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Basic data Standard ID | YY/T 1686-2024 (YY/T1686-2024) | Description (Translated English) | Medical electrical equipment employing robotic technology - Terminology, definitions and classification | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C30 | Classification of International Standard | 11.040 | Word Count Estimation | 22,296 | Date of Issue | 2024-09-29 | Date of Implementation | 2025-10-15 | Older Standard (superseded by this standard) | YY/T 1686-2020 | Issuing agency(ies) | State Drug Administration | Summary | This standard specifies the terms, definitions and classifications of medical electrical equipment or medical electrical systems using robotic technology. |
YY/T 1686-2024: Medical electrical equipment employing robotic technology - Terminology, definitions and classification ---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
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1686-2020
Medical electrical equipment using robotics
Terms, definitions, classifications
Released on 2024-09-29
Implementation on October 15, 2025
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Robot equipment classification 13
Appendix A (Informative) Principle Description 15
References 16
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY/T 1686-2020 "Classification of medical electrical equipment using robotic technology" and is compatible with YY/T 1686-2020
Compared with the previous version, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Changed the "Scope" (see Chapter 1, Chapter 1 of the 2020 edition);
--- Added "Normative references" (see Chapter 2);
--- Added the terms "robot" (see 3.1.1), "autonomy" (see 3.1.2), "robotics" (see 3.1.3), "medical machine
"people" (see 3.1.7), "computer-assisted surgical equipment" (see 3.1.8), "assisted surgical equipment using robotic technology" (see
3.1.10), “assisted surgical system using robotic technology” (see 3.1.11), “human-computer interaction” (see 3.1.16), “teleoperation” (see
3.2.1.1), "pose" (see 3.2.1.2), "command pose" (see 3.2.1.3), "path" (see 3.2.1.4), "mechanical interface" (see
3.2.1.7), “Telecentric fixed point” (see 3.2.1.8), “Surgical navigation” (3.2.2), “Medical machines for rehabilitation, assessment, compensation and relief”
"People" (3.2.3.1), "Mitigation" (3.2.3.4), "Assessment" (3.2.3.5), "Drive Application Part" (3.2.3.13), "Rehabilitation Training"
(3.2.3.14), "Active Assistance Training" (3.2.3.15), "Resistance Training" (3.2.3.16), "Structural Composition" (3.3), "Performance"
(3.4);
--- Changed the terms "medical electrical equipment/system using robotic technology" (see 3.1.6, 2.1 of the 2020 edition), "medical electrical
Equipment” (see 3.1.4, 2.3 of the 2020 edition), “Medical Electrical Systems” (see 3.1.5, 2.4 of the 2020 edition), “Surgery”
(see 3.1.9, 2.5 of the 2020 edition), “rehabilitation” (see 3.2.3.2, 2.6 of the 2020 edition), “compensation” (see 3.2.3.3,
2.7 of the 2020 edition), “injury” (see 3.2.3.6, 2.8 of the 2020 edition), “motor function” (see 3.2.3.7, 2.9 of the 2020 edition), “human
"Human body function" (see 3.1.12, 2020 version 2.10), "Human body structure" (see 3.1.13, 2020 version 2.11), "Master-slave control"
(see 3.2.1.5, 2020 edition 2.14), "collaborative operation" (see 3.2.1.6, 2020 edition 2.15), "hand-held" (see
3.2.3.8, 2020 version 2.16), "wearable" (see 3.2.3.9, 2020 version 2.17), "passive training" (see
3.2.3.16, 2.23 of the 2020 edition), “home care environment” (see 3.2.3.20, 2.27 of the 2020 edition);
--- The terms "axis" (see 2.2 of the 2020 version), "active training" (see 2.21 of the 2020 version), and "assisted training" (see
2.22 of the 2020 edition);
--- Changed "Surgical robotic equipment" (see 4.1.1, 3.1.1 of the 2020 edition);
--- Changed "Medical robotic equipment for rehabilitation, assessment, compensation and relief" (see 4.1.2, 3.1.2 of the 2020 edition);
--- Added "other robot equipment" (see 4.1.3) and "according to control mode" (see 4.4);
--- Deleted "for compensation" (see 3.1.3 of the 2020 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the medical robot standardization technical authority.
This document was drafted by. China Food and Drug Inspection Institute, National Medical Products Administration Medical Device Technical Evaluation Center, Shanghai
Medical Device Inspection Institute, Tianjin University, Beijing Surui Robotics Co., Ltd., Soochow University, Guangdong Jiahuamei Certification Co., Ltd.,
Chinese PLA General Hospital, Shenzhen University of Technology, Intuitive Fosun Medical Device Technology (Shanghai) Co., Ltd.
The main drafters of this document are. Zheng Jia, Meng Xiangfeng, Zhang Chenguang, Chen Huiming, He Kunlun, Xu Kai, Zhang Ting, Xing Yuan, Kuang Chao, Kuang Shaolong, Wang Hao,
Zhang Chao and Zhang Yijia.
This document was first published in 2020 and this is the first revision.
Medical electrical equipment using robotics
Terms, definitions, classifications
1 Scope
This document defines medical electrical equipment using robotic technology (hereinafter referred to as robotic equipment) or medical electrical systems (hereinafter referred to as
The terminology and definitions of robot systems are defined and their classification is specified.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance
YY 9706.277 Medical electrical equipment Part 2-77.Basic safety and basic requirements for surgical assistance equipment using robotic technology
Performance-specific requirements
YY 9706.278 Medical electrical equipment Part 2-78.Basic safety and use of medical robots for rehabilitation, assessment, compensation or relief
Special requirements for basic performance
3 Terms and definitions
The terms and definitions defined in GB 9706.1, YY 9706.277, YY 9706.278 and the following apply to this document.
3.1 Basic general terms
3.1.1
robot
A program-driven mechanism with a certain degree of autonomous capability to perform movement, manipulation or positioning.
Note 1 to entry. A robot includes a control system.
Note 2.The mechanical structure of the robot, such as manipulators, mobile platforms and wearable robots.
[Source. ISO 8373.2021,3.1]
3.1.2
Autonomy
The ability to perform intended tasks without human intervention based on current state and sensory information.
Note. For the classification of autonomous capabilities, see IEC /T R60601-4-1.
[Source. ISO 8373.2021,3.2]
3.1.3
Robotic Technology
Knowledge of practical applications commonly used in the design of robots or their control systems, especially knowledge to improve their autonomous capabilities.
Examples. perception, reasoning, and planning algorithms.
[Source. ISO 8373.2021, 3.3]
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