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YY/T 0108-2008Testing methods for M-mode of ultrasonic diagnostic equipment (English PDF)

超声诊断设备M模式试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

April 25, 2008

Implementation date

December 1, 2009

Scope

YY/T 0108-2008 is the English-translated version of 超声诊断设备M模式试验方法.

YY/T 0108-2008 is the Chinese test-method standard for the M-mode function of ultrasound diagnostic equipment. It defines the terms involved, including M-mode, nominal frequency, axial and lateral resolution and detection depth, fixes the test conditions and describes how each parameter is measured with a test phantom.

Compared with the earlier product standard it adds distance display error and time display error, and drops comprehensive sensitivity, scan linearity and dead zone; none of the tests requires opening the equipment or rewiring its circuits.

It applies to diagnostic ultrasound equipment with an M-mode function and a nominal frequency from 2.0 MHz to 15.0 MHz. It replaces YY 0108-1993, was issued on 25 April 2008 and has applied since 1 December 2009.

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Document preview — YY/T 0108-2008

National Standard of the People's Republic of China

ICS
11.040.50
Classification
C 41
Replacing
YY 0108-1993

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions

Foreword

This standard replaces YY 0108-1993 "M-mode pulse reflection ultrasound diagnostic equipment." This standard YY 0108-1993 compared to major changes are as follows.

--- YY 0108-1993 mandatory product standards, the new revised standard is the recommended test method standards;

--- Deleted all references to the technical content of product standards, including environmental testing requirements, safety requirements, appearance requirements;

--- Remove the "inspection rules" chapter;

--- Deleted "logo, packaging, transportation and storage" chapter;

--- Increase the Chapter 4, "test conditions";

--- Part in the pilot project, delete the words "comprehensive sensitivity", "linear scan", "detection blind spots" three indicators, an increase of "distance display Error "and" Show time error "two indicators;

--- In the Test Methods section, delete all test methods involve open the device under test, reconnect the circuit under test. Using not split Machines, test method does not re-wiring.

1 Scope

This standard specifies the terms and definitions, test conditions and test methods for ultrasound diagnostic equipment M mode.

This standard applies to nominal frequency ultrasound in the range of 2.0MHz ~ 15.0MHz, with M-mode function of ultrasound diagnostic equipment.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB/T 3947-1996 Acoustics Terminology

GB 10152-1997 B-type ultrasonic diagnostic equipment

GB/T 16540-1996 acoustic characterization of ultrasonic fields in the frequency range 0.5 ~ 15MHz and its measurement method hydrophone (Eqv IEC 61102:1991)

YY 0448-2003 Doppler fetal heart rate meter (IEC 61226:1994, MOD)

Test Method YY/T 1142-2003 ultrasonic medical diagnostic and monitoring equipment frequency characteristics

3 Terms and Definitions

GB/T 3947-1996, GB/T 16540-1996 and established the following terms and definitions apply to this standard.

3.1 M-mode

One kind of echo amplitude with a modulation intensity pattern, the ordinate represents the tissue depth on the screen, the abscissa represents time, represents the luminance of the echo.

Strength. Currently M mode function basic combination of B-type ultrasonic diagnostic apparatus.

3.2 Nominal frequency

By the designer or manufacturer of a given ultrasonic transducer or ultrasonic transducer element group of ultrasonic frequency.

3.3 Axial resolution

Scanning along the center line, at a predetermined depth in the test phantom, showing two lines between two target echo signal distinguishable minimum spacing. Units. millimeters (mm).

3.4 Lateral resolution

At a predetermined depth in the test phantom, the scanning line perpendicular to the center line of the target, the minimum width in the scanning plane is displayed. Units. millimeters (mm).

3.5 Detection depth

When the test is capable of displaying phantom target longitudinal line group deepest target line image, the corresponding depth. Units. millimeters (mm).

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY/T 0108

EditionTitleRevisionStatus
YY/T 0108-2008Testing methods for M-mode of ultrasonic diagnostic equipmentcurrent editionCurrent
YY 0108-1993Testing methods for M-mode of ultrasonic diagnostic equipmentprevious editionSuperseded

This page sells the current edition, YY/T 0108-2008. Earlier editions are listed for reference only.

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