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YY/T 0108-2008 English PDF

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YY/T 0108-2008: Testing methods for M-mode of ultrasonic diagnostic equipment

YY/T 0108: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0108-2008English209 Add to Cart 3 days [Need to translate] Testing methods for M-mode of ultrasonic diagnostic equipment   YY/T 0108-2008
YY 0108-1993English599 Add to Cart 4 days [Need to translate] (M-mode pulse reflection ultrasound diagnostic equipment) Obsolete YY 0108-1993

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Basic data

Standard ID YY/T 0108-2008 (YY/T0108-2008)
Description (Translated English) Testing methods for M-mode of ultrasonic diagnostic equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C41
Classification of International Standard 11.040.50
Word Count Estimation 6,630
Date of Issue 2008-04-25
Date of Implementation 2009-06-01
Older Standard (superseded by this standard) YY 0108-1993
Quoted Standard GB/T 3947-1996; GB 10152-1997; GB/T 16540-1996; YY 0448-2003; YY/T 1142-2003
Regulation (derived from) SFDA [2008] No. 192
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the M-mode ultrasonic diagnostic equipment of terms and definitions, test conditions and test methods. This standard applies to the nominal frequency ultrasound in 2. 0 MHz ~ 15. 0 MHz range, with M-mode ultrasonic diagnostic equipment capabilities.

YY/T 0108-2008: Testing methods for M-mode of ultrasonic diagnostic equipment

---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.
Testing methods for M-mode of ultrasonic diagnostic equipment ICS 11.040.50 C41 People's Republic of China pharmaceutical industry standards Replacing YY 0108-1993 M mode ultrasound diagnostic equipment Test Method Posted 2008-04-25 2009-06-01 implementation State Food and Drug Administration issued

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. This standard by the National Standardization Technical Committee medical ultrasound equipment. Drafting of this standard. National medical ultrasound equipment Wuhan Quality Supervision and Inspection Center. The main drafters of this standard. Wang Zhijian, busy Ashmore. This standard replaces the standards previously issued as follows. --- WS2-304-1983; --- YY 0108-1993. M mode ultrasound diagnostic equipment Test Method

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 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 By the designer or manufacturer of a given ultrasonic transducer or ultrasonic transducer element group of ultrasonic frequency. 3.3 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 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 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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