Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology
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 M...
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| Format: | Article |
| Language: | zho |
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Editorial Office of Medical Journal of Peking Union Medical College Hospital
2025-07-01
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| Series: | Xiehe Yixue Zazhi |
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| Online Access: | https://xhyxzz.pumch.cn/article/doi/10.12290/xhyxzz.2025-0443 |
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| _version_ | 1849240644181032960 |
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| author | TANG Qiaohong MENG Xiangfeng WANG Hao LI Shu |
| author_facet | TANG Qiaohong MENG Xiangfeng WANG Hao LI Shu |
| author_sort | TANG Qiaohong |
| collection | DOAJ |
| description | 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 requirements 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 accessory requirements, and software requirements. Additionally, it standardizes quality evaluation methods, providing significant guidance for advancing robotic technology, accelerating product market entry, and strengthening regulatory oversight. This article analyzes the key components of the standard to facilitate better qualityassessment of products and promote high-quality development within the industry. |
| format | Article |
| id | doaj-art-7ca7dd227fd148e3898ac5d698cf88d6 |
| institution | Kabale University |
| issn | 1674-9081 |
| language | zho |
| publishDate | 2025-07-01 |
| publisher | Editorial Office of Medical Journal of Peking Union Medical College Hospital |
| record_format | Article |
| series | Xiehe Yixue Zazhi |
| spelling | doaj-art-7ca7dd227fd148e3898ac5d698cf88d62025-08-20T04:00:28ZzhoEditorial Office of Medical Journal of Peking Union Medical College HospitalXiehe Yixue Zazhi1674-90812025-07-0116490891510.12290/xhyxzz.2025-0443Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic TechnologyTANG Qiaohong0MENG Xiangfeng1WANG Hao2LI Shu3National Institutes for Food and Drug Control, Beijing 100050, ChinaNational Institutes for Food and Drug Control, Beijing 100050, ChinaNational Institutes for Food and Drug Control, Beijing 100050, ChinaNational Institutes for Food and Drug Control, Beijing 100050, ChinaIn 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 requirements 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 accessory requirements, and software requirements. Additionally, it standardizes quality evaluation methods, providing significant guidance for advancing robotic technology, accelerating product market entry, and strengthening regulatory oversight. This article analyzes the key components of the standard to facilitate better qualityassessment of products and promote high-quality development within the industry.https://xhyxzz.pumch.cn/article/doi/10.12290/xhyxzz.2025-0443medical surgical robotssurgical navigation equipmentstandard analysistest method |
| spellingShingle | TANG Qiaohong MENG Xiangfeng WANG Hao LI Shu Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology Xiehe Yixue Zazhi medical surgical robots surgical navigation equipment standard analysis test method |
| title | Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology |
| title_full | Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology |
| title_fullStr | Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology |
| title_full_unstemmed | Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology |
| title_short | Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology |
| title_sort | interpretation of sectoral standard requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology |
| topic | medical surgical robots surgical navigation equipment standard analysis test method |
| url | https://xhyxzz.pumch.cn/article/doi/10.12290/xhyxzz.2025-0443 |
| work_keys_str_mv | AT tangqiaohong interpretationofsectoralstandardrequirementsandtestmethodsfororthopaedicsurgicalnavigationequipmentemployingrobotictechnology AT mengxiangfeng interpretationofsectoralstandardrequirementsandtestmethodsfororthopaedicsurgicalnavigationequipmentemployingrobotictechnology AT wanghao interpretationofsectoralstandardrequirementsandtestmethodsfororthopaedicsurgicalnavigationequipmentemployingrobotictechnology AT lishu interpretationofsectoralstandardrequirementsandtestmethodsfororthopaedicsurgicalnavigationequipmentemployingrobotictechnology |