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YY/T 1901-2023 English PDF

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YY/T 1901-2023: Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1901-2023	English	519	Add to Cart	5 days [Need to translate]	Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology	Valid	YY/T 1901-2023

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Basic data

Standard ID	YY/T 1901-2023 (YY/T1901-2023)
Description (Translated English)	Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C43
Classification of International Standard	11.040.51
Word Count Estimation	26,292
Date of Issue	2023-09-05
Date of Implementation	2024-09-15
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the technical requirements for orthopedic surgery navigation equipment using robotic technology (hereinafter referred to as orthopedic surgery navigation equipment) and describes the corresponding test methods. This standard applies to navigation equipment for orthopedic surgeries (such as joint replacement surgery, spine surgery, orthopedic trauma, etc.).

YY/T 1901-2023: Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.51 CCSC43 Pharmaceutical Industry Standards of the People's Republic of China Orthopedic surgery navigation device using robotic technology Requirements and test methods Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration

PrefaceⅠ 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Requirements 3 4.1 General requirements 3 4.2 Performance of robotic arm positioning device 3 4.3 Tracking device performance3 4.4 System performance 4 4.5 Installation repeatability 4 4.6 Protection function 4 4.7 Orthopedic power surgery equipment 5 4.8 Liquid cooling 5 4.9 Positioning accessory requirements 5 4.10 Software Requirements 6 5 Test method 7 5.1 General requirements 7 5.2 Performance of robotic arm positioning device 7 5.3 Tracking device performance7 5.4 System performance10 5.5 Installation repeatability14 5.6 Protection functions 15 5.7 Orthopedic powered surgical equipment 18 5.8 Liquid cooling 18 5.9 Positioning accessory requirements 18 5.10 Software Requirements18 Appendix A (informative) Orthopedic surgical navigation equipment and accessories 19 Appendix B (informative) Maximum end deflection test point 20 of the robot arm under payload Appendix C (informative) System accuracy test phantom 21 Reference 22

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the responsible unit for medical robot standardization technology. This document was drafted by. China Institute of Food and Drug Control, Medical Device Technical Review Center of the State Food and Drug Administration, Shanghai Municipal Medical Device Inspection and Testing Institute, Beijing Jishuitan Hospital, Chinese People's Liberation Army General Hospital, Liaoning Provincial Medical Device Inspection and Testing Institute, Beijing Tianzhi Hang Medical Technology Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., Gushengyuanhua Robot (Shenzhen) Co., Ltd., Huake Precision (Beijing) Beijing) Medical Technology Co., Ltd. The main drafters of this document. Meng Xiangfeng, Peng Liang, Zhang Lihai, Wang Jing, Hong Wei, Tian Wei, Zhang Longda, Wang Hao, Zhang Chao, Hao Ye, Han Xiaoguang, Jin Lukai, Xu Jin, Li Lu, Yan Tingfang, Liu Wenbo, Wang Chenxi, Li Shu, Li Jiage, and Li Jingli. Orthopedic surgery navigation device using robotic technology Requirements and test methods

1 Scope

This document specifies the technical requirements for orthopedic surgery navigation equipment using robotic technology (hereinafter referred to as "orthopedic surgery navigation equipment"). Corresponding test methods are described. This document applies to navigation equipment for orthopedic surgeries (such as joint replacement surgery, spine surgery, trauma orthopedics, etc.).

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated reference documents, only the version corresponding to the date applies to this document; for undated referenced documents, the new version (including all amendments) applies to this document. document. GB/T 4340.1 Vickers hardness test of metallic materials Part 1.Test methods GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods YY/T 0149 Test method for corrosion resistance of medical stainless steel YY/T 0752 Electric Bone Tissue Surgery Equipment YY/T 1601 Ultrasonic bone tissue surgery equipment YY/T 1712-2021 Auxiliary surgical equipment and auxiliary surgical systems using robotic technology Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The terms and definitions defined in YY/T 1712-2021 and the following apply to this document. 3.1 It consists of a computer with relevant software, a tracking device, etc., which can track surgical instruments, robotic arm positioning devices, or treatment objects, and Devices that provide real-time feedback through digital model visualization. Note. For the schematic diagram, refer to A.1 in Appendix A. [Source. ASTMF2554-18, 3.2.7, modified] 3.2 referenceelement A tool applied to a surgical instrument, treatment object, positioning system, or other device to determine its position in three-dimensional space through a tracking device. Intermittent position and posture. Note. Commonly used reference devices include treatment object reference devices (reference devices that are applied to treatment objects or other devices and allow tracking of the object), positioning Reference device (a reference device applied to a positioning system, imaging system or other device and allowing tracking of the object), tracking reference device (applied to the hand A reference device on a surgical instrument or implant that allows tracking of the object), etc. [Source. ASTMF2554-18, 3.2.8, modified]

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