GB/T 19042.6-2023 English PDF

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GB/T 19042.6-2023: Evaluation 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
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Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 19042.6-2023	809	Add to Cart	6 days	Evaluation 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	Valid

Similar standards

GB/T 13797   GB/T 20013.3   GB 9706.5   GB/T 19042.2   GB/T 19042.5   GB/T 18987   

Basic data

Standard ID: GB/T 19042.6-2023 (GB/T19042.6-2023)
Description (Translated English): Evaluation 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
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.50
Word Count Estimation: 40,483
Date of Issue: 2023-11-27
Date of Implementation: 2024-12-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 19042.6-2023: Evaluation 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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11:040:50 CCSC43 National Standards of People's Republic of China 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 constancytests Published on 2023-11-27 and implemented on 2024-12-01 State Administration for Market Regulation Released by the National Standardization Administration Committee

Table of contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms, definitions, symbols and abbreviations 1 3:1 Terms and definitions 1 3:2 Symbols and abbreviations 4 4 General principles for acceptance testing 4 4:1 Requirements Level 4 4:2 Test procedure 4 4:3 Documents and data required for testing 5 4:4 Test conditions 5 4:5 Test range 5 4:6 Test equipment 6 4:7 Evaluation of test results 7 5 General rules for stability testing 7 5:1 Establishment of benchmark values 7 5:2 Frequency of stability tests 7 6 Breast tomosynthesis imaging equipment trial overview 7 7 Breast Tomosynthesis Imaging Equipment Test Checklist and Initial Testing 9 7:1 Requirements 9 7:2 Test methods 9 7:3 Stability test 9 7:4 Taking measures 9 8 Alignment and alignment check 9 8:1 Requirements 9 8:2 Test methods 9 8:3 Stability test 10 8:4 Test equipment10 8:5 Take measures10 9 Automatic exposure control (AEC) system 10 9:1 General 10 9:2 Short-term repeatability10 9:3 Long-term repeatability11 9:4 Automatic exposure control (AEC) performance12 10 Image receiver 14 10:1 Response function 14 10:2 Detector dead pixel 15 10:3 Uncorrected detector dead pixels16 10:4 System projection MTF 17 11 Reconstructed image quality 18 11:1 Model test 18 11:2 z-axis resolution (artifact diffusion function) 18 12 missing tissue 20 12:1 General 20 12:2 Tissue loss on the chest wall side of tomographic reconstruction images 21 12:3 Tissue loss at the top and bottom of tomographic reconstruction 21 13 Artifacts in tomographic data 23 13:1 Overview 23 13:2 Artifact assessment 23 13:3 Geometric distortion 23 14 Dose in digital breast tomography 25 14:1 Requirement 25 14:2 Test method 25 14:3 Stability test 26 14:4 Test equipment 27 14:5 Taking measures 27 Appendix A (informative) Digital mammography tomosynthesis dose calculation table 28 Appendix B (Normative) Operation Guide 31 B:1 First non-compliance with test determination criteria31 B:2 Repeated non-compliance with determination criteria31 B:3 Minor non-compliance with determination criteria31 B:4 There are historical records that repeatedly fail to meet the determined criteria31 B:5 Serious non-compliance with determination criteria31 B:6 Measures not included in B:1~B:531 Appendix C (informative) Image quality assessment 32 Appendix D (informative) Artifact 33 Reference 34

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: This document is proposed by the State Food and Drug Administration and is under the jurisdiction of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10): This document was drafted by: Liaoning Provincial Medical Device Inspection and Testing Institute, Shenzhen Sennuo Medical Equipment Co:, Ltd:, Daying Medical (Zhongshan) Co:, Ltd:, Beijing Haoluojie Technology Co:, Ltd:, Shanghai Aohua Endoscopy Co:, Ltd:, and Fujifilm (China) Investment Co:, Ltd: The main drafters of this document: Guo Baijun, Jin Yubo, Sun Zhiyong, Li Wenyu, Wu Tao, Shao Changyun, Qian Chunjian, Meng Zhaoyang, Tang Zhiwei:

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: ......

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