Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This document is developed in accordance with the rules given in GB/T 1.1-2020 Directives for standardization — Part 1: Rules for the structure and drafting of standardizing documents.
This standard replaces YY/T 0937-2014 Technical requirements for ultrasonically tissue-mimicking phantom. In addition to structural adjustments and editorial changes, the following main technical changes have been made with respect to YY/T 0937-2014:
——The contents of “Terms and definitions” have been modified (see Clause 3 herein; Clause 3 in 2014 edition);
——The contents of "Overview of tissue-mimicking phantom" have been deleted (see Clause 4 in 2014 edition);
——The requirements for "General phantom and small part phantom" have been modified (see 4.1 herein; 5.1 in 2014 edition);
——The requirements for accompanying documents on tissue-mimicking phantom have been modified (see Clause 5 herein; Clause 6 in 2014 edition);
——The contents of "Description on technical requirements for TM materials and target lines" have been modified (see Annex B herein; Annex A in 2014 edition);
——The contents of "Evaluation of tissue-mimicking phantom" have been added (see Clause 7 and Annex C).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This document was proposed by the National Medical Products Administration of the People’s Republic of China.
This document is under the jurisdiction of Subcommittee of medical ultrasonic equipment of the National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 2).
The previous edition of this document and the document replaced by this document is as follows:
——YY/T 0937-2014.
Technical requirements for ultrasonically tissue-mimicking phantom
1 Scope
This document specifies the technical requirements, accompanying documents, measurement methods and evaluation of ultrasonically tissue-mimicking phantom.
This document is applicable to ultrasonically tissue-mimicking phantom.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 4472 General rule for determination of density and relative density for chemical products
GB 10152-2009 B mode ultrasonic diagnostic equipment
GB/T 15261 Measurement methods for acoustic properties of ultrasonically tissue-mimicking materials
YY/T 0703-2008 Ultrasonics — Real-time pulse-echo systems — Test procedures to determine performance specifications
3 Terms and definitions
For the purpose of this document, the terms and definitions given in GB 10152-2009 and YY/T 0703-2008 as well as the following terms and definitions apply.
3.1
ultrasonically tissue-mimicking phantom; ultrasound tissue phantom
B mode ultrasonic imaging performance testing device composed of an ultrasonic tissue-mimicking material and one or more groups of targets embedded therein
[Source: GB 10152-2003, 3.8, modified]
3.2
ultrasonically tissue-mimicking material
material whose characteristics such as sound velocity, attenuation coefficient and backscattering coefficient are similar to those of soft tissue
Note: This material is called TM material for short.
[Source: GB 10152-2009, 3.10, modified]
3.3
sound attenuation coefficient slope
slope of fitting straight line of the relationship between sound attenuation coefficient and frequency of TM material through the origin of rectangular coordinate system
Note: The sound attenuation coefficient slope is expressed in dB/(cmM·Hz).
3.4
target
object embedded in TM material of ultrasonic phantom, which is used for testing the specific performance of B mode ultrasonic imaging instruments, such as nylon monofilament, echo-free cylinder (mimicked cyst), strong scattering cylinder (mimicked tumor), inorganic nonmetallic particles (mimicked stone), planar layer with specified scattering level and thickness, ovoid with different backscattering from background, series of cylinders with different backscattering, cone
3.5
target group for dead zone
group of nylon linear targets closed to the lower surface of the phantom scanning surface of the phantom and arranged obliquely at different distances to the phantom scanning surface, which are used for testing the dead zone of B mode ultrasonic imaging, in which the longitudinal distance between adjacent target lines is usually 1 mm
3.6
longitudinal linear target group
group of nylon linear targets under the phantom scanning surface of ultrasonic phantom and arranged in a straight line in equal distance along the longitudinal direction, which are used for testing the longitudinal ranging accuracy and test depth of B mode ultrasonic imaging
Note: See Annex A for the description of the two measurement methods for depth of penetration of B mode ultrasonic imaging.
3.7
transverse linear target group
group of nylon linear targets under the phantom scanning surface of ultrasonic phantom and arranged in a straight line in equal distance along the transverse direction, which are used for testing the transverse ranging accuracy of B mode ultrasonic imaging
3.8
target group for axial resolution
several groups of nylon linear targets in a designated depth of the ultrasonic phantom, arranged along curve or diagonal in different longitudinal distance, which are used for testing the axial resolution of B mode ultrasonic imaging
3.9
target group for lateral resolution
several groups of nylon linear targets in a designated depth of the ultrasonic phantom, arranged along transverse straight line in different transverse distance, which are used for testing the lateral resolution of B mode ultrasonic imaging
3.10
multi-purpose phantom
ultrasonically tissue-mimicking phantom composed of background TM material, a number of linear target groups embedded in the TM material (usually including target group for dead zone, longitudinal linear target group, transverse linear target group, target group for axial resolution, target group for lateral resolution) and targets mimicking cysts, tumors, stones and other lesions, which are used for testing most performance parameters such as dead zone, test depth, axial/lateral resolution, longitudinal/transverse geometric measurement error, etc. of low-frequency (usually below 5MHz) B mode ultrasonic imaging instrument, and for examining the image uniformity and imaging conditions of typical foci
3.11
small part phantom
ultrasonically tissue-mimicking phantom composed of background TM material, a number of linear target groups embedded in the TM material (usually including target group for dead zone, longitudinal linear target group, transverse linear target group, target group for axial resolution, target group for lateral resolution) and targets mimicking cysts, tumors and other lesions, which are used for testing dead zone, test depth, axial/lateral resolution, longitudinal/transverse geometric error of high-frequency (usually 5MHz and more) B mode ultrasonic imaging instrument, and for examining the image uniformity and imaging conditions of typical foci
Note: Because the object under the diagnosis of the corresponding B mode ultrasonic imaging instrument is in a shallow position, high-frequency probe has higher spatial resolution and lower test depth. The basic characteristics of small part phantom differentiating it from multi-purpose phantom are: the overall size, size and resolution of mimicked focus, the distance between target lines in the target groups for resolution is smaller, and the uppermost target line and mimicked focus position in the target groups for dead zone are closer to the phantom scanning surface.
3.12
slice thickness phantom
ultrasonically tissue-mimicking phantom, composed of background TM material, scattering layer with or without backplate and (or) longitudinal linear target group embedded in it, which is specially designed for testing the thickness parameters for sound beam slice of B mode ultrasonic imaging instrument
3.13
three-dimensional (3D) phantom
ultrasonically tissue-mimicking phantom, composed of background TM material and the oval target embedded in it, which is specially designed for testing the volume measurement error in three-dimensional imaging
Note: Usually, the background TM material and the target have similar sound attenuation characteristics, but obviously different backscattering characteristics.
3.14
contrast resolution phantom
ultrasonically tissue-mimicking phantom composed of background TM material and embedded cylindrical, conical or pagoda-shaped targets with backscattering coefficient higher or lower than the background, which is used for testing the contrast resolution parameters of B mode ultrasonic imaging instrument
3.15
dynamic range phantom
ultrasonically tissue-mimicking phantom, composed of low-attenuation non-scattering gel and high-attenuation scattering gel step by step along the depth direction, which is specially used for testing the dynamic range parameters of B mode ultrasonic imaging instrument
4 Technical requirements for tissue-mimicking phantom
4.1 Multi-purpose phantom and small part phantom
4.1.1 Sound velocity of TM material
The sound velocity of TM material used in multi-purpose phantom and small part phantom should be (1,540 ± 10) m/s.
Note: The sound velocity is measured at (23 ± 3)°C. In order to meet the test requirements of specific B mode ultrasonic performance indexes, phantom users may also choose phantom with specific sound velocity, which, however, shall be indicated in the report. See Annex B for the description on technical requirements for sound velocity of TM materials.
4.1.2 Sound attenuation coefficient slope of TM material
The sound attenuation coefficient slope of TM materials used in multi-purpose phantom and small part phantom should be between 0.2 dB/(cm·MHz) and 0.9 dB/(cm·MHz). Phantom users may choose appropriate values according to their purposes, such as median of 0.7 dB/(cm·MHz), 0.5 dB/(cm·MHz) or 0.25 dB/(cm·MHz). If not specified, (0.7 ± 0.05) dB/(cm·MHz) should be adopted.
Note: The sound attenuation coefficient slope is measured at (23 ± 3)°C. See Annex B for the description on technical requirements for sound attenuation coefficient slope of TM materials.
4.1.3 Diameter of nylon target line
The diameter of nylon target wire used in multi-purpose phantom and small part phantom should be (0.3 ± 0.05) mm or (0.1 ± 0.02) mm, and the phantom users may choose appropriate values according to their purposes. If not specified, (0.3±0.05) mm should be adopted.
Note: See Annex B for the description on technical requirements for Nylon target lines.
4.1.4 Position tolerance of nylon target line
The position tolerance of nylon target line used in multi-purpose phantom and small part phantom should be within ±0.1 mm.
4.1.5 Spacing between adjacent target lines in longitudinal linear target group
The spacing between adjacent target lines in longitudinal linear target group of multi-purpose phantom and small part phantom should be 10 mm.
4.1.6 Spacing between adjacent target lines in transverse linear target group
The spacing between adjacent target lines in transverse linear target group of multi-purpose phantom and small part phantom should be 10 mm or 20 mm.
4.2 Special phantom
The requirements for acoustic characteristics of background TM material in special phantom are the same as those for multi-purpose phantom. See Table 1 for requirements of other relevant parameters.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements for tissue-mimicking phantom
5 Accompanying documents on tissue-mimicking phantom
6 Measurement method for technical parameters of tissue-mimicking phantom
7 Evaluation of the tissue-mimicking phantom
Annex A (Informative) Description on the two measurement methods for depth of penetration of B mode ultrasonic imaging
Annex B (Informative) Description on technical requirements for TM materials and target lines
Annex C (Normative) Evaluation of the tissue-mimicking phantom
Bibliography
