Preliminary study on technical specifications and evaluation methods for 3D-printed radiotherapy X-ray dose compensators
10.13491/j.issn.1004-714X.2026.01.025
- VernacularTitle:3D打印放射治疗X射线剂量补偿物技术指标及评价方法初探
- Author:
Liping HE
1
;
Xiaofang GU
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing 100081, China.
- Publication Type:Commentary
- Keywords:
Radiotherapy;
3D-printed X-ray dose compensator;
Technical specification;
Performance evaluation
- From:
Chinese Journal of Radiological Health
2026;35(1):153-158
- CountryChina
- Language:Chinese
-
Abstract:
The 3D-printed radiotherapy X-ray dose compensators can significantly improve the spatial accuracy of radiation dose distribution and the homogeneity of the target volume in superficial tumor radiotherapy while reducing the dose to normal tissues by conforming to individual patient surface contours. Their clinical application value is becoming increasingly prominent. However, standardized evaluation systems or technical specifications for such products are currently lacking both domestically and internationally, leading to inconsistent performance assessment and hindering the verification of their clinical safety and effectiveness. To ensure radiotherapy quality and patient health and safety, this study proposed a set of technical specifications for evaluating radiotherapy X-ray dose compensators by reviewing their physical, functional, and safety performance, as well as software and clinical-engineering interaction performance. Furthermore, based on existing technical standards and regulatory review guidelines, quantitative evaluation methods were explored, including computed tomography number calibration phantom testing and dose compensation performance verification. This work aims to provide a scientific reference for future product development, standard formulation, and regulatory review.
