YY/T 1992-2025Robotically assisted surgery equipment - Summative usability test methods (English PDF)
采用机器人技术的辅助手术设备总结性可用性测试方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 30, 2025
Implementation date
November 1, 2026
Scope
YY/T 1992-2025 is the English-translated version of 采用机器人技术的辅助手术设备总结性可用性测试方法.
YY/T 1992 covers the human half of a surgical robot. It specifies the summative usability test methods for robotically assisted surgical equipment: the final validation study, run with representative users on the finished design, that demonstrates the interface can be used safely for its intended tasks. Summative testing is distinct from the formative work done during development, and Chinese reviewers treat the distinction seriously, which is why it has its own standard rather than a clause inside a general one. It was issued on the same day as YY/T 1993 on reliability verification and YY/T 1994 on vascular interventional control systems. For a manufacturer of surgical robots, this is the method the usability engineering file must follow for the Chinese market, and the reference a foreign vendor's IEC 62366 work will be read against.
Document preview — YY/T 1992-2025
National Standard of the People's Republic of China
- ICS
- 11.040.51
- Classification
- C43
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 30 October 2025 by the National Medical Products Administration and takes effect on 1 November 2026.
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.
It is classified under ICS 11.040.51, Chinese classification C43.
1 Scope
YY/T 1992 covers the human half of a surgical robot. It specifies the summative usability test methods for robotically assisted surgical equipment: the final validation study, run with representative users on the finished design, that demonstrates the interface can be used safely for its intended tasks. Summative testing is distinct from the formative work done during development, and Chinese reviewers treat the distinction seriously, which is why it has its own standard rather than a clause inside a general one. It was issued on the same day as YY/T 1993 on reliability verification and YY/T 1994 on vascular interventional control systems. For a manufacturer of surgical robots, this is the method the usability engineering file must follow for the Chinese market, and the reference a foreign vendor's IEC 62366 work will be read against.
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 — 55 pages — is available in the English PDF.
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