Standard No.:	YY/T 1901-2023
English Name:	Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology
Chinese Name:	采用机器人技术的骨科手术导航设备要求及试验方法
Chinese Classification:	C43    Medical radiographic equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	National Medical Products Adminstration
Issued on:	2023-09-05
Implemented on:	2024-9-15
Status:	valid
Language:	English
File Format:	PDF
Word Count:	12500 words
Price(USD):	375.0
Delivery:	via email in 1 business day

YY/T 1901-2023 Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology 1 Scope This document specifies the technical requirements for orthopaedic surgical navigation equipment employing robotic technology (hereinafter referred to as "orthopaedic surgical navigation equipment") and describes the corresponding test methods. This document is applicable to navigation equipment in orthopaedic surgery (e.g. joint replacement surgery, spine surgery, trauma orthopaedics, etc.). 2 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods YY/T 0149 Medical instruments of stainless steel - Test methods of corrosion resistance YY/T 0752 Electrical surgical equipment for osseous tissue YY/T 1601 Ultrasonic surgical equipment for osseous tissue YY/T 1712-2021 Assisted surgical medical equipment and assisted surgical medical system employing robotic technology Pharmacopoeia of the People's Republic of China 3 Terms and definitions For the purposes of this standard, the terms and definitions given in YY/T 1712-2021 as well as the followings apply. 3.1 surgical navigation equipment equipment composed of computers with relevant software and trackers, capable of tracking surgical instruments, robotic manipulator positioning equipment, or subjects, and providing real-time feedback through digital model visualization Note: Refer to A.1 in Annex A for the schematic diagram. [Source: ASTM F2554-18, 3.2.7, modified] 3.2 reference element tool applied to surgical instruments, subjects, positioning systems, or other devices that can determine its position and posture in three-dimensional space through a tracker Note: Commonly used reference elements include subject reference elements (applied to a subject or other device and allowing tracking of the subject), positioning reference elements (applied to a positioning system, imaging system or other device and allowing tracking of the subject), tracing reference elements (applied to a surgical instrument or implant and allowing tracking of the subject), and the like. [Source: ASTM F2554-18, 3.2.8, modified] 3.3 tracker apparatus for measuring the spatial position and posture of a surgical instrument, a subject, a robotic manipulator positioning equipment or other equipment, wherein the surgical instrument, subject, robotic manipulator positioning equipment or other equipment is equipped with a reference element Note: The tracker can measure based on optical (including active and passive tracking), ultrasound, electromagnetic field, mechanical linkage, video streaming, etc. [Source: ASTM F2554-18, 3.2.14, modified] 3.4 registration determination of the transformation relationship between the coordinate space of the subject and the digital model, such as a medical image, or the transformation relationship between the coordinate spaces of the two digital models Note: It consists of geometric transformations such as rotation, translation and scaling. [Source: ASTM F2554-18, 3.2.10, modified] 3.5 surgical planning design of surgical protocols performed before or after the start of surgery, including preoperative planning and intraoperative planning Note: Preoperative planning refers to the design of surgical plan based on the patient's preoperative images and other information before the operation starts; intraoperative planning refers to the design of surgical planning based on the patient's intraoperative information, preoperative or intraoperative images, etc. after the operation starts. 3.6 robotic manipulator positioning equipment robotic manipulator that employs robotic technology to position an end effector or end stereotactic device at a specified position in three-dimensional space [Source: ASTM F2554-18, 3.2.11, modified] 3.7 end effector power equipment installed at the end interface of the robotic manipulator to accomplish the surgical task intended by the orthopaedic surgical navigation equipment Example: A bone power system installed at the end of the robotic manipulator and having the functions of milling, sawing, cutting, drilling, etc. [Source: YY/T 1712-2021, 3.17, modified]

Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 4.1 General requirements 4.2 Performance of robotic manipulator positioning equipment 4.3 Tracker performance 4.4 System performance 4.5 Installation repeatability 4.6 Protection function 4.7 Orthopaedic power surgical equipment 4.8 Liquid cooling 4.9 Requirements for positioning accessories 4.10 Software requirements 5 Test methods 5.1 General requirements 5.2 Performance of robotic manipulator positioning equipment 5.3 Tracker performance 5.4 System performance 5.5 Installation repeatability 5.6 Protection function 5.7 Orthopaedic power surgical equipment 5.8 Liquid cooling 5.9 Requirements for positioning accessories 5.10 Software requirements Annex A (Informative) Orthopaedic surgical navigation equipment and accessories Annex B (Informative) Test point of the maximum end offset under robotic manipulator payload Annex C (Informative) System accuracy test phantom Bibliography