GB/T 19042.2-2025Evaluation and routine testing in medical imaging departments - Part 3-2: Mammographic X-ray equipment imaging performance acceptance tests (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document is part 3-2 of GB/T 19042 Evaluation and routine testing of medical imaging departments. GB/T 19042 has been published.

The following parts.

--- Part 3-1.Acceptance tests for imaging performance of X-ray equipment for X-ray radiography and fluoroscopy systems;

--- Part 3-2.Acceptance test for imaging performance of mammographic X-ray equipment;

--- Part 3-3.Acceptance test for imaging performance of X-ray equipment for digital subtraction angiography (DSA);

--- Part 3-4.Acceptance test for imaging performance of dental X-ray equipment;

--- Part 3-5.X-ray computed tomography equipment imaging performance acceptance test and stability test;

--- Part 3-6.Acceptance and stability testing of imaging performance of mammographic X-ray equipment in breast tomosynthesis imaging mode.

This document replaces GB/T 19042.2-2005 "Evaluation and routine testing of medical imaging departments Part 3-2.Mammography X-ray Compared with GB/T 19042.2-2005, in addition to structural adjustments and editorial changes, the main technical changes are as follows.

--- Changed the terms and definitions (see Chapter 3, Chapter 3 of the 2005 edition);

--- Added general rules for acceptance tests (see Chapter 4);

--- Changed the test methods for mammary X-ray equipment (see 5.1 to 5.11, 5.1 to 5.11 of the 2005 edition);

--- Added requirements for digital systems (see 5.12, 5.13.2, 5.14.2, 5.15.2, 5.16);

--- Added requirements for screen-film systems (see 5.13.1, 5.14.1, 5.15.1, 5.16);

--- Added the requirements for the reference value of the stability test (see Chapter 6);

--- Changed the test report and declaration of conformity (see Chapter 7, Chapter 6 of the 2005 edition).

This document modifies the IEC 61223-3-2:2007 "Evaluation and routine testing acceptance tests for medical imaging departments Part 3-2.

Imaging Performance of Mammographic X-ray Equipment.

This document has the following structural adjustments compared to IEC 61223-3-2:2007.

--- Adjust Table 1 of IEC 61223-3-2:2007 to 3.2 and add abbreviations (see 3.2);

--- Modify Table 2 of IEC 61223-3-2:2007 to Table 1 (see 5.3.2);

--- Adjust Appendix A of IEC 61223-3-2:2007 to Appendix C; Adjust Appendix B of IEC 61223-3-2:2007 to Appendix D; Adjust Appendix C of IEC 61223-3-2:2007 to Appendix A; Adjust Appendix D of IEC 61223-3-2:2007 to Appendix B. Adjust Appendix E of IEC 61223-3-2:2007 to Appendix G; Adjust Appendix F of IEC 61223-3-2:2007 to to Appendix J; to adjust Appendix G of IEC 61223-3-2:2007 to Appendix K; to adjust Appendix H of IEC 61223-3-2:2007 to Appendix Adjusted to Appendix E; Adjusted Appendix I of IEC 61223-3-2:2007 to Appendix F; Adjusted Appendix J is adjusted to Appendix I; Appendix K of IEC 61223-3-2:2007 is adjusted to Appendix H.

The technical differences between this document and IEC 61223-3-2:2007 and their reasons are as follows.

--- The normative reference GB 9706.1 replaces IEC 60601-1 (see 4.3) to adapt to my country's technical conditions and increase operability Sexuality;

--- Replaced IEC 60601-2-45 (see 4.6.4, 5.3.1, 5.5.1) with the normative reference GB 9706.245 to adapt to my country's technical standards.

Technical conditions, increase operability;

--- Replaced IEC 61674 (see 4.6.5) with the normative reference GB/T 19629 to increase operability;

--- Replaced IEC 61223-2-1 (see 4.2) with the normative reference GB/T 17006.2 to increase operability;

--- Replaced IEC 60336 (see 5.4.1, 5.4.2) with the normative reference YY/T 0063 to adapt to my country's technical conditions, and added operability;

--- Changed the terminology (see 3.1) to coordinate with Chinese standards;

--- Adjust the note in 4.1.2 to the main text (see 4.1.2) to adapt to my country's technical conditions.

The following editorial changes have been made to this document.

--- To coordinate with the Chinese standard, the name of the standard was changed to "Evaluation and routine testing of medical imaging departments Part 3-2.Mammography "Acceptance test of imaging performance of X-ray equipment";

--- Added notes (see Chapter 1, 3.1.1, 5.7.1.2, 5.7.1.3.3, Appendix G);

--- Changed the item number in "Requirement Level" (see 4.1);

--- Deleted the note to 5.13.1.1 and the note after the second paragraph of 5.13.2.1 in IEC 61223-3-2:2007;

--- Removed term index.

Introduction

GB/T 19042 "Evaluation and routine testing of medical imaging departments" established a system of acceptance and stability test methods for diagnostic X-ray equipment.

The system is divided into six parts.

--- Part 3-1.Acceptance test for imaging performance of X-ray equipment for X-ray photography and fluoroscopy systems. The purpose is to give the X-ray Test methods and requirements related to X-ray equipment for use in radiography and fluoroscopy systems.

--- Part 3-2.Acceptance test for imaging performance of mammography X-ray equipment. The purpose is to give the acceptance test for imaging performance of mammography X-ray equipment.

Like relevant test methods and requirements.

--- Part 3-3.Acceptance test for imaging performance of X-ray equipment for digital subtraction angiography (DSA).

Test methods and requirements related to angiographic X-ray equipment.

--- Part 3-4.Acceptance test for dental X-ray equipment imaging performance. The purpose is to give the test related to dental X-ray equipment Methods and requirements.

--- Part 3-5.X-ray computed tomography equipment imaging performance acceptance test and stability test. The purpose is to give X Test methods and requirements related to CT equipment.

--- Part 3-6.Acceptance and stability test methods for imaging performance of mammographic X-ray equipment in breast tomosynthesis imaging mode.

The purpose is to provide test methods and requirements related to mammographic X-ray equipment imaging in breast tomosynthesis mode.

This document establishes the requirements for mammographic X-ray equipment and mammographic stereotactic imaging using film, IP panels, integrated digital X-ray image receptors.

Test method for acceptance test of body positioning devices.

Evaluation and routine testing in medical imaging departments Part 3-2.Mammographic X-ray equipment Imaging performance acceptance test

1 Scope

This document is applicable to the effectiveness evaluation of mammography X-ray equipment in terms of image quality and dose, and also covers equipment safety aspects.

content.

This document applies to mammography X-ray equipment (hereinafter referred to as "mammography X-ray equipment") and mammography stereotactic devices.

When the X-ray image receptor is not part of the mammography equipment, the tests described in this document shall ensure that the X-ray image receptor is not part of the mammography equipment.

The quality and performance of X-ray image receptors, including X-ray photographic film (hereinafter referred to as "film"), intensifying screens, X-ray photographic cassettes (hereinafter referred to as "dark box"), storage phosphor plate (hereinafter referred to as "IP plate") and auxiliary equipment, such as film processor or storage phosphor plate reading device (hereinafter referred to as "IP plate") (abbreviated as "CR"), image display devices and hard copy cameras.

Note. For the description of IP board and CR, see 3.2 and 3.1 of YY/T 0794-2022.

For tests on cassettes and intensifying screens in this document, see ISO 4090.For tests on sensitivity and contrast of screen-film image receptors, see ISO 4090.

ISO 9236-3.

The measurements described in this document provide data for the calculation of mean glandular doses.

When the result of the acceptance test meets the expected value, this value can be used as the benchmark value for subsequent stability tests.

This document defines.

a) basic parameters of the performance of the above-mentioned mammography equipment in terms of image quality and dose; and

b) Methods for checking whether the measurement results related to these parameters comply with the specified deviations.

These methods are mainly based on non-intrusive measurements using appropriate test equipment and are performed during or after installation.

A signed declarative document containing the steps of this document can be used as part of the acceptance test.

Take precedence over similar tests in lower-level conformance requirements. This principle is described in 4.1.

This document does not specify limits or deviations for the parameters to be measured.

Difficulties may arise in identifying the responsible party for the acceptance test when changes are made to the screen-film combination, film developer, or CR.

There are a number of reasons for this. First, the image receptor manufacturer and the X-ray equipment manufacturer may be different. Second, the image receptor manufacturer may be different.

Changes in receivers or film processing chemicals may alter system performance. When these situations occur, it is important to perform acceptance testing.

When changes occur that may alter system performance, the system integrator (i.e., the party responsible for handling the changes) discusses the changes with the X-ray equipment manufacturer.

It is important to understand the impact of variability so that the latter can adjust the imaging system if necessary.

Acceptance testing of mammography equipment requires general skills in medical physics. The execution of the tests is governed by relevant regulations (e.g.

Decisions (including agreements, regulations, and laws).

2 Normative references

The contents of the following documents constitute the 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 9706.1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (GB 9706.1-2020, IEC 60601-1:2012, MOD)