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
