YY/T 1686-2024Medical electrical equipment employing robotic technology - Terminology, definitions and classification (English PDF)
采用机器人技术的医用电气设备 术语、定义、分类
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 29, 2024
Implementation date
October 15, 2025
Scope
YY/T 1686-2024 is the English-translated version of 采用机器人技术的医用电气设备 术语、定义、分类.
YY/T 1686 is the terminology and classification standard that the whole Chinese medical robotics framework rests on. It fixes the terms and definitions for medical electrical equipment employing robotic technology and sets out how such equipment is classified. Every one of the surgical robot standards cites it normatively: YY/T 1994 on vascular interventional control systems takes its terms from here, as do YY/T 1941 for laparoscopic systems and the reliability and usability documents YY/T 1992 and YY/T 1993. Classification matters as much as vocabulary, because where a system falls in the scheme determines which particular requirements apply to it. For any manufacturer entering the Chinese market with a medical robot, this is the first document to read, and the one a submission has to align its language with.
Document preview — YY/T 1686-2024
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
Foreword
This document was issued on 29 September 2024 by the National Medical Products Administration and takes effect on 15 October 2025.
It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.
1 Scope
YY/T 1686 is the terminology and classification standard that the whole Chinese medical robotics framework rests on. It fixes the terms and definitions for medical electrical equipment employing robotic technology and sets out how such equipment is classified. Every one of the surgical robot standards cites it normatively: YY/T 1994 on vascular interventional control systems takes its terms from here, as do YY/T 1941 for laparoscopic systems and the reliability and usability documents YY/T 1992 and YY/T 1993. Classification matters as much as vocabulary, because where a system falls in the scheme determines which particular requirements apply to it. For any manufacturer entering the Chinese market with a medical robot, this is the first document to read, and the one a submission has to align its language with.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
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YY/T 1686-2024
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