YY/T 0910.1-2021Medical electrical equipment—Medical image display systems - Part 1: Evaluation methods (English PDF)

Foreword

YY/T 0910 "Medical Image Display System for Medical Electrical Equipment" includes the following parts.

--- Part 1: Evaluation methods;

--- Part 2: Acceptance and stability tests; This part is Part 1 of YY/T 0910.

This section is drafted in accordance with the rules given in GB/T 1.1-2009.

This part replaces YY/T 0910.1-2013 "Medical Image Display System for Medical Electrical Equipment Part 1: Evaluation Method", and Compared with YY/T 0910.1-2013, the main technical changes other than editorial changes are as follows.

--- Modified the scope (see Chapter 1, Chapter 1 of the.2013 edition);

--- Increased the alternative safety factor (see Table 1);

--- Modified the definition and interpretation of the physical parameter deltau'v' (see Table 1, Table 1 of the.2013 edition);

--- Modified the calculation formula of the maximum deviation of the brightness evaluation of multiple monitors (see 7.4.4, 7.4.4 of the.2013 edition);

--- Increased grayscale chromaticity evaluation (see 7.4.9).

Introduction

This section provides methods for evaluating image display systems for diagnostic imaging used in testing medical electrical equipment and medical electrical systems.

Two types of tests should be completed at the site of use or after installation. Acceptance test after installation of new video display system or on existing video display After the system is overhauled. Since the image display system will decay over time, the user conducts a stability test in a fixed period. to ensure that the performance of the system remains within the expected range of use.

This section describes different evaluation methods, but does not specify which method should be used for acceptance and/or stability testing.

Rather, the purpose of this section is to provide a reference for other standards or to provide a guide for each mode, or National authorities for evaluation methods in this standard provide a reference for defining limits and frequencies for acceptance and stability testing. See Appendix A A sample report of such a reference is given.

In order to maintain the consistency of IEC medical electrical equipment standards, IEC 61223-2-5 "Evaluation and Routine Tests of Medical Imaging Sectors No. Part 2-5.Image Display Device Stability Test" should be re-evaluated. This amendment was issued to introduce color measurement.

Since IEC 62563-1:2009 has been published, IEC 61223-2-5 "Evaluation and Routine Tests in the Medical Imaging Sector Part 2-5.Figures Like Display Device Stability Test" has been withdrawn.

1 Scope

This section specifies evaluation methods for testing medical imaging display systems.

The scope of this section refers to experiments that can be measured by visual judgment or using basic experimental equipment. with more advanced or Quantitative equipment tests are not within the scope of this section.

This section applies to medical image display systems that display image information in color or grayscale image display systems. This section applies to Diagnosis (interpretation of medical images to make a clinical diagnosis) or observation (observation of medical images for medical purposes rather than providing medical images Therefore, there are special requirements for image quality. Head-fixed image display system and image display system for determining positioning systems and the video display systems used to operate these systems are not included in the scope of this section. Handheld video display systems may require this Additional or modified versions of the steps described in subsections.

This section does not include requirements for defining acceptance testing and stability testing or requirements for the frequency of stability testing.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. finedterms)

ISO 11664-1:2007 Colorimetry Part 1: CIE Standard for Chromaticity Observation (Colorimetry-Part 1: CIE photometry)

3 Terms and Definitions, Symbols, Abbreviations