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YY/T 0767-2023: General technical requirements for color ultrasound imaging equipment
YY/T 0767-2023. General technical requirements for color ultrasound imaging equipment
ICS 11.040.50
CCSC41
Pharmaceutical Industry Standards of the People's Republic of China
Replace YY/T 0767-2009
General technical requirements for color ultrasound imaging equipment
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Table of contents
PrefaceⅠ
1 range 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Requirements 2
5 Test method 3
Appendix A (informative) Doppler performance parameters and test equipment 6
Appendix B (informative) Considerations for setting various parameters during color ultrasound testing 9
Preface
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 replaces YY/T 0767-2009 "Ultrasound Color Blood Flow Imaging System". Compared with YY/T 0767-2009, except for structural adjustments
In addition to editorial changes, the main technical changes are as follows.
---Modified the "scope" (see Chapter 1, Chapter 1 of the.2009 edition);
---Modified "Terms and Definitions" (see Chapter 3, Chapter 3 of the.2009 edition);
---Deleted "normal working conditions" (see 4.1 of the.2009 version);
---Added "General Provisions" (see 4.1);
---Modify the requirements and test methods for "color blood flow imaging mode" (see 4.2 and 5.2,.2009 version of 4.2 and 5.2);
---Modified the requirements and test methods for "spectral Doppler mode" (see 4.3 and 5.3,.2009 version of 4.3 and 5.3);
--- Added requirements and test methods for "power Doppler mode" (see 4.4 and 5.4);
---Added "appearance and structure" requirements and test methods (see 4.6 and 5.6);
---Added "use function" requirements and test methods (see 4.7 and 5.7);
---Modified the requirements and test methods for "environmental testing" (see 4.8 and 5.8, 4.5 and 5.5 of the.2009 edition);
---Modified the "Overview" (see 5.1, 5.1 of the.2009 version);
---Deleted the "inspection rules" (see Chapter 6 of the.2009 edition);
---Deleted "Logo and Instructions for Use" (see Chapter 7 of the.2009 edition);
---Deleted "Measurement and publication of the highest and lowest detectable flow rates" (see Appendix B of the.2009 version).
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 National Medical Products Administration.
This document is under the jurisdiction of the Medical Ultrasound Equipment Sub-Technical Committee (SAC/TC10/SC2) of the National Technical Committee for Standardization of Medical Electrical Appliances.
This document was drafted by. Hubei Institute of Medical Device Quality Supervision and Inspection, Institute of Acoustics, Chinese Academy of Sciences, Shenzhen Mindray Biomedical
Medical Electronics Co., Ltd., General Electric Medical Systems (China) Co., Ltd., and Wuxi Haiying Medical Technology Co., Ltd.
The main drafters of this document. Wang Zhijian, Jiang Shilin, Niu Fengqi, Zhu Lei, Liu Zhenyu, Wang Guoying, and Wu Chengzhi.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2009 as YY 0767-2009.
---This is the first revision.
General technical requirements for color ultrasound imaging equipment
1 Scope
This document specifies the requirements for color ultrasound imaging equipment (referred to as "color ultrasound") and describes the corresponding test methods.
This document applies to color ultrasound imaging equipment.
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 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance
GB 9706.237 Medical electrical equipment Part 2-37.Ultrasonic diagnostic and monitoring equipment for basic safety and basic performance
Require
GB 10152 Type B ultrasonic diagnostic equipment
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance Parallel standards for electromagnetic compatibility
Capacity requirements and testing
YY/T 0458 Technical requirements for ultrasonic Doppler blood imitation fluid model
YY/T 0705 Ultrasonic continuous wave Doppler system test method
YY/T 1420 Environmental requirements and test methods for medical ultrasound equipment
3 Terms and definitions
The following terms and definitions as defined in GB 10152 apply to this document.
3.1
Using ultrasonic Doppler technology and ultrasonic echo principles to collect blood flow movement information, tissue movement information and tissue structure information for color analysis
Imaging equipment.
Note. The operating frequency of color ultrasound is usually in the range of 1MHz~15MHz.
3.2
Color Doppler colorDoppler
Doppler and autocorrelation techniques are used to image blood flow, and color-coded information is superimposed on the B-mode grayscale image for real-time display.
Methods.
Note. Also called color flow imaging.
Spectral DopplerspectralDoppler
The principle of ultrasonic Doppler is used to extract the direction, speed, energy and other information of blood flow, and then processed in the form of spectrum-time or flow velocity-time.
The technical method for displaying the formula.