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YY/T 1941-2024Robotically-assisted laparoscopic surgical system (English PDF)

采用机器人技术的腹腔内窥镜手术系统

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 29, 2024

Implementation date

October 15, 2025

Scope

YY/T 1941-2024 is the English-translated version of 采用机器人技术的腹腔内窥镜手术系统.

YY/T 1941-2024 is the Chinese standard "Robotically-assisted laparoscopic surgical system". Its scope clause reads: This document specifies the technical requirements for laparoscopic surgical systems using robotic technology and describes the corresponding test methods.

This document applies to laparoscopic surgical systems using robotics technology, as well as machines connected through interaction conditions and interface conditions.

Robotic surgical instruments. This document does not apply to laparoscopic single-port surgical systems. Its clauses include terms and definitions.

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Document preview — YY/T 1941-2024

National Standard of the People's Republic of China

ICS: 11.040
Classification: C43

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirement
4.1 Manual Controller Performance
4.2 Instrument Manipulator Performance
4.3 System Operation Performance
4.4 Security protection function
4.5 Robotic surgical instruments
4.6 Software
5 Test methods
5.1 Manual Controller Performance
5.2 Instrument Manipulator Performance
5.3 System Operation Performance
5.4 Security protection function
5.5 Robotic surgical instruments
5.6 Software
References

1 Scope

This document specifies the technical requirements for laparoscopic surgical systems using robotic technology and describes the corresponding test methods.

This document applies to laparoscopic surgical systems using robotics technology, as well as machines connected through interaction conditions and interface conditions.

Robotic surgical instruments.

This document does not apply to laparoscopic single-port surgical systems.

2 Normative references

The contents of the following documents constitute 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/T 4340.1 Vickers hardness test for metallic materials Part 1.Test method

GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance

GB/T 14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods

YY/T 0043 Medical Suture Needle

YY/T 0149 Test method for corrosion resistance of stainless steel medical devices

YY 0167 Non-absorbable surgical suture

YY/T 1686 Terminology, definitions and classification of medical electrical equipment using robotic technology

YY/T 1712 Assisted surgical equipment and assisted surgical systems using robotic technology

YY 9706.277 Medical electrical equipment Part 2-77.Basic safety and basic requirements for surgical assistance equipment using robotic technology

Performance-specific requirements

Pharmacopoeia of the People's Republic of China 2020 Edition Volume IV

3 Terms and definitions

The terms and definitions defined in GB 9706.1, YY/T 1712, YY/T 1686, YY 9706.277 and the following apply to this document.

3.1

A laparoscopic surgical device/system using robotic technology, which is expected to control robotic surgical instruments through master-slave operation and/or endoscope, while viewing through the endoscope.

Note. RALS usually includes a doctor's console, a patient surgical platform, an image processing platform, a three-dimensional laparoscopic endoscope (abbreviated as endoscope), and a robotic surgical instrument.

Machinery, etc.

3.2

A mechanical structure used to capture or record operator's hand movements.

Note. Also called the master hand.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1694|YY/T 1711|YY/T 1537|YY/T 1625|YY/T 1944

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