GB/T 19042.6-2023Evaluation and routine testing in medical imaging departments - Part 3-6: mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation imaging performance acceptance and constancy tests (English PDF)

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 3-6 of GB/T 19042 "Evaluation and Routine Testing of Medical Imaging Departments": GB/T 19042 has been released the following sections are included:

---Part 3-1: Imaging performance acceptance test of X-ray equipment for X-ray photography and fluoroscopy systems;

---Part 3-2: Mammography X-ray equipment imaging performance acceptance test;

---Part 3-3: Digital subtraction angiography (DSA) X-ray equipment imaging performance acceptance test;

---Part 3-4: Dental X-ray equipment imaging performance acceptance test;

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

---Part 3-6: Imaging performance acceptance and stability test of mammography X-ray equipment in breast tomosynthesis imaging mode:

This document is modified to adopt IEC 61223-3-6:2020 "Evaluation and routine testing of medical imaging departments Part 3-6: Acceptance and stabilization Experimental study on the imaging performance of mammography X-ray equipment in breast tomosynthesis imaging mode:

The technical differences between this document and IEC 61223-3-6:2020 and their reasons are as follows:

---Replaced IEC 60601-2-45 with GB 9706.245-2020 (see Chapter 3 and related provisions);

---Replaced IEC 61223-3-2:2007 with GB/T 19042.2 (see Chapter 3 and related provisions);

---Replaced IEC 61674:2012 with GB/T 19629 (see Chapter 3 and related provisions);

---Change "anode/filtration" to "target/filtration" (see 4.6:3, 10:1:3);

---Modify "When the results of the acceptance test meet the expected value, this value will be used as the benchmark value for subsequent stability tests:" in the Scope chapter to No: 5 Chapter, and add the voluntary verb "can" to express the degree of requirement (see 5.1):

The following editorial changes have been made to this document:

---In order to coordinate with the existing standards, the name of the standard is changed to "Evaluation and Routine Testing of Medical Imaging Departments Part 3-6: Breast Gland Transsection" Imaging performance acceptance and stability test of mammography X-ray equipment in layer synthesis imaging mode";

---Deleted the note on English language;

---Adjusted references;

--- Removed terminology index:

Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:

Introduction

GB/T 19042 "Evaluation and Routine Testing of Medical Imaging Departments" establishes a system of diagnostic X-ray equipment acceptance and stability test methods the system is divided into the following 6 parts:

---Part 3-1: Acceptance test of imaging performance of X-ray equipment for X-ray photography and fluoroscopy systems: The purpose is to give X-rays Test methods and requirements related to X-ray equipment for photography and fluoroscopy systems:

---Part 3-2: Mammography X-ray equipment imaging performance acceptance test: The purpose is to provide the cost of mammography X-ray equipment Like relevant test methods and requirements:

---Part 3-3: Digital subtraction angiography (DSA) X-ray equipment imaging performance acceptance test: The purpose is to give the number minus Test methods and requirements related to angiography X-ray equipment:

---Part 3-4: Dental X-ray equipment imaging performance acceptance test: The purpose is to give tests 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 radiographic computed tomography equipment:

---Part 3-6: Imaging performance acceptance and stability test of mammography X-ray equipment in breast tomosynthesis imaging mode: Head the aim is to provide the test methods and requirements related to mammography X-ray equipment imaging in breast tomosynthesis imaging mode:

This document establishes the imaging performance acceptance and stability testing of mammography X-ray equipment in breast tomosynthesis imaging mode method:

Evaluation and routine testing of medical imaging departments Part 3-6: Breast tomosynthesis imaging mode Mammography X-ray equipment imaging performance acceptance and Stability test

1 Scope

This document applies to the image quality and dose-related performance of mammography X-ray equipment in mammography tomosynthesis mode:

This document does not apply to the following situations:

---Operating modes other than the mammography tomosynthesis mode of mammography X-ray equipment;

---2D images generated from tomosynthesis images;

---Reconstructive tomography other than mammography tomosynthesis;

---CT scanning devices covered by GB/T 19042.5:

This document defines:

a) describe the basic parameters of accepted standards for tomosynthesis operating modes of mammography X-ray equipment in terms of image quality and dose;

b) Methods to detect whether the measured values related to these parameters comply with the specified deviation;

c) Frequency of stability testing when necessary:

This document is intended to be relevant to GB/T 19042.2 or equivalent specifications for 2D mammography related to mammography tomosynthesis operating modes:

Use together with the included acceptance criteria:

These methods are mainly based on non-intrusive measurements using appropriate test equipment and are carried out during or after installation: During the installation process , a signed declarative document containing the steps of this document can be used as part of the acceptance testing: Testing in high-level compliance requirements Take precedence over similar tests in lower-level compliance requirements:

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

GB 9706.245-2020 Medical electrical equipment Part 2-45: Mammography equipment and stereotaxic mammography equipment Special requirements for basic safety and basic performance of equipment (IEC 60601-2-45:2015, MOD) GB/T 19042.2 Evaluation and routine testing of medical imaging departments Part 3-2: Imaging performance test of mammography X-ray equipment Acceptance test (GB/T 19042.2-2005, IEC 61223-3-2:1996, IDT) GB/T 19629 Ionization chamber and/or semiconductor detector dosimeter used in X-ray diagnostic imaging of medical electrical equipment (GB/T 19629-2005,IEC 61674:1997,IDT)

3 Terms, definitions, symbols and abbreviations

3.1 Terms and definitions the following terms and definitions as defined in GB 9706.245-2020 and GB/T 19042.2 apply to this document: