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Calibration Specification for Ultrasound Bone Sonometers
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JJF 1649-2017
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Basic data Standard ID | JJF 1649-2017 (JJF1649-2017) | Description (Translated English) | Calibration Specification for Ultrasound Bone Sonometers | Sector / Industry | Metrology & Measurement Industry Standard | Classification of Chinese Standard | A59 | Classification of International Standard | 17.140 | Word Count Estimation | 14,118 | Date of Issue | 2017-11-20 | Date of Implementation | 2018-02-20 | Quoted Standard | JJF 1001-2011; JJF 1034-2005; GB 3102.7-1993; GB/T 3947-1996; YY 0774-2010; YY/T 0939-2014 | Regulation (derived from) | AQSIQ Notice 2017 No. 103 | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine | Summary | This standard applies to the calibration of acoustic parameters of osteotomy and calcaneus type ultrasound bone densitometers. |
JJF 1649-2017: Calibration Specification for Ultrasound Bone Sonometers---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.
(Ultrasound bone density meter calibration specification)
People's Republic of China National Metrology Technical Specifications
Ultrasound Bone Densitometer Calibration Specification
Published on.2017-11-20
2018-02-20 Implementation
The State Administration of Quality Supervision, Inspection and Quarantine issued
Ultrasound Bone Densitometer Calibration Specification
Integral Unit. National Acoustic Measurement Technical Committee
The main drafting unit. Shenyang Measurement and Testing Institute
Participated in the drafting unit. Liaoning Province Medical Device Inspection and Testing Institute
Beijing Yueqi Chuangtong Technology Co., Ltd.
Funuo Technology (Dalian) Co., Ltd.
Austro Medical Devices (Shanghai) Co., Ltd.
This specification entrusts the National Acoustic Measurement Technical Committee to explain
The main drafters of this specification.
Huang Jinfeng (Shenyang Measurement & Testing Institute)
Zhang Gong (Shenyang Metrology and Measurement Institute)
Zhang Yuhong (Shenyang Measurement and Testing Institute)
Participating drafters.
Strengthened (Liaoning Provincial Medical Device Inspection and Testing Institute)
Qi Minchao (Beijing Yueqi Chuangtong Technology Co., Ltd.)
Fang Min [Funuo Technology (Dalian) Co., Ltd.]
Li Jianwei [Austau Medical Devices (Shanghai) Co., Ltd.]
table of 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)
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. ρb, 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 broadbandultrasoundattenuation (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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