Valid

YY/T 1901-2023Requirements and test methods for orthopaedic surgical navigation equipment using robotic technology (English PDF)

采用机器人技术的骨科手术导航设备要求及试验方法

Preview PDF

This is a limited preview

Buy now to download the full PDF (26 pages)

Need quotation for your management?

Get a formal quotation for YY/T 1901-2023 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 5, 2023

Implementation date

September 15, 2024

Scope

YY/T 1901-2023 is the English-translated version of 采用机器人技术的骨科手术导航设备要求及试验方法.

YY/T 1901-2023 is the Chinese standard "Requirements and test methods for orthopaedic surgical navigation equipment using robotic technology".

Its scope clause reads: This document specifies the technical requirements for orthopedic surgery navigation equipment using robotic technology (hereinafter referred to as "orthopedic surgery navigation equipment").

Corresponding test methods are described. This document applies to navigation equipment for orthopedic surgeries (such as joint replacement surgery, spine surgery, trauma orthopedics, etc.). Its clauses include normative reference documents; terms and definitions.

Found what you need?

Document preview — YY/T 1901-2023

National Standard of the People's Republic of China

ICS: 11.040.51
Classification: C43

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative reference documents
3 Terms and Definitions
4 Requirements
4.1 General requirements
4.2 Performance of robotic arm positioning device
4.3 Tracking device performance
4.4 System performance
4.5 Installation repeatability
4.6 Protection function
4.7 Orthopedic power surgery equipment
4.8 Liquid cooling
4.9 Positioning accessory requirements
4.10 Software Requirements
5 Test method
5.1 General requirements
5.2 Performance of robotic arm positioning device
5.3 Tracking device performance
5.4 System performance
5.5 Installation repeatability
5.6 Protection functions
5.7 Orthopedic powered surgical equipment
5.8 Liquid cooling
5.9 Positioning accessory requirements
5.10 Software Requirements
Appendix A (informative) Orthopedic surgical navigation equipment and accessories
Appendix B (informative) Maximum end deflection test point 20 of the robot arm under payload
Appendix C (informative) System accuracy test phantom

1 Scope

This document specifies the technical requirements for orthopedic surgery navigation equipment using robotic technology (hereinafter referred to as "orthopedic surgery navigation equipment").

Corresponding test methods are described.

This document applies to navigation equipment for orthopedic surgeries (such as joint replacement surgery, spine surgery, trauma orthopedics, etc.).

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations

For undated reference documents, only the version corresponding to the date applies to this document; for undated referenced documents, the new version (including all amendments) applies to this document.

document.

GB/T 4340.1 Vickers hardness test of metallic materials Part 1.Test methods

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

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

YY/T 0752 Electric Bone Tissue Surgery Equipment

YY/T 1601 Ultrasonic bone tissue surgery equipment

YY/T 1712-2021 Auxiliary surgical equipment and auxiliary surgical systems using robotic technology

Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The terms and definitions defined in YY/T 1712-2021 and the following apply to this document.

3.1

It consists of a computer with relevant software, a tracking device, etc., which can track surgical instruments, robotic arm positioning devices, or treatment objects, and

Devices that provide real-time feedback through digital model visualization.

Note. For the schematic diagram, refer to A.1 in Appendix A.

[Source. ASTMF2554-18, 3.2.7, modified]

3.2 referenceelement

A tool applied to a surgical instrument, treatment object, positioning system, or other device to determine its position in three-dimensional space through a tracking device.

Intermittent position and posture.

Note. Commonly used reference devices include treatment object reference devices (reference devices that are applied to treatment objects or other devices and allow tracking of the object), positioning

Reference device (a reference device applied to a positioning system, imaging system or other device and allowing tracking of the object), tracking reference device (applied to the hand

A reference device on a surgical instrument or implant that allows tracking of the object), etc.

[Source. ASTMF2554-18, 3.2.8, modified] […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 26 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1694|YY/T 1711|YY/T 1537|YY/T 1903|YY/T 1905

How to Download YY/T 1901-2023

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.