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 standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 standard shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of Subcommittee on Ultrasonic Equipment of the National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 2).
Drafting organizations of this standard: Shenzhen University, Hubei Medical Devices Quality Supervision and Test Institute, and Shenzhen Mindray Biomedical Electronics Co., Ltd.
Chief drafters of this standard: Chen Xin, Chen Siping, Jiang Shilin, Wang Zhijian, Wu Chengzhi, Ke Hu, Li Shuangshuang, Zhu Lei.
Introduction
This standard is applicable to external-vibration based ultrasonic elasticity measurement equipment for liver tissue. The requirements and test methods of equipment for measuring elasticity of other human tissues using the same principle may refer to this standard.
General-purpose ultrasonic diagnostic equipment may refer to this standard if it also includes elasticity measurement function using the same principle.
External-vibration based ultrasonic elasticity measurement equipment for liver tissue
1 Scope
This standard specifies the requirements, test conditions and test methods of external-vibration based ultrasonic elasticity measurement equipment for liver tissue (hereinafter referred to as “equipment”).
This standard is applicable to the equipment that excites shear wave in liver tissue through external low-frequency vibration and uses ultrasonic pulse-echo method to measure the elasticity of liver tissue.
Note: The external-vibration based ultrasonic elasticity measurement technology for liver tissue applicable to this standard corresponds to the instantaneous elasticity image in the classification of ultrasound elastography which is shown in Annex A.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
GB 9706.237 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
GB 10152 B mode ultrasonic diagnostic equipment
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
YY/T 1142 Methods of measuring the frequency of medical ultrasonic equipment and probe
YY/T 1420 Environmental requirement and test methods for medical ultrasonic equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 10152 and the following apply.
3.1
external-vibration based ultrasonic elasticity measurement equipment for liver tissue
equipment that applies low-frequency vibration through the skin from outside the body through a mechanical device, generates shear wave propagation in the liver tissue, conducts measurement by ultrasonic pulse-echo method, and calculates and displays the elastic parameters of the liver tissue (Young’s modulus and/or shear wave speed and shear modulus) according to the echo information
3.2
ultrasonically tissue-mimicking phantom, ultrasound tissue phantom
B-mode ultrasonography performance detection device that is composed of tissue-mimicking materials and one or more groups of targets embedded in them
[YY/T 0937-2014, definition 3.1]
3.3
sono-elasticity tissue-mimicking phantom
passive device composed of ultrasonic elasticity tissue-mimicking materials in different ways, which is used to test the performance of ultrasonic elasticity image diagnosis equipment
[YY/T 1521-2017, definition 3.1]
3.4
depth of ultrasonic penetration
distance between the farthest target line and the acoustic window in the longitudinal linear target group which can be clearly imaged (or displayed as echo signal along the ultrasonic beam axis) in the ultrasonically tissue-mimicking phantom
Note: Unit: mm.
3.5
measurement accuracy
consistency between the measured value and the nominal value of the measurand. In this standard, the measurement accuracy, expressed as absolute error or relative error, shall be calculated using Equations (1) and (2):
(1)
(2)
where,
Δ——the absolute error;
——the arithmetic average of each measurement;
μ——the nominal value;
δ——the relative error, usually expressed as a percentage.
3.6
repeatability of measurements
consistency between successive measurements of the same measurand under the same measurement conditions, which is calculated using Equation (3):
(3)
where,
s——the coefficient of variation;
xi——the value of a single measurement;
——the arithmetic average of each measurement;
n——the number of measurements.
4 Requirements
4.1 Safety requirements
The safety of the equipment shall meet the requirements of GB 9706.1 and GB 9706.237.
4.2 Ultrasonic working frequency
The deviation between the ultrasonic working frequency and the value specified by the manufacture shall be within ± 15%.
4.3 Depth of ultrasonic penetration
Depth of ultrasonic penetration shall meet the requirements specified by the manufacturer.
4.4 Measurement accuracy of Young’s modulus
The measurement accuracy of Young’s modulus shall meet the requirements specified by the manufacturer.
4.5 Repeatability of measurements of Young’s modulus
The Repeatability of measurements of Young’s modulus shall meet the requirements specified by the manufacturer.
4.6 Functions
The equipment shall have the use functions specified by the manufacturer in the accompanying documents, which shall at least include an indication of whether the pressure is appropriate during operation.
Note: This article does not cover product design parameters or functional items that cannot be verified by intuitive test means.
4.7 Accompanying documents
The following contents shall be specified in the accompanying documents:
a) Whether there is a guiding function during selecting the measuring position;
b) The frequency of the applied external mechanical vibration;
c) Depth range of detecting elasticity of liver tissue.
4.8 Environment tests
The environmental test requirements of equipment shall be carried out by the manufacturer according to the provisions of climate environment test group II and mechanical environment test group II in GB/T 14710, and the test time, recovery time and test items shall be carried out according to the supplementary provisions in Table 1. Special requirements and methods for environment tests may be implemented in accordance with the principles and requirements of YY/T 1420.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test conditions
6 Test methods
Annex A (Informative) Classification of elasticity imaging technology
Bibliography
