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YY/T 0458-2014: Technical requirements for ultrasonically blood-mimicking Doppler phantom
Status: Valid YY/T 0458: Evolution and historical versions
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| YY/T 0458-2014 | English | 529 |
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Technical requirements for ultrasonically blood-mimicking Doppler phantom
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YY/T 0458-2014
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| YY/T 0458-2003 | English | 879 |
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Technical requirements for ultrasonically blood-mimicking Doppler phantom
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YY/T 0458-2003
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Basic data | Standard ID | YY/T 0458-2014 (YY/T0458-2014) | | Description (Translated English) | Technical requirements for ultrasonically blood-mimicking Doppler phantom | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 17.140.50 | | Word Count Estimation | 23,236 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY/T 0458-2003 | | Quoted Standard | GB/T 4472; GB/T 15261; GB/T 18022; YY/T 0704; YY/T 0705 | | Adopted Standard | IEC 61685-2001, MOD | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to imitation by ultrasonic tissue material, embedded pipes buried in the material and make ultrasound steady flow of fake blood in the pipeline consisting of Doppler blood flow phantom imitation, the device is mainly used Doppler blo | YY/T 0458-2014: Technical requirements for ultrasonically blood-mimicking Doppler phantom---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Technical requirements for ultrasonically blood-mimicking Doppler phantom
ICS 17.140.50
C41
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0458-2003
Technical requirements for imitate blood flow Doppler phantoms
(IEC 61685.2001, Ultrasonics-Flowmeasurementsystems-
Flowtestobject, MOD)
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Table of Contents
Preface Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Symbol Table 5
5 imitation blood flow phantom outline 5
6 imitation blood flow phantom technical requirements 7
7 measures to prevent fake blood components to modify and eliminate air bubbles 9
8 9 Technical specifications identify the content
Measurement Method 9 simulated blood flow phantom main technical parameters of 10
Relations Annex A (informative) Standards and the technical documents 11
Appendix B (normative) contact each amount of formula 13
Annex C (informative) Description of the standard value of 15 selected
Annex D (informative) Imitation body flow Doppler pattern product test 17
Annex E (informative) Doppler phantoms and simulated blood flow control system diagram 18
References 19
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Instead of the standard YY/T 0458-2003 "imitation blood flow Doppler ultrasound phantom technical requirements."
Compared with YY/T 0458-2003, mainly technical changes include.
--- Original based on international standards, on the basis of repeated scrutiny and research on the translation has been modified, the statement more accurate;
--- International standard referenced in the original standard, after 2003 who have converted to domestic standards, references to national standards;
--- Remove ambiguity and a small amount of meaning in the academic, industries no realistic terms, definitions entries;
--- According to the actual technology, product development and clinical application of the progress, the original international standard text to the Doppler frequency of the main line of thinking
To the main line to the flow velocity;
--- An increase of some has been widely used in academic, industrial and clinical practice, the international standard texts were not included in the terms, definitions
entry;
--- Original reference to international standards, supplemented with the symbol table and technical specifications marked sections and some illustrative text.
This revised standard adopts IEC 61685.2001 "ultrasonic blood flow measuring blood flow phantom."
This standard and IEC 61685.2001 technical differences and the reasons are as follows.
--- In accordance with our practice, the original title of the standard three-stage structure to a "technical requirements for imitate Doppler blood flow phantom."
--- According to the US Institute of Ultrasound in Medicine (AIUM) and the definition of strict international standard IEC 61206.1993 in reference to the standard
Faithfully object called a "phantom."
Content --- original standard relates to methods of measuring the acoustic properties of the medium, the Department cited papers or short text to explain, but our country has developed
There are technical standards; normative references, some IEC standard had been converted to our standards, the situation above activities are changed
To refer to our standards. But imitation imitation blood and tissue material back scattering coefficient measurement method, internationally still under study, is not formed
A standardized document, it is still relevant reference works listed in the references.
--- Clutter clutter is medical ultrasound Doppler technology is a very important term appears more than once in the original standard has not given fixed
Meaning, especially to the income and were defined.
--- Original proposed standards identified by technical indicators, some content is still under study and explore, we can not put into practical use, leaving only the conversion
With existing international commodity random file on the same section.
--- Original standard Appendix D is the drafting of the research experiment content, total income and the necessity of not causing lengthy document, especially to Jane
Short text description, those interested can read the original.
Please note that some of the content of this document may involve patents. Release mechanism of the present 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. Acoustics, Chinese Academy of Sciences, the State Food and Drug Administration Medical Device Quality Supervision, Inspection and Hubei
center.
The main drafters of this standard. Cattle Fengqi, Zhu Chenggang, Cheng Yang, Jiang Shilin.
This standard was first released in June 2003.
Technical requirements for imitate blood flow Doppler phantoms
1 Scope
This standard specifies the technical requirements and methods of measurement of blood flow Doppler ultrasound phantom imitation.
This standard applies to the ultra ultrasound tissue mimicking material, embedded buried pipes and materials for steady state flow in the pipeline imitation blood composition
Acoustic Doppler blood flow phantom imitation (hereinafter referred to as imitation blood flow phantom), the device is mainly used for performance testing Doppler ultrasound diagnostic equipment and
Evaluation.
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 4472 chemical product density, relative density measurement General
GB/T 15261 ultrasound tissue mimicking material acoustic characteristics measurement method
GB/T 18022 Acoustics 1 ~ 10MHz methods of measurement in the frequency range of rubber and plastic longitudinal wave velocity and attenuation coefficient
YY/T 0704 pulsed Doppler ultrasound diagnostic system Performance test methods (IEC 61895.1999, IDT)
YY/T 0705 Test Method for CW Doppler ultrasound systems (IEC 61206.1993, IDT)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Attenuator attenuator
Doppler ultrasound diagnostic equipment performance measurements, placed between the ultrasonic probe and simulated blood flow phantom acoustic window for extended depth of
Range sound attenuation material sheet.
3.2
Pipeline average velocity averagevelocityintube
Imitation blood flow divided by the cross-sectional area of the pipeline provider.
Unit. m/s, m/s; cm/s, cm/s; mm/s, mm/s
3.3
The sampling area samplevolume
In the ultrasonic beam, so that the Doppler system to produce regional sports diffuser or reflector Doppler signal is located.
3.4
-3dB Sampling zone volume -3dBsamplevolume
Considering empty transmit and receive both the role of the Doppler system point target response generated higher than the maximum value of the response of -3dB
Between volumetric region.
Unit. cubic millimeters, mm3
3.5
-3dB Sampling zone length -3dBsamplevolumelength
The maximum size of the sampling area along -3dB beam collimation axis.
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