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YY/T 0458-2014Technical requirements for ultrasonically blood-mimicking Doppler phantom (English PDF)

超声多普勒仿血流体模的技术要求

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 0458-2014 is the English-translated version of 超声多普勒仿血流体模的技术要求.

YY/T 0458-2014 is the Chinese pharmaceutical industry standard that sets the technical requirements and the measurement methods for the ultrasonic blood-mimicking Doppler phantom.

It applies to phantoms made of tissue-mimicking material with tubes embedded in it through which a blood-mimicking fluid flows steadily, and it covers the acoustic properties of the material and of the fluid, the geometry of the tubes, the flow and its stability, and the way the Doppler performance of an ultrasound system is measured with the phantom. Issued on 17 June 2014, it has applied since 1 July 2015.

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Document preview — YY/T 0458-2014

National Standard of the People's Republic of China

ICS
17.140.50
Classification
C 41
Replacing
YY/T 0458-2003

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Preface
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Symbol Table
  • 5 imitation blood flow phantom outline
  • 6 imitation blood flow phantom technical requirements
  • 7 measures to prevent fake blood components to modify and eliminate air bubbles
  • 8 9 Technical specifications identify the content Measurement Method 9 simulated blood flow phantom main technical parameters of
  • Appendix B (normative) contact each amount of formula
  • Annex C (informative) Description of the standard value of 15 selected
  • Annex D (informative) Imitation body flow Doppler pattern product test
  • Annex E (informative) Doppler phantoms and simulated blood flow control system diagram
  • References

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.

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

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

Imitation blood flow divided by the cross-sectional area of the pipeline provider. Unit.

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

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.

3.5 -3dB Sampling zone length

The maximum size of the sampling area along -3dB beam collimation axis.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

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Editions of YY/T 0458

EditionTitleRevisionStatus
YY/T 0458-2014Technical requirements for ultrasonically blood-mimicking Doppler phantomcurrent editionCurrent
YY/T 0458-2003Technical requirements for ultrasonically blood-mimicking Doppler phantomprevious editionSuperseded

This page sells the current edition, YY/T 0458-2014. Earlier editions are listed for reference only.

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