, a dataset is established based on the National Adverse Event Monitoring Information System and the Guangdong Province Medical Device Adverse Event Key Monitoring Information System to analyze adverse event reports of medical electron linear accelerators. After discussion by an expert group, reporting standards for individual adverse events of medical electron linear accelerators are formulated.

Development Information

Related Standards