YY/T 0593-2022 English PDF (YYT0593-2022)

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YY/T 0593-2022: Transcranial doppler ultrasound system
YY/T 0593-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
CCS C 41
Replacing YY/T 0593-2015
Transcranial Doppler Ultrasound System
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 1, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 5
4 Product Classification ... 6
5 Requirements ... 6
6 Test Methods ... 9
Appendix A (informative) Measurement of Blood Flow Velocity Range Using
Frequency Shift Simulation Method ... 13
Transcranial Doppler Ultrasound System
1 Scope
This document specifies the terms and definitions, product classification, requirements and test
methods for transcranial doppler ultrasound system.
This document is applicable to transcranial doppler ultrasound system (hereinafter referred to
as TCD instrument).
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through the normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
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/T 14710 Environmental Requirement and Test Methods for Medical Electrical Equipment
YY/T 0458 Technical Requirements for Ultrasonically Blood-mimicking Doppler Phantom
YY/T 0704 Ultrasonics - Pulsed Doppler Diagnostic System - Test Procedures to Determine
Performance
YY/T 0705 Ultrasonics - Continuous-wave Doppler Systems - Test Procedures
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
What is defined in GB 9706.237, YY/T 0458, YY/T 0704 and YY/T 0705, and the following
terms and definitions are applicable to this document.
3.1 transcranial doppler ultrasound system
An equipment that utilizes the principle of ultrasound doppler to measure the blood flow in
intracranial blood vessels through the skull.
NOTE: by configuring the corresponding probe, it can also be used for blood flow measurement in
the extracranial neck and peripheral blood vessels.
3.2 nominal acoustic working frequency
Ultrasonic working frequency published by the designer or manufacturer.
NOTE: the unit is megahertz (MHz).
3.3 sample volume
When pulsed doppler is used to measure the blood flow velocity, the sampling area of the
measurement site.
NOTE 1: the unit is millimeters (mm).
NOTE 2: the width of the sample volume of the TCD instrument cannot be adjusted, and the length
of the sample volume can only be adjusted by controlling the duration of the pulse wave.
4 Product Classification
4.1 In accordance with the number of channels, it can be classified into:
a) Single-channel TCD instrument: an equipment with only one probe channel activated
at the same time and displaying the corresponding spectrum signal;
b) Dual-channel (multi-channel) TCD instrument: an equipment with two (or more)
probe channels activated at the same time and displaying the corresponding spectrum
signal.
4.2 In accordance with the number of depths that can be obtained through one channel, it can
be classified into:
a) Single-depth TCD instrument: an equipment that can obtain a doppler spectrum signal
at one depth from one probe channel;
b) Dual-depth (multi-depth) TCD instrument: an equipment that can simultaneously
obtain doppler spectrum signals at two depths (or multiple depths) from one probe
channel.
5 Requirements
5.1 Ultrasonic Working Frequency
The deviation between the ultrasonic working frequency and the nominal ultrasonic frequency
published by the manufacturer shall be not greater than  10%.
50 Hz, 100 Hz, 200 Hz and 400 Hz;
d) Spectrum analysis function;
e) Spectrum resolution setting;
f) Range gating setting;
g) Sampling area setting;
h) Receive gain adjustment;
i) Baseline movement;
j) Scale setting;
k) Parameter measurement: in the frozen state of the atlas, velocity, acceleration,
vascular pulsation index (PI) and vascular resistance index (RI) can be measured;
l) The range gating parameters of each channel of the dual-channel TCD instrument can
be independently adjusted.
5.8 Appearance and Structure
5.8.1 The outer casing of the TCD instrument shall have no obvious mechanical damage, rust
and other defects, and the texts and logos on the panel shall be clearly visible.
5.8.2 The plastic parts of the TCD instrument shall be free from blistering, cracking,
deformation and overflow of filling material.
5.8.3 The operation and adjustment mechanism of the TCD instrument shall be flexible and
reliable, and the fasteners shall not be loose.
5.9 Safety
The TCD instrument shall comply with the requirements of GB 9706.1 and GB 9706.237.
5.10 Environmental Test
The environmental test requirements of the TCD instrument shall comply with the
manufacturer’s stipulations in accordance with the climatic environment test group I and the
mechanical environment test group II in GB/T 14710. The test time, recovery time and
inspection items shall comply with the supplementary stipulations in Table 2. The special
requirements and methods of environmental test can be implemented in accordance with the
principles and stipulations of YY/T 1420.
It is recommended use blood-mimicking phantoms and string-type test pieces. The
requirements for blood-mimicking phantoms can take YY/T 0458 as a reference; the
requirements for string-type test pieces can take YY/T 0705 as a reference.
6.2 Ultrasonic Working Frequency
In accordance with the method specified in YY/T 1142, carry out the test, which shall comply
with the requirements of 5.1.
6.3 Flow Velocity Measurement Range and Error
In accordance with the interval of the flow velocity measurement range, different test methods
can be adopted. When the set value of the measured flow velocity is within the range of Table
1, adopt the blood-mimicking phantoms or string-type test pieces for the test. When the set
value of the measured flow velocity exceeds the measuring range of the blood-mimicking
phantoms or string-type test pieces, the method in Appendix A can be used for the test.
When blood-mimicking phantoms or string-type test pieces are used for the test, follow the
instructions for use of the blood-mimicking phantoms or string-type test pieces. The settings of
the TCD instrument under test are as follows:
a) Blood vessel selection, filtering, sound power and receive gain are adjusted to the
optimal position;
b) The working distance and sample volume are set in accordance with the stipulations
of Table 1;
c) It is recommended to select 30, 45 or 60 for the included angle between the doppler
sound beam axis (generally, the axis of the probe handle) and the target movement
direction. When calculating the displayed flow velocity error, in addition to the actual
angle mentioned above, it shall also be considered that the doppler angle of ...