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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.

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.

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Document preview — YY/T 1686-2024

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

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

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Cited by

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