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YY 0774-2010Ultrasound bone sonometers (English PDF)

超声骨密度仪

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 27, 2010

Implementation date

June 1, 2012

Scope

YY 0774-2010 is the English-translated version of 超声骨密度仪.

YY 0774-2010 is the Chinese standard "Ultrasound bone sonometers". Its scope clause reads: This standard specifies the terms and definitions, requirements and test methods for ultrasonic bone densitometers.

This standard applies to the use of ultrasound principles, by measuring the speed of sound and attenuation characteristics in the bone to evaluate the bone quality of the human body. Instrument. Its clauses include terms and definitions.

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Document preview — YY 0774-2010

National Standard of the People's Republic of China

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

Contents

  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 3.1 Bone minerality
  • 3.2 Nominal working frequency
  • 3.3 Acoustic operating frequency

1 Scope

This standard specifies the terms and definitions, requirements and test methods for ultrasonic bone densitometers.

This standard applies to the use of ultrasound principles, by measuring the speed of sound and attenuation characteristics in the bone to evaluate the bone quality of the human body.

Instrument.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.

Pieces. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.9 Medical electrical equipment - Part 2-37. Particular requirements for safety of medical ultrasound diagnostic and monitoring equipment

GB/T 14710-2009 Environmental requirements and test methods for medical appliances

GB/T 15261-2008 Method for measuring acoustic properties of ultrasonic-like tissue materials

JJF1001 General Measurement Terms and Definitions

YY/T 0865.1 Ultrasonic hydrophones Part 1. Measurement and characterization of medical ultrasound fields below 40 MHz

YY/T 0939 Ultrasonic Bone Densitometer Broadband Ultrasonic Attenuation (BUA) Test Method

YY/T 1142 Medical Ultrasound Equipment and Probe Frequency Characteristics Test Method

YY/T 1420 Medical Ultrasound Equipment Environmental Requirements and Test Methods

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Bone minerality

The density of minerals in the bone, ie the amount of minerals per unit volume of bone. The bone density in this standard is evaluated by ultrasound parameters.

The unit is milligrams per cubic centimeter (mg/cm3).

Note. Usually referred to as BMD.

3.2 Nominal working frequency

Ultrasonic operating frequency published by the designer or manufacturer.

The unit is megahertz (MHz).

3.3 Acoustic operating frequency

The arithmetic mean of the corresponding frequencies at 3 dB below the peak in the sound pressure spectrum.

The unit is megahertz (MHz).

Note. Rewrite YY/T 0865.1, 3.3.

YY 0789-2024 | YY/T 0767-2023 | YY 0844-2011 | YY/T 0773-2023 | […]

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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.

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