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GB/T 19042.5-2022 English PDF

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GB/T 19042.5-2022: Evaluation and routine testing in medical imaging departments - Part 3-5: X-ray computed tomography equipment imaging performance acceptance test and constancy test
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GB/T 19042.5: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
GB/T 19042.5-2022English909 Add to Cart 7 days [Need to translate] Evaluation and routine testing in medical imaging departments - Part 3-5: X-ray computed tomography equipment imaging performance acceptance test and constancy test Valid GB/T 19042.5-2022
GB/T 19042.5-2006English1079 Add to Cart 5 days [Need to translate] Evaluation and routine testing in medical imaging departments -- Part 3-5: Acceptance tests -- Imaging performances of computed tomography X-ray equipment Obsolete GB/T 19042.5-2006

PDF similar to GB/T 19042.5-2022


Standard similar to GB/T 19042.5-2022

GB/T 13797   GB/T 20013.3   GB 9706.5   GB/T 19042.2   GB/T 19042.6   GB/T 18987   

Basic data

Standard ID GB/T 19042.5-2022 (GB/T19042.5-2022)
Description (Translated English) Evaluation and routine testing in medical imaging departments - Part 3-5: X-ray computed tomography equipment imaging performance acceptance test and constancy test
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 50,584
Date of Issue 2022-10-14
Date of Implementation 2023-11-01
Older Standard (superseded by this standard) GB/T 19042.5-2006, GB/T 17006.11-2015
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 19042.5-2022: Evaluation and routine testing in medical imaging departments - Part 3-5: X-ray computed tomography equipment imaging performance acceptance test and constancy test


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Evaluation and routine testing in medical imaging departments -- Part 3-5.X-ray computed tomography equipment imaging performance acceptance test and constancy test ICS 11.040.50 CCSC43 National Standards of People's Republic of China Replacing GB/T 17006.11-2015, GB/T 19042.5-2006 Evaluation and Routine Testing in the Medical Imaging Department Part 3-5.X-ray computed tomography equipment Imaging performance acceptance test and stability test 2022-10-12 Released 2023-11-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface III Introduction V 1 Scope and Purpose 1 2 Normative references 1 3 Terms and Definitions 1 4 Overview of Acceptance Test and Stability Test 7 4.1 General situations to be considered in the test procedure 7 4.2 Test files and data in accompanying documents 9 4.3 Scope of the test 10 4.4 Considerations for Selection of Acceptance Tests and Stability Tests 10 4.5 Measuring equipment 11 4.6 Actions to be taken after major maintenance11 4.7 Establishment of reference values 11 4.8 Frequency of stability tests 11 5 Test methods for CT scanning devices 11 5.1 Patient support positioning 11 5.2 Patient positioning accuracy 13 5.3 Reconstructed slice thickness 14 5.4 Dosage 16 5.5 Average CT, Noise Amplitude, and Uniformity 18 5.6 Spatial resolution (high contrast) 23 5.7 Automatic Exposure Control (AEC) 24 5.8 Low-contrast resolution and low-contrast detection capability 25 Appendix A (informative) Correspondence between this document and other standards and regulations26 APPENDIX B (INFORMATIVE) GUIDELINES FOR ACTIONS TO TAKE 28 Appendix C (Informative) Automatic Exposure Control (AEC) 30 Appendix D (informative) Summary of criteria and frequencies for acceptance and stability tests 32 Appendix E (Informative) Visual Methods for Low Contrast Resolution 35 Appendix F (Informative) Dose Distribution 36 Appendix G (Informative) Gantry Tilt Accuracy 37 Appendix H (informative) z-direction spatial resolution 39 Appendix I (informative) Helical reconstruction slice thickness 40 Appendix J (informative) Overview of the criteria for acceptance testing and stability testing 41 Reference 42

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 of Standardization Documents" drafted. This document is part 3-5 of GB/T 19042 "Evaluation and Routine Tests in Medical Imaging Departments". GB/T 19042 has been released The following parts. --- Part 3-1.Imaging performance acceptance test of X-ray equipment for X-ray photography and fluoroscopy systems (GB/T 19042.1); --- Part 3-2.Imaging performance acceptance test of mammography X-ray equipment (GB/T 19042.2); --- Part 3-3.Digital Subtraction Angiography (DSA) X-ray Equipment Imaging Performance Acceptance Test (GB/T 19042.3); --- Part 3-4.Imaging performance acceptance test of dental X-ray equipment (GB/T 19042.4); --- Part 3-5.X-ray computed tomography equipment imaging performance acceptance test and stability test (GB/T 19042.5). This document replaces GB/T 19042.5-2006 "Evaluation and Routine Tests of Medical Imaging Departments - Part 3-5.X-ray Computers Imaging Performance Acceptance Test of Tomography Equipment" and GB/T 17006.11-2015 "Evaluation and Routine Test of Medical Imaging Department No. 2- Part 6.Imaging performance stability test of X-ray computed tomography equipment. This document will GB/T 19042.5-2006 and GB/T 17006.11-2015 is integrated together, compared with GB/T 19042.5-2006 and GB/T 17006.11-2015, except for structural adjustment In addition to the adjustment and editorial changes, the main technical changes are as follows. a) The terms and definitions have been changed to maintain consistency with the latest version of normative references (see Chapter 3, GB/T 19042.5-2006 Chapter 3, and Chapter 3 of GB/T 17006.11-2015); b) Added separate requirements for test devices, corresponding requirements for accompanying documents, and selection of acceptance tests and stability tests consideration (see 4.1.5, 4.2, 4.4); c) Added measures to be taken after major maintenance (see 4.6); d) The requirement of "reconstruction slice thickness" has been changed and replaced by "volume slice thickness" (see 5.3, 5.3 of GB/T 19042.5-2006, 5.3 of GB/T 17006.11-2015); e) Changed the judgment criteria of some acceptance tests (see 5.3.2.5, 5.4.5, 5.5.5, see 5.3.1.5, 5.3.1.5, 5.3.1.5 of GB/T 19042.5-2006 5.4.5, 5.5.5); f) Changed the judgment criteria of some stability tests (see 5.4.6.1, 5.5.6.1, see 5.4.5, 5.4.5, 5.4.5, GB/T 17006.11-2015). 5.5.5, 5.6.5); g) The corresponding requirements for typical children's head/body operating conditions have been added, and the relevant requirements for typical adult head/body operating conditions have been changed. requirements (see 5.4, 5.5, 5.4, 5.5 of GB/T 19042.5-2006; 5.3, 5.5 of GB/T 17006.11-2015); h) Added relevant content about the use of filtered back projection (see 5.5.4.3); i) Added requirements for image quality and artifact inspection (see 5.5.4.4); j) Added the relevant content of automatic exposure control (see 5.7); k) Added content related to low-contrast resolution and low-contrast detection capability (see 5.8). This document is modified to adopt IEC 61223-3-5.2019 "Evaluation and Routine Tests in Medical Imaging Sectors Part 3-5.Acceptance Tests and Stability test imaging performance of X-ray computed tomography equipment. Compared with IEC 61223-3-5.2019, this document has made the following structural adjustments. --- Adjust Appendix A of IEC 61223-3-5.2019 to Appendix E; adjust Appendix B of IEC 61223-3-5.2019 to Appendix F; Adjust Appendix C of IEC 61223-3-5.2019 to Appendix G; Adjust Appendix D of IEC 61223-3-5.2019 to Appendix Record H; Adjust Annex E of IEC 61223-3-5.2019 to Annex I; Adjust Annex F of IEC 61223-3-5.2019 to Appendix B; adjust Appendix G of IEC 61223-3-5.2019 to Appendix C; adjust Appendix H of IEC 61223-3-5.2019 Reorganized as Appendix A; adjusted Appendix I of IEC 61223-3-5.2019 to Appendix J; adjusted Appendix J of IEC 61223-3-5.2019 Adjusted to Appendix D. The technical differences between this document and IEC 61223-3-5.2019 and their reasons are as follows. --- Replaced IEC 60601-1.2012 (see 4.2) with the normatively cited GB 9706.1-2020, consistency between the two documents The degree of modification is to adapt to the technical conditions of our country and increase the operability; --- Replaced IEC 60601-2-44.2016 with the normatively cited GB 9706.244-2020 (see Chapter 1, Chapter 3, 5.4.1~ 5.4.3), the degree of consistency between the two documents is to be modified to adapt to the technical conditions of our country and increase the operability; --- Added relevant requirements for CT applications or radiation detectors that meet other regulatory requirements (see 5.4.2); --- Changed the content of the description of the test in the first column 5.4.3 of Table A.1 to make it consistent with the text (see Table A.1); --- Changed the description of the stability test corresponding to 5.5 in Table D.1 to make it consistent with the text (see Table D.1). The following editorial changes have been made to this document. --- In order to harmonize with existing standards, the name of the standard was changed to "Evaluation and Routine Tests in Medical Imaging Departments Part 3-5.X-ray Computed Tomography Equipment Imaging Performance Acceptance Test and Stability Test"; --- Deleted "Note" in Chapter 1, and "Note 4" and "Note 5" of 5.4.3; --- Deleted the index of international standards, adjusted the index number of other references; --- Modified an obviously wrong chapter number, and changed C.4 to C.3.4. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee of Medical Electrical Appliances (SAC/TC10). This document is drafted by. Shanghai Siemens Medical Devices Co., Ltd., Liaoning Provincial Institute of Medical Device Inspection and Testing, Hangwei General Electric Medical Systems Co., Ltd., Neusoft Medical Systems Co., Ltd., Philips Medical (Suzhou) Co., Ltd., Shanghai United Imaging Medical Technology Co., Ltd. Company, Mingfeng Medical System Co., Ltd., Shenzhen Anke High-tech Co., Ltd., Kuanteng (Beijing) Medical Equipment Co., Ltd., Langfang City Mocot Medical Technology Co., Ltd. The main drafters of this document. Tian Yi, Sun Zhiyong, Ye Shuoqi, Wei Dong, Li Xiang, Jiang Nan, Zhou Pei, Liu Zhibo, Wang Bin, Xu Dan, Liang Tiecheng, Xing Zhanfeng, Zhao Bingjie, Jin Yubo, Fan Bo, Zeng Kai, Xu Jialin. The previous versions of the documents replaced by this document are as follows. ---GB/T 17006.11, first released in.1997, first revised in.2015; ---GB/T 19042.5, first released in.2006.

Introduction

GB/T 19042 "Evaluation and Routine Tests of Medical Imaging Departments" establishes information on image quality of X-ray imaging equipment, patient positioning and And imaging dose-related acceptance test and stability test method system, and give the relevant requirements. It is divided into the following parts. --- Part 3-1.Imaging performance acceptance test of X-ray equipment for X-ray photography and fluoroscopy systems. X-ray photography and Test methods and requirements related to X-ray equipment for fluoroscopy systems (GB/T 19042.1). --- Part 3-2.Imaging performance acceptance test of mammography X-ray equipment. Mammography X-ray equipment imaging correlation is given test methods and requirements (GB/T 19042.2). --- Part 3-3.Acceptance test for imaging performance of digital subtraction angiography (DSA) X-ray equipment. digital subtraction vessels are given Test methods and requirements related to contrast X-ray equipment (GB/T 19042.3). --- Part 3-4.Imaging performance acceptance test of dental X-ray equipment. Test methods related to dental X-ray equipment and requirements (GB/T 19042.4). --- Part 3-5.X-ray computed tomography equipment imaging performance acceptance test and stability test. X-ray meter is given Test methods and requirements related to computer tomography equipment (GB/T 19042.5). After installation of new X-ray computed tomography equipment, or major modifications to existing X-ray computed tomography equipment In order to easily verify safety and performance standards, regulations, and contractual terms that affect image quality, patient dose, and positioning after the operation, Requirements for the experimental methods and biases for performing acceptance tests are provided. In addition, the method of stability test, deviation requirements and test frequency are also proposed. rate and provides guidance on actions to be taken when requirements are exceeded. Certain terms or statements in this document require additional information. This supplementary information is described in the appendix. Evaluation and Routine Testing in the Medical Imaging Department Part 3-5.X-ray computed tomography equipment Imaging performance acceptance test and stability test

1 Scope and Purpose

This document and GB 9706.244-2020. --- Established the basic parameters describing the imaging performance of CT scanning devices, including image quality, radiation output and patient positioning. experimental For a list of parameters see 4.3; --- describes the test method for the basic parameters; and --- Specifies the error range of the specified parameters given in the accompanying documents to evaluate whether the requirements are met. GB 9706.244-2020 and the test methods described in this document rely on the use of appropriate test equipment, during installation or during installation. After the machine, non-invasive measurements were carried out. Steps covered in the installation process, signed declarations can be part of the acceptance test report. This document applies to CT scanning devices that comply with GB 9706.244-2020. This document applies to acceptance tests and stability tests of CT scanning devices. The purpose of the acceptance test is to verify the installation or major maintenance warranty. Whether maintenance affects image quality, radiation output, and patient positioning meet specifications. Stability testing is carried out to ensure that the functional conforms to established guidelines and enables early identification of changes in performance of device components and verification of impact on image quality, radiation output, and patient outcomes bits conform to the specification. This document also contains requirements for accompanying documents related to acceptance testing and stability testing of CT scanning devices. This document does not apply to the following situations. --- aspects of mechanical and electrical related safety; and --- Mechanical, electrical and software performance, unless it is necessary to perform acceptance tests and stability tests, and will directly affect the diagram Image quality, radiation output and patient positioning.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB 9706.1-2020 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance (IEC 60601-1. 2012, MOD) GB 9706.244-2020 Medical Electrical Equipment Part 2-44.Basic Safety and Basic X-ray Computed Tomography Equipment Specific requirements for performance safety (IEC 60601-2-44.2016, MOD) GB/T 19629 Ionization chamber and/or semiconductor detector dosimeters used in X-ray diagnostic imaging of medical electrical equipment (IEC 61674.1997, IDT) finedterms)

3 Terms and Definitions

Terms and definitions defined in GB 9706.244-2020 and IEC TR60788 and the following terms and definitions apply to this document.

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