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YY/T 0774-2019

Chinese Standard: 'YY/T 0774-2019'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0774-2019English209 Add to Cart Days<=3 Ultrasound bone sonometers Valid YY/T 0774-2019
YY/T 0774-2019Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 0774-2019 (YY/T0774-2019)
Description (Translated English) Ultrasound bone sonometers
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C41
Classification of International Standard 11.040.55
Word Count Estimation 10,170
Date of Issue 2019-07-24
Date of Implementation 2021-08-01
Drafting Organization Hubei Institute of Medical Device Quality Supervision and Inspection, Hefei University of Technology, Institute of Acoustics, Chinese Academy of Sciences, Liaoning Medical Device Inspection and Research Institute, Xianyang Kangrongxin Digital Ultrasound System Co., Ltd., Hubei Food and Drug Administration Technical Review and Verification Center
Administrative Organization National Medical Electrical Equipment Standardization Technical Committee Medical Ultrasound Equipment Subcommittee (SAC/TC 10/SC 2)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 0774-2019
Ultrasound bone sonometers
ICS 11.040.55
C41
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0774-2010
Ultrasound bone densitometer
Published on.2019-07-24
2021-08-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0774-2010 "ultrasonic bone densitometer". The main technical changes compared with YY 0774-2010 are as follows.
--- Modified the introduction;
--- Revised the scope of the standard (see Chapter 1, Chapter 1 of the.2010 edition);
---Modified the requirements and test methods for ultrasonic sound velocity (SOS) (see 4.2 and 5.3,.2010 editions 4.1.2 and 5.1.2);
---Modified the requirements for broadband ultrasonic attenuation (BUA) (see 4.3, version 4.1.3 of the.2010 edition);
--- Increased the test method for broadband ultrasonic attenuation (BUA) (see 5.4);
--- Removed the definition of T value, Z value (see.2010, 3.5, 3.6);
--- Removed the definition of the function confirmation program (see 3.8 of.2010 edition);
--- Removed the requirements for power supply voltage adaptability (see version 4.2 of.2010);
--- Removed the requirement for continuous working hours (see 4.3 of.2010 edition);
--- Removed the T-value and Z-value parts of the functional requirements (see 4.4.3 of the.2010 edition);
--- Removed the original Appendix A.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Medical Ultrasound Equipment Subcommittee (SAC/TC10/SC2).
This standard was drafted. Hubei Institute of Medical Device Quality Supervision and Inspection, Hefei University of Technology, Institute of Acoustics, Chinese Academy of Sciences, Liao
Ning Province Medical Device Inspection Institute, Xianyang Kangrongxin Digital Ultrasound System Co., Ltd., Hubei Food and Drug Administration Technical Review
Check the center.
The main drafters of this standard. Jiang Shilin, Wang Zhiwei, Huang Tao, Peng Hu, Niu Fengqi, Zhu Chenggang, Jiao Qiang, Du Wenyang, Ke Hu, Zheng Chichao,
Zhang Anping.
This standard replaces YY 0774-2010.
introduction
Ultrasound bone densitometer uses a special ultrasonic transducer to measure the amplitude of the attenuation through the (soft tissue and) bone, measuring the speed of sound and
Broadband ultrasound attenuation was calculated and the relevant parameters were calculated to evaluate bone density.
Ultrasound bone densitometer
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 bonemineraldensity
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 nominalacousticworkingfrequency
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/T 0774-2019
Ultrasound bone sonometers
ICS 11.040.55
C41
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0774-2010
Ultrasound bone densitometer
Published on.2019-07-24
2021-08-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0774-2010 "ultrasonic bone densitometer". The main technical changes compared with YY 0774-2010 are as follows.
--- Modified the introduction;
--- Revised the scope of the standard (see Chapter 1, Chapter 1 of the.2010 edition);
---Modified the requirements and test methods for ultrasonic sound velocity (SOS) (see 4.2 and 5.3,.2010 editions 4.1.2 and 5.1.2);
---Modified the requirements for broadband ultrasonic attenuation (BUA) (see 4.3, version 4.1.3 of the.2010 edition);
--- Increased the test method for broadband ultrasonic attenuation (BUA) (see 5.4);
--- Removed the definition of T value, Z value (see.2010, 3.5, 3.6);
--- Removed the definition of the function confirmation program (see 3.8 of.2010 edition);
--- Removed the requirements for power supply voltage adaptability (see version 4.2 of.2010);
--- Removed the requirement for continuous working hours (see 4.3 of.2010 edition);
--- Removed the T-value and Z-value parts of the functional requirements (see 4.4.3 of the.2010 edition);
--- Removed the original Appendix A.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Medical Ultrasound Equipment Subcommittee (SAC/TC10/SC2).
This standard was drafted. Hubei Institute of Medical Device Quality Supervision and Inspection, Hefei University of Technology, Institute of Acoustics, Chinese Academy of Sciences, Liao
Ning Province Medical Device Inspection Institute, Xianyang Kangrongxin Digital Ultrasound System Co., Ltd., Hubei Food and Drug Administration Technical Review
Check the center.
The main drafters of this standard. Jiang Shilin, Wang Zhiwei, Huang Tao, Peng Hu, Niu Fengqi, Zhu Chenggang, Jiao Qiang, Du Wenyang, Ke Hu, Zheng Chichao,
Zhang Anping.
This standard replaces YY 0774-2010.
introduction
Ultrasound bone densitometer uses a special ultrasonic transducer to measure the amplitude of the attenuation through the (soft tissue and) bone, measuring the speed of sound and
Broadband ultrasound attenuation was calculated and the relevant parameters were calculated to evaluate bone density.
Ultrasound bone densitometer
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 bonemineraldensity
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 nominalacousticworkingfrequency
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.
Related standard:   YY/T 0448-2019  YY/T 0449-2018
Related PDF sample:   YY 0766-2009  YY 0592-2016
   
 
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