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YY/T 0724-2021 | English | 409 |
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Particular specifications for dual-energy X-ray absorptiometry
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YY/T 0724-2021
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YY/T 0724-2009 | English | 679 |
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Particular specifications for dual energy X-ray bone densitometer
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YY/T 0724-2009
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PDF similar to YY/T 0724-2021
Basic data Standard ID | YY/T 0724-2021 (YY/T0724-2021) | Description (Translated English) | Particular specifications for dual-energy X-ray absorptiometry | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C43 | Word Count Estimation | 22,218 | Issuing agency(ies) | State Drug Administration |
YY/T 0724-2021: Particular specifications for dual-energy X-ray absorptiometry---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.
Particular specifications for dual-energy X-ray absorptiometry
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standards
Replace YY/T 0724-2009
Special technical conditions for dual-energy X-ray bone densitometer
Released on 2021-03-09
2022-04-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Classification and composition 2
5 Requirements 2
5.1 Working conditions 2
5.2 Electric power 3
5.3 Loading factors and control 3
5.4 X-ray irradiation 3
5.5 Detector 4
5.6 Bone density measurement 4
5.7 Frame and/or supporting device 7
5.8 Report output and software functions 7
5.9 Noise 8
5.10 Appearance 8
5.11 Environmental test 8
5.12 Security 8
6 Test method 8
6.1 Working conditions 8
6.2 Electric power 8
6.3 Loading factors and control 8
6.4 X-ray irradiation 10
6.5 Detector 10
6.6 Bone density measurement 10
6.7 Frame and/or supporting device 12
6.8 Report output and software functions 13
6.9 Noise 13
6.10 Appearance 13
6.11 Environmental test 13
6.12 Security 13
Appendix A (informative appendix) Test phantom 14
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0724-2009 "Special technical conditions for dual-energy X-ray bone densitometer". Corresponding to YY/T 0724-2009
Compared with the editorial changes, the main technical changes are as follows.
---Modified the classification (see 4.1, 4.1 in the.2009 edition);
---Modified the composition (see 4.2, 4.2 of the.2009 edition);
---Modified X-ray irradiation (see 5.4, 5.8 in the.2009 edition);
---Added a detector;
--- Modify the bone density measurement (see 5.6, 5.4 in the.2009 edition);
---Modified the frame and/or supporting device (see 5.7, 5.5 of the.2009 edition);
---Modified report output and software functions (see 5.8, 5.6 of the.2009 edition);
---Modified the appearance (see 5.10, 5.9 of the.2009 edition);
---Modified the security (see 5.12, 5.11 of the.2009 edition);
---Modified the test method of X-ray irradiation (see 6.4, 6.8 in.2009 edition);
---The test method of the detector has been added (see 6.5);
---Modified the test method of bone density measurement (see 6.6, 6.4 of the.2009 edition);
---Modified the test method of the frame and/or supporting device (see 6.7, 6.5 of the.2009 edition);
---Modified the test method of report output and software function (see 6.8, 6.6 of the.2009 edition);
---Modified the test method of appearance (see 6.10, 6.9 of the.2009 edition);
---Modified the test phantom (see Appendix A, Appendix A of the.2009 edition);
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical X-ray Equipment and Appliance Sub-Technical Committee (SAC/TC10/SC1)
Focus.
Drafting organizations of this standard. Liaoning Provincial Institute of Medical Device Inspection and Testing, Medical Device Technical Evaluation Center of the State Drug Administration, Beijing
Jishuitan Hospital, Beijing General Electric Hualun Medical Equipment Co., Ltd., Haolojie Medical Technology (Beijing) Co., Ltd., Hitachi Medical (Guangzhou)
Co., Ltd., Xuzhou Pinyuan Electronic Technology Co., Ltd.
The main drafters of this standard. Jin Yubo, Zhang Yujing, Zheng Chen, Cheng Xiaoguang, Wang Xinying, Su Xihong, Wang Li, Ji Bolun.
The previous versions of the standard replaced by this standard are as follows.
---YY/T 0724-2009.
Special technical conditions for dual-energy X-ray bone densitometer
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements and tests of dual-energy X-ray bone densitometers (hereinafter referred to as bone densitometers)
method.
This standard applies to bone densitometers based on the dual-energy X-ray absorption method. This product is mainly used to measure the bone density of human bones
Measurement and analysis. This standard does not apply to X-ray computed tomography equipment (CT machine) for bone density measurement devices.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB 7247.1 Safety of Laser Products Part 1.Equipment Classification and Requirements
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Safety
GB 9706.11 Medical electrical equipment Part 2.Special requirements for the safety of medical diagnostic X-ray source components and X-ray tube components
GB 9706.12 Medical electrical equipment Part 1.General safety requirements III. Parallel standards for radiation protection of diagnostic X-ray equipment
common enquiries
GB 9706.14 Medical electrical equipment Part 2.Special requirements for the safety of auxiliary equipment of X-ray equipment
GB/T 10149 Terms and Symbols for Medical X-ray Equipment
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard. Electromagnetic Compatibility Requirements and Tests
3 Terms and definitions
The following terms and definitions defined in GB/T 10149 apply to this document.
3.1
Targetobject
The part of the bone to be measured.
3.2
Bone area bonearea
The projected area of the target on a plane perpendicular to the reference axis
Note. The unit is cm2.
3.3
Bonemineralcontent
The quality of the inorganic matter in the target.
Note. The unit is g.
3.4
Bonemineraldensity
Bone density
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