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YY/T 0910.2-2025Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays (English PDF)

医用电气设备 医学影像显示系统 第2部分:医学影像显示系统的验收和稳定性试验

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Issued by

National Medical Products Administration

Level / Type

National · Recommended

Issue date

October 30, 2025

Implementation date

November 1, 2026

Scope

YY/T 0910.2-2025 is the English-translated version of 医用电气设备 医学影像显示系统 第2部分:医学影像显示系统的验收和稳定性试验.

YY/T 0910.2-2025 — This document specifies the guidelines and testing frequency for acceptance and stability tests. The evaluation methods are specified in IEC 62563-1.

This document covers practical tests that can be visually evaluated or experimentally measured using basic testing tools. This document applies to medical imaging display systems that can display images in grayscale values on color and grayscale image display systems.

Monochrome image information. This document does not apply to information displays, nor to displays used solely for controlling medical information technology parameters.

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Document preview — YY/T 0910.2-2025

National Standard of the People's Republic of China

ICS
11.040.50
Classification
C 43

Issued by: National Medical Products Administration

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 Normative References
  • 3 Terms and Definitions, Symbols and Abbreviations
  • 4 General Rules
  • 5 Categories
  • 6 Acceptance Test
  • 6.1 General Requirements
  • 6.2 Timing of the Test
  • 6.3 Evaluation Items and Criteria for Acceptance Testing
  • 6.4 Acceptance Test Results
  • 7 Stability test 8.
  • 7.1 General Requirements
  • 7.2 Frequency of stability tests
  • 7.3 Evaluation Items and Criteria
  • 7.4 Stability Test Results
  • Appendix A (Informative) Sample Test Report
  • A.1 Overview

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document is Part 2 of YY/T 0910 "Medical Electrical Equipment for Medical Imaging Display Systems". YY/T 0910 has been published...

Part 2.

---Part 1: Evaluation Methods;

---Part 2: Acceptance and stability testing of medical imaging display systems.

This document is equivalent to IEC 62563-2:2021 "Medical electrical equipment - Medical imaging display systems - Part 2: Medical imaging display".

System acceptance and stability testing.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document was prepared by the Medical X-ray Equipment and Instruments Subcommittee of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10/SC1) is under the jurisdiction of the State.

Introduction

Acceptance and stability tests are conducted on-site at the installation facility. This applies when installing a new image display system or undertaking major modifications to an existing one.

After modifications, acceptance testing will be conducted. Because the image display system will degrade over time, stability tests must be performed periodically.

This is done through testing to ensure that its performance is maintained.

YY/T 0910 "Medical Electrical Equipment for Medical Imaging Display Systems" is proposed to be divided into 3 parts.

---Part 1: Evaluation Methods;

---Part 2: Acceptance and Stability Testing;

---Part 3: Evaluation Methods for Color Displays Medical electrical equipment and medical imaging display systems Part 2: Acceptance of Medical Imaging Display Systems Stability test

1 Scope

This document specifies the guidelines and testing frequency for acceptance and stability tests. The evaluation methods are specified in IEC 62563-1.

This document covers practical tests that can be visually evaluated or experimentally measured using basic testing tools.

This document applies to medical imaging display systems that can display images in grayscale values on color and grayscale image display systems.

Monochrome image information.

This document does not apply to information displays, nor to displays used solely for controlling medical information technology parameters.

2 Normative references

The contents of the following documents, through normative references within the text, constitute indispensable clauses of this document. Among them, dated citations...

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

document.

YY/T 0910.1-2021 Medical electrical equipment for medical imaging display systems – Part 1: Evaluation methods (IEC 62563-1) 2016, IDT) (defined terms)

3 Terms and definitions, symbols and abbreviations

3.1 Terms and Definitions

The terms and definitions defined in IEC TR60788:2004 and YY/T 0910.1-2021, as well as the following terms and definitions, apply to this document.

3.1.1

Acceptance test

Tests conducted after equipment installation or after significant modifications to existing equipment are designed to confirm compliance with the manufacturer's specifications or requirements.

3.1.2

stability test

Tests conducted to confirm that the performance of the equipment meets established criteria and to identify changes in the characteristics of equipment components as early as possible.

3.1.3

luminance stabilizer the embedded function of the image display system, which uses sensors to detect light sources caused by the image display system itself or its environment.

It detects brightness deviations (e.g., at startup, degradation over time, or temperature changes) and automatically adjusts the light source to stabilize display brightness.

3.1.4

Criteria

Acceptable deviations or limits in the test results of acceptance or stability tests are used to indicate whether the test items are qualified.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Referenced standards

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