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

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.