YY/T 0937-2022 English PDF (YYT0937-2022)

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YY/T 0937-2022: Technical requirements for ultrasonically tissue-mimicking phantom
YY/T 0937-2022
Technical requirments for ultrasonically tissue-mimicking phantom
ICS 17.140.50
CCSC41
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0937-2014
Technical requirements for ultrasonic tissue-mimicking phantoms
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Technical requirements for tissue-mimicking phantoms 3
5 Accompanying documents for the tissue-mimicking phantom 4
6 Measurement method of technical parameters of tissue-mimicking phantom 4
7 Evaluation of tissue-mimicking phantoms4
Appendix A (Informative) Instructions on Two Measurement Methods of B-mode Ultrasound Imaging Detection Depth 5
Appendix B (Informative) Notes on TM Material and Target Line Technical Requirements 6
Appendix C (normative) Evaluation of tissue-mimicking phantoms 8
Reference 9
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 replaces YY/T 0937-2014 "Technical Requirements for Ultrasonic Tissue Mimic Phantoms", compared with YY/T 0937-2014, except for the structure
In addition to adjustments and editorial changes, the main technical changes are as follows.
--- Changed the content of "Terms and Definitions" (see Chapter 3, Chapter 3 of the.2014 edition);
--- Deleted the content of "Overview of Imitation Tissue Phantom" (see Chapter 4 of the.2014 edition);
--- Changed the requirements for "general phantoms and small organ phantoms" (see 4.1, 5.1 of the.2014 edition);
--- Changed the requirements of "accompanying documents of tissue-mimicking phantoms" (see Chapter 5, Chapter 6 of the.2014 edition);
--- Changed the content of "Explanation on TM Material and Target Line Technical Requirements" (see Appendix B, Appendix A of the.2014 edition);
--- Added the content of "evaluation of imitation tissue phantom" (see Chapter 7, Appendix C).
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 approved by the National Medical Electrical Equipment Standardization Technical Committee Medical Ultrasound Equipment Standardization Sub-Technical Committee (SAC/TC10/SC2)
focal point.
This document is drafted by. Institute of Acoustics, Chinese Academy of Sciences, Hubei Institute of Medical Device Quality Supervision and Inspection.
The main drafters of this document. Niu Fengqi, Zhu Chenggang, Jiang Shilin, Zhang Di, Cheng Yang, Wu Chengzhi.
The previous versions of this document and its superseded documents are as follows.
---YY/T 0937-2014.
Technical requirements for ultrasonic tissue-mimicking phantoms
1 Scope
This document specifies the technical requirements, accompanying documents, measurement methods and evaluation of ultrasound tissue-mimicking phantoms.
This document applies to ultrasound tissue-mimicking phantoms.
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/T 4472 Determination of Density and Relative Density of Chemical Products
GB 10152-2009 Type B Ultrasound Diagnostic Equipment
GB/T 15261 Method for measuring the acoustic properties of ultrasonic tissue-mimicking materials
YY/T 0703-2008 Ultrasonic real-time pulse echo system performance test method
3 Terms and Definitions
Terms and definitions defined in GB 10152-2009, YY/T 0703-2008 and the following apply to this document.
3.1
A B-type ultrasonic imaging performance testing device is composed of ultrasonic tissue-like material and one or more groups of targets embedded in it.
[Source. GB 10152-2009, 3.8, with modifications]
3.2
Ultrasonicalytissue-mimickingmaterial
In the ultrasonic frequency band, its sound velocity, attenuation coefficient, backscatter coefficient and other characteristics are similar to those of soft tissue materials.
Note. referred to as TM material.
[Source. GB 10152-2009, 3.10, with modifications]
3.3
The relationship between the sound attenuation coefficient of the TM material and the frequency is the slope of the straight line fitted through the origin of the rectangular coordinate system.
Note. The unit is decibel per centimeter megahertz, dB/(cm·MHz).
3.4
target
Embedded in the TM material of the ultrasonic phantom, it is used to detect targets with specific properties of the B-mode ultrasonic imaging instrument, such as nylon monofilament, non-return
Wave cylinders (imitation cysts), strongly scattering cylinders (imitation tumors), inorganic non-metallic particles (imitation stones), planar layers with specified scattering levels and thicknesses,
Ovals with different backscatter from background, series of cylinders, cones, etc. with different backscatter.
3.5
Close to the lower surface of the acoustic window of the ultrasound phantom, different distances from the acoustic window, arranged obliquely in sequence, and used to detect the blind area of B-mode ultrasound imaging.