YY/T 0593-2022 (YY/T0593-2022, YYT 0593-2022, YYT0593-2022) & related versions
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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 the TCD
instrument is set to 0;
d) When testing the flow velocity measurement range, the flow velocity of the phantoms
is respectively set at the maximum value and minimum value of the flow velocity
measurement range of the TCD instrument under test; when the flow velocity
measurement range of the TCD instrument 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;
e) When testing the flow velocity measurement error, the flow velocity of the phantoms
is respectively set at 1/3 and 2/3 of the flow velocity measurement range of the TCD
instrument under test.
The test results shall comply with the requirements of 5.2 and 5.3.
6.4 Working Distance
Adopt the blood-mimicking phantoms or string-type test pieces, at the nominal maximum
working distance and minimum working distance, use a TCD instrument to detect the target.
Check whether the displayed frequency spectrum is normal, which shall comply with the
requirements of 5.4.
6.5 Range Gating Error
The sample volume of the TCD instrument is recommended to be set to 4 mm and 20 mm, and
other statuses are set to the optimum. Adopt the ultrasonically blood-mimicking doppler
phantom. It is recommended that the distance between the tested point of the blood-mimicking
phantom and the probe be set at 50 mm. Set the range gating of the TCD instrument also to 50
mm and use the TCD instrument to detect the tested point of the blood-mimicking phantom. At
this moment, the TCD instrument shall have obvious doppler spectrum signals. Increase or
decrease the set value of the range gating, find the point with the strongest signal to read the
range gating, or find the position with the same signal strength in the upward and downward
directions. Record the range gating set values in both directions and take the average value. The
absolute value of the difference from the actual value (50 mm) is used as the range gating error
of the two sample volumes of 4 mm and 20 mm, and the most unfavorable value shall comply
with the requirements of 5.5.
A TCD instrument with M mode functions can use the M mode display window to accurately
find the test signal. By selecting the strongest point of the signal band on the M mode display
window, the range gating of this signal can be read.
6.6 Ultrasonic Output Power Adjustment
Successively adapt probes with different operating frequencies and operating modes to the TCD
instrument, respectively observe their spectrum signal strengths when the output power is set
to the relatively small and large values. There shall be corresponding changes, which shall
comply with the requirements of 5.6.
6.7 Working Status and Function Settings
Operate in accordance with the stipulations of the instruction manual and verify by checking
the screen display and working status, which shall comply with the requirements of 5.7.
6.8 Appearance and Structure
Conduct visual inspection and operation inspection, which shall comply with the requirements
of 5.8.
6.9 Safety
Conduct the test in accordance with the stipulations of GB 9706.1 and GB 9706.237, which
shall comply with the requirements of 5.9.
6.10 Environmental Test
......
YY/T 0593-2015
Ultrasound transcranial Doppler system
ICS 11.040.50
C41
People's Republic of China pharmaceutical industry standards
Replacing YY 0593-2005
Transcranial Doppler ultrasound analyzer
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 0593-2005 "transcranial Doppler ultrasound analyzer."
The main criteria for YY 0593-2005 technical differences are as follows.
--- Flow velocity measurement range and error put forward new requirements and test methods;
--- Increasing the minimum working distance indicators;
--- Increase the low-frequency probe selected from the index through error;
--- Delete the original 5.7 sound output disclosure requirements, incorporating the security requirements, the full implementation of GB 9706.9-2008;
--- Remove the original Appendix A, the full implementation of GB 9706.1-2007;
--- Adds an informative annex "with a frequency-shifted analog measurement of blood flow velocity range."
Please note that some content of this document may involve patents, the issuing authority of this document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2)
Centralized.
This standard was drafted. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center, Shenzhen City DS Likai electrons
Limited.
The main drafters of this standard. Jiang Shilin, Wang Xiaoyi, Wang Zhijian.
This standard was first released in December 2005.
Transcranial Doppler ultrasound analyzer
1 Scope
This standard specifies the transcranial Doppler ultrasound analyzer terms and definitions, product classifications, requirements, test methods, inspection rules and
Legends and use.
This standard applies to transcranial Doppler ultrasound analyzer (hereinafter referred to as TCD instrument).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191-2008 Packaging - Pictorial signs
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.9-2008 Medical electrical equipment - Part 2-37 ultrasound diagnostic and monitoring equipment - Safety requirements
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General Requirements for Safety Collateral Standard. Safety of medical electrical systems
Claim
GB/T 14710-2009 medical electrical environmental requirements and test methods
The technical requirements of YY/T 0458-2003 simulated Doppler blood flow phantoms
YY/T 0704-2008 pulsed Doppler ultrasound diagnostic system performance test method
YY/T 0705-2008 continuous wave Doppler ultrasound system test method
YY/T 1142-2005 Test Method for ultrasonic medical diagnostic and monitoring equipment frequency characteristics
3 Terms and Definitions
GB 9706.9-2008, YY/T 0458-2003, YY/T 0704-2008 and YY/T 0705-2008 and as defined in the following
The terms and definitions apply to this document.
3.1
Transcranial Doppler ultrasound ultrasoundtranscranialDoppler; TCD
Using ultrasonic Doppler principle intracranial blood flow measurement technology.
Note. You can also measure the extracranial blood flow.
3.2
Ultrasound nominal frequency nominalacousticworkingfrequency
Published by the designer or manufacturer of ultrasonic frequency.
Note. The unit is megahertz (MHz).
4 Products
4.1 according to the number of channels can be divided into.
Single-channel TCD instrument. that only one probe channel and activate the display device corresponding to the spectrum of the signal to a single channel
......
| Standard ID | YY/T 0593-2022 (YY/T0593-2022) | | Description (Translated English) | Transcranial doppler ultrasound system | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 10,114 | | Date of Issue | 2022-05-18 | | Date of Implementation | 2023-06-01 | | Older Standard (superseded by this standard) | YY/T 0593-2015 | | Drafting Organization | Hubei Provincial Institute of Medical Device Quality Supervision and Inspection, Shenzhen Delich Medical Equipment Co., Ltd. | | Administrative Organization | Medical Ultrasound Equipment Standardization Sub-Technical Committee of National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC 10/SC 2) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, product classification, requirements and test methods of ultrasonic transcranial Doppler flow analyzer. This standard applies to ultrasound transcranial Doppler flow analyzer. | | Standard ID | YY/T 0593-2015 (YY/T0593-2015) | | Description (Translated English) | Ultrasound transcranial Doppler system | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 10,128 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Older Standard (superseded by this standard) | YY 0593-2005 | | Quoted Standard | GB/T 191-2008; GB 9706.1-2007; GB 9706.9-2008; GB 9706.15-2008; GB/T 14710-2009; YY/T 0458-2003; YY/T 0704-2008; YY/T 0705-2008; YY/T 1142-2005 | | Drafting Organization | China Food & Drug Administration of Hubei Medical Devices Inspection Center | | Administrative Organization | National Medical Electrical Standardization Technical Committee of Medical Ultrasound Equipment Standardization Sub-Technical Committee | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This Standard specifies the transcranial Doppler ultrasound analyzer terms and definitions, product classifications, requirements, test methods, inspection rules and signs and instructions for use. This Standard applies to transcranial Doppler ultrasound analyzer. | | Standard ID | YY 0593-2005 (YY0593-2005) | | Description (Translated English) | Ultrasound transcranial Doppler system | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 17,192 | | Date of Issue | 2005-12-07 | | Date of Implementation | 2006-12-01 | | Drafting Organization | National Medical Ultrasound Equipment Quality Supervision and Testing Center | | Administrative Organization | National Standardization Technical Committee of Medical Ultrasound Equipment | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the transcranial Doppler ultrasound analyzer terminology and definitions, product classification, requirements, test methods, inspection rules and signs and instructions. This standard applies to transcranial Doppler ultrasound analyzer (hereinafter referred to as TCD instrument). |
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