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JJF 1649-2017Calibration Specification for Ultrasound Bone Sonometers (English PDF)

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Issued by

General Administration of Quality Supervision, Inspection and Quarantine

Level / Type

National · Mandatory

Issue date

November 20, 2017

Implementation date

February 20, 2018

Scope

JJF 1649-2017 (Calibration Specification for Ultrasound Bone Sonometers) is available as an English-translated PDF.

JJF 1649-2017 — This standard applies to the calibration of acoustic parameters of osteotomy and calcaneus type ultrasound bone densitometers.

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Document preview — JJF 1649-2017

National Standard of the People's Republic of China

ICS
17.140
Classification
A 59

Issued by: General Administration of Quality Supervision, Inspection and Quarantine

Contents

  • Introduction (II)
  • 1 Scope (1)
  • 2 References (1)
  • 3 Terms and units of measure (1)
  • 4 Overview (1)
  • 5 Metrological characteristics (2)
  • 5.1 Speed of sound (2)
  • 5.2 Sound Speed Measurement Repeatability (2)
  • 5.3 Wideband Ultrasonic Attenuation (2)
  • 6 Calibration Conditions (2)
  • 6.1 Environmental Conditions (2)
  • 6.2 Measurement Standards and Other Equipment (2)
  • 7 Calibration Items and Calibration Methods (2)
  • 7.1 Calibration Items (2)
  • 7.2 Calibration Methods (3)
  • 8 Expression of Calibration Results (5)
  • 8.1 Calibration Record (5)
  • 8.2 Calibration Certificate (5)
  • 8.3 Measurement uncertainty of calibration results (5)
  • 9 Re-school interval (5)
  • Appendix A Ultrasonic Bone Density Test Module (6)
  • Appendix B Content and Inner Page Format of Calibration Certificate for Ultrasonic Bone Densitometer (7)
  • Appendix C Example of Uncertainty Assessment (8)

1 Scope (1)

2 References (1)

3 Terms and units of measure (1)

4 Overview (1)

5 Metrological characteristics (2)

5.1 Speed of sound (2)

5.2 Sound Speed Measurement Repeatability (2)

5.3 Wideband Ultrasonic Attenuation (2)

6 Calibration Conditions (2)

6.1 Environmental Conditions (2)

6.2 Measurement Standards and Other Equipment (2)

7 Calibration Items and Calibration Methods (2)

7.1 Calibration Items (2)

7.2 Calibration Methods (3)

8 Expression of Calibration Results (5)

8.1 Calibration Record (5)

8.2 Calibration Certificate (5)

8.3 Measurement uncertainty of calibration results (5)

9 Re-school interval (5)

Appendix A Ultrasonic Bone Density Test Module (6)

Appendix B Content and Inner Page Format of Calibration Certificate for Ultrasonic Bone Densitometer (7)

Appendix C Example of Uncertainty Assessment (8)

Introduction

This specification is based on JJF 1071-2010 "Rules for the preparation of national measurement calibration rules" and JJF 1059.1-2012 the formulation of rules and formats given in Assessment and Expression of Measurement Uncertainty.

This specification mainly refers to the YY 0774-2010 "ultrasonic bone density meter", YY/T 0939-2014 "ultrasonic bone Densitometer Broadband Ultrasound Attenuation (BUA) Test Method." this specification is the first release.

Ultrasound Bone Densitometer Calibration Specification

1 Scope

This specification applies to the calibration of acoustic parameters of tibial and calcaneus-type ultrasound bone densitometers.

2 references

This specification refers to the following documents.

JJF 1001-2011 Universal Measurement Terms and Definitions JJF 1034-2005 Acoustic Measurement Terms Terms and Definitions GB 3102.7-1993 Acoustic quantities and units GB/T 3947-1996 Acoustic terms YY0774-2010 Ultrasound Bone Densitometer YY/T 0939-2014 Ultrasound Bone Densitometer Broadband Ultrasound Attenuation (BUA) Test Method for dated references, only dated editions apply to this specification; all undated references the latest version (including all amendments) applies to this specification.

3 Terms and units of measure the definitions of JJF 1001-2011, JJF 1034-2005, YY0774-2010 and GB/T 3947-1996 the following terms and definitions apply to this specification.

This specification uses the amount and unit specified in GB 3102.7-1993.

3.1 Bone mineral density Mineral density in bone (abbreviated as bone density), which is the volume of mineral in a unit volume of bone.

Symbol. rhob, unit. mg/cm3 [YY0774-2010, Definition 3.1]

3.2 Sound speed speedofsound the speed at which sound waves travel in the medium.

Symbol. c, unit. m/s [GB/T 3947-1996, definition 2.17]

3.3 Broadband Ultrasound Attenuation (BUA) in a wider frequency band, the ultrasonic attenuation of the ultrasonic wave through the medium is related to the slope of the frequency.

Symbol. BUA, Unit. dB/MHz [YY0774-2010 Definition 3.4]

4 Overview

The ultrasonic bone densitometer is based on the speed of ultrasound propagation in bone tissue and the degree of broadband ultrasound attenuation.

Non-invasive and non-radioactive medical measuring instruments for measuring physiological parameters such as bone density and bone strength.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 9 pages — is available in the English PDF.

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