Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology
10.12290/xhyxzz.2025-0443
- VernacularTitle:行业标准《采用机器人技术的骨科手术导航设备要求及试验方法》解析
- Author:
Qiaohong TANG
1
;
Xiangfeng MENG
1
;
Hao WANG
1
;
Shu LI
1
Author Information
1. 中国食品药品检定研究院,北京 100050
- Publication Type:Journal Article
- Keywords:
medical surgical robots;
surgical navigation equipment;
standard analysis;
test method
- From:
Medical Journal of Peking Union Medical College Hospital
2025;16(4):908-915
- CountryChina
- Language:Chinese
-
Abstract:
In recent years,robot-assisted technology has become increasingly sophisticated in the field of orthopedic surgical navigation.To ensure surgical safety and protect patient rights,corresponding products must undergo rigorous and standardized pre-market quality evaluations.In 2023,the National Medical Products Administration issued the sectoral standard YY/T 1901-2023 Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology.This standard specifies the performance require-ments for robotic orthopedic surgical navigation systems across ten key aspects:general requirements,robotic arm positioning device performance,tracking device performance,system performance,installation repeatability,protective functions,orthopedic powered surgical instruments,liquid cooling,positioning acces-sory requirements,and software requirements.Additionally,it standardizes quality evaluation methods,provi-ding significant guidance for advancing robotic technology,accelerating product market entry,and strengthe-ning regulatory oversight.This article analyzes the key components of the standard to facilitate better quality assessment of products and promote high-quality development within the industry.
