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 (English Version)

Standard No.

GB/T 19042.5-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 19042.5-2022

Replace

GB/T 19042.5-2006 GB/T 17006.11-2015

Scope

This document and GB9706.244-2020: 　——Establishes the basic parameters describing the imaging performance of CT scanning devices, including image quality, radiation output and patient positioning. See 4.3 for a list of parameters to be tested; 　——describes the test method for the basic parameters; and — specifies the evaluation of compliance with the requirements based on the error range of the specified parameters given in the accompanying document. The test methods described in GB9706.244-2020 and this document rely on the use of appropriate test equipment to carry out non-invasive measurements during or after installation. The steps covered during the installation process can be used as part of the acceptance test report after signing the declaration. This document applies to CT scanning devices that comply with GB9706.244-2020. This document applies to acceptance testing and stability testing of CT scanning devices. The purpose of acceptance testing is to verify that installation or major repairs that affect image quality, radiation output, and patient positioning comply with specifications. Stability testing is performed to ensure that the functional performance of the device complies with established guidelines and to enable early identification of performance changes in device components and to verify whether image quality, radiation output, and patient positioning are affected by compliance with specifications. This document also contains requirements for accompanying documentation related to acceptance testing and stability testing of CT scanning devices. This document does not apply to the following: 　——mechanical and electrical safety-related aspects; and — mechanical, electrical and software performance, unless they are necessary to perform acceptance and stability tests and directly affect image quality , radiation output and patient positioning.

GB/T 19042.5-2022 Referenced Document

• GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• GB 9706.244-2020 Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• GB/T 19629 Medical Electrical equipment-Dosimeters with ionization chambers and/or semi-conductors as used in X-ray diagnostic imaging

GB/T 19042.5-2022 history

• 2022 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
• 2015 GB/T 17006.11-2015 Evaluation and routine testing in medical imaging departments.Part 2-6:Constancy tests.Imaging performance of computed tomography X-ray equipment
• 2006 GB/T 19042.5-2006 Evaluation and routine testing in medical imaging department. Part 3-5: Acceptance tests. Imaging performances of computed tomography X-ray equipment
• 1997 GB/T 17006-1997 Evaluation and routine testing in medical imaging departments--Part 2-6: Constancy tests--X-ray equipment for computed tomography

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 has been changed from GB/T 17006.11-2015 Evaluation and routine testing in medical imaging departments.Part 2-6:Constancy tests.Imaging performance of computed tomography X-ray equipment.

GB/T 19042.5-2022 -All Parts