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YY/T 1993-2025Reliability testing methods for robotically assisted surgical equipment (English PDF)

采用机器人技术的辅助手术设备可靠性验证方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

October 30, 2025

Implementation date

November 1, 2026

Scope

YY/T 1993-2025 is the English-translated version of 采用机器人技术的辅助手术设备可靠性验证方法.

Reliability here is not a single test but a route: how the verification is planned, what evidence counts, and which methods are appropriate for equipment whose failure happens in an operating theatre.

It sits alongside the usability standard YY/T 1992 and the vascular interventional control system standard YY/T 1994, all issued on the same day, which together form the current Chinese framework for surgical robotics.

For a manufacturer preparing an NMPA submission, this is the document the reliability section of the technical file has to answer to.

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Document preview — YY/T 1993-2025

National Standard of the People's Republic of China

ICS: 11.040.51
Classification: C39

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

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 C39.

1 Scope

YY/T 1993 answers a question every surgical robot maker eventually faces in China: how do you prove the machine keeps working. It describes the pathways and the methods for carrying out reliability verification on robotically assisted surgical equipment, referred to throughout by the abbreviation RASE. Reliability here is not a single test but a route: how the verification is planned, what evidence counts, and which methods are appropriate for equipment whose failure happens in an operating theatre. It sits alongside the usability standard YY/T 1992 and the vascular interventional control system standard YY/T 1994, all issued on the same day, which together form the current Chinese framework for surgical robotics. For a manufacturer preparing an NMPA submission, this is the document the reliability section of the technical file has to answer to.

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 — 47 pages — is available in the English PDF.

Referenced standards

Cited by

Similar standards

YY/T 1933|YY/T 1712|YY/T 1519|YY/T 1994

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