GB/T 19042.7-2025Evaluation and routine testing in medical imaging departments - Part 3-7: X-ray equipment for dental cone beam computed tomography 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 Parts 3-7 of GB/T 19042 "Evaluation and Routine Testing of Medical Imaging Systems". GB/T 19042 has been published.

The following section.

---Part 3-1.Acceptance Testing of Imaging Performance of X-ray Equipment for X-ray Radiography and Fluoroscopy Systems;

---Part 3-2.Acceptance Test of Imaging Performance of Mammography X-ray Equipment;

---Part 3-3.Acceptance Test of Imaging Performance of Digital Subtraction Angiography (DSA) X-ray Equipment;

---Parts 3-4.Acceptance Test of Imaging Performance of Dental X-ray Equipment;

---Parts 3-5.Acceptance and Stability Tests of X-ray Computed Tomography Equipment Imaging Performance;

---Parts 3-6.Imaging Performance Acceptance and Stability Testing of Mammography X-ray Equipment in Breast Tomography Synthetic Imaging Mode;

---Parts 3-7.Imaging performance acceptance and stability test of cone-beam computed tomography X-ray equipment for oral and maxillofacial region.

This document is modified to adopt IEC 61223-3-7:2021 "Evaluation and routine testing of medical imaging components - Part 3-7.Acceptance and stability".

"Sexual testing of the imaging performance of cone-beam computed tomography (CBCT) X-ray equipment for oral and maxillofacial region".

The technical differences between this document and IEC 61223-3-7:2021, and the reasons therefor, are as follows.

---IEC 60601-1-3 and IEC 60336 (see 5.1) have been replaced by the normatively referenced GB 9706.103 and YY/T 0063, respectively.

Adapt to my country's technological conditions;

---The measurement method for parameter d has been changed (see 5.8.3), from being obtained by actual measurement through scanned volume images to being obtained by actual measurement, because...

The parameter d cannot be obtained through actual measurement of scanned volumetric images;

---Change 2%~3% of the phantom image to 2%~3% of the phantom image area (see 5.9.3) to make its meaning clearer.

The following editorial changes have been made to this document.

---To align with existing standards, the standard title has been changed to "Evaluation and Routine Testing of Medical Imaging Systems Parts 3-7.Oral and Maxillofacial Regions".

"Acceptance and Stability Tests of Imaging Performance of Cone-Beam Computed Tomography X-ray Equipment"

---The informational reference GB 9706.263 replaces IEC 60601-2-63:2012 AMD1.2017 AMD2.2021 (see GB 9706.263).

Chapter 1);

---IEC 60601-1 (all parts) has been replaced with GB 9706.1 (all parts) for informative reference (see Chapter 1);

---IEC 61223-3-4 and IEC 61223-3-5 have been replaced by the informative references GB/T 19042.4 and GB/T 19042.5 respectively (see Chapter 1);

---Notes in sections 4.4 and 4.6 have been deleted;

---Change the average value Kd in 5.4.1 to Kd to correct the error in the original text;

---Change the highest resolution in 5.5.1 to geometric precision to correct the error in the original text and maintain consistency with the context;

---Change note 2 in 5.5.3 to "The ratio of b to p represents the voxel size measured from the image";

---Change the content of Note 1 in 5.9.3 to "One possible regional distribution is shown in B.3";

---Note added to A.6;

---The reference to the phantom description in B.1 has been changed from "The description of the phantom is in B.2" to "The description of the phantom is in Appendix C," correcting the error.

Errors in the original text;

---B.2.2 has been deleted because it is inconsistent with the content suggested by the title of B.2 and is redundant with the content of A.6; B.2.3 has been changed to B.3 was removed because its title was inconsistent with the content suggested by B.2; the title of B.2.1 was also removed because the revised B.2 no longer consists of bullet points.

---Change Figure B.5 to Figure B.3;

---Change Figure E.1 in note D.1.1 to Figure B.1 to correct the error in the original text;

---Change the differential convolution kernel [-1,0,-1] or [-0.5,0,-0.5] in D.2 to [-1,0,1] or [-0.5,0,0.5] to correct it.

Errors in the original text;

---The spatial frequency merging interval in D.2 has been changed from 2fint to fint, correcting an error in the original text;

---Adjust the lower suspension section of E.2.3 to E.2.3.1, and revert the original E.2.3.1 to E.2.3.2;

---Move the line number mmax and line number mmin corresponding to the maximum value P"max and minimum value P"min from E.2.2.3 to E.2.2.4.

This makes the context flow better;

---The statement "The determination of this value is related to the information obtained from the image (see 5.6)" in G.3 has been deleted, correcting an error in the original text;

---Changed the source of the term "pixel" in the index, changing IEC 61223-3-5:2019,3.18 to IEC TR60788:2004,rm-32-60, Correcting errors in the original text.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Electrical Appliances (SAC/TC10).

Introduction

GB/T 19042, "Evaluation and Routine Testing of Medical Imaging Equipment," establishes a system of methods for acceptance testing and stability testing of diagnostic X-ray equipment.

The system is proposed to be divided into the following 7 parts.

---Part 3-1.Acceptance Testing of Imaging Performance of X-ray Equipment for X-ray Radiography and Fluoroscopy Systems. The purpose is to provide X-ray imaging performance testing...

Test methods and requirements related to X-ray equipment for radiographic and fluoroscopic systems.

---Part 3-2.Acceptance Test of Mammography X-ray Equipment Imaging Performance. The purpose is to provide acceptance testing results for mammography X-ray equipment.

Such as the relevant test methods and requirements.

---Part 3-3.Acceptance Test of Digital Subtraction Angiography (DSA) X-ray Equipment Imaging Performance. The purpose is to provide a performance evaluation result for digital subtraction angiography (DSA) X-ray equipment.

Test methods and requirements related to X-ray equipment for angiography.

---Part 3-4.Acceptance Testing of Imaging Performance of Dental X-ray Equipment. The purpose is to provide relevant testing methods for dental X-ray equipment.

Methods and requirements.

---Parts 3-5.Acceptance and Stability Tests of X-ray Computed Tomography Equipment. The purpose is to provide X-ray...

Test methods and requirements related to computed tomography equipment.

---Parts 3-6.Acceptance and Stability Testing of Mammography X-ray Equipment in Breast Tomography Synthetic Imaging Mode.

The purpose is to provide experimental methods and requirements related to mammography X-ray equipment imaging in the breast tomographic synthetic imaging mode.

---Parts 3-7.Imaging performance acceptance and stability testing of the cone-beam computed tomography (CBCT) X-ray equipment for the oral and maxillofacial region. Purpose the purpose is to provide experimental methods and requirements related to imaging with cone-beam computed tomography (CBCT) equipment for the oral and maxillofacial region.

This document provides methods for acceptance testing and stability testing of cone-beam computed tomography (CBCT) X-ray equipment for the oral and maxillofacial region.

For headings, paragraphs, or table items marked with an asterisk (*), guidelines or justifications are provided in Appendix A and Appendix B.

Evaluation and routine testing of medical imaging departments Parts 3-7.Cone-beam computed tomography of the oral and maxillofacial region X-ray imaging equipment imaging performance acceptance and Stability test

1 Purpose and Scope

This document applies to cone-beam computed tomography (CBCT) X-ray equipment for the oral and maxillofacial region as specified in GB 9706.263-2020 (hereinafter referred to as...).

(Dental CBCT equipment).

Note 1.Oral CBCT equipment is a subcategory of extraoral imaging dental X-ray machines.

Note 2.Extraoral imaging dental X-ray machines can provide one or more imaging modes among panoramic, cephalometric, tomographic, and oral CBCT, all of which are imaging modes all of these formulas fall within the scope of the GB 9706.263 basic safety and performance standards.

This document applies to the acceptance and stability tests of the imaging performance of cone-beam computed tomography (CBCT) X-ray equipment for the oral and maxillofacial region.

The purpose of acceptance testing is to verify whether the installation or major maintenance complies with the standards that affect image quality, radiation output, and patient positioning.

The requirements specified in this document are minimum requirements. Manufacturers may develop testing standards that exceed the levels specified in this document.

Stability testing is conducted to ensure that the functional performance of medical electrical equipment (ME equipment) meets established standards and to promptly identify any issues.

The performance of ME equipment components was examined to verify compliance with specifications affecting image quality, radiation output, and patient positioning.

This document also includes requirements for accompanying documentation related to the acceptance and stability testing of dental CBCT equipment.

This document does not apply to.

--- Thermal, electromagnetic interference (EMD), mechanical and electrical safety aspects;

---Regarding mechanical, electrical, and software performance, unless they are essential for acceptance and stability testing and directly affect the image...

Quality, radiation output, and patient positioning.

Note 3.These aspects are generally specified by GB 9706.1 (all parts).

Equipment within the scope of GB/T 19042.5 is not within the scope of this document.

Extraoral imaging dental X-ray machines can provide modes within the range of GB/T 19042.4, in which case, suitable for Relevant clauses in GB/T 19042.4.

The purpose of this document is to stipulate.

---Basic performance parameters of dental CBCT equipment related to image quality, radiation output, and patient positioning;

---A method for testing and determining whether the measurements related to the above parameters meet the specified requirements.

These methods rely on non-invasive measurements performed after installation or major maintenance.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

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

This document.

GB 9706.103 Medical Electrical Equipment - Part 1-3.General Requirements for Basic Safety and Basic Performance (Parallel Standard). Diagnostic X Radiation protection for radiation equipment (GB 9706.103-2020, IEC 60601-1-3:2013, MOD) YY/T 0063 Medical Electrical Equipment - Focal Dimensions and Related Characteristics of Medical Diagnostic X-ray Tube Assemblies (YY/T 0063-2024, IEC 60336:2020, MOD)