YY/T 1466-2016Oral cavity X-ray equipment for digital tomography—Evaluation method for determination of bone mineral density (English PDF)
口腔X射线数字化体层摄影设备骨密度测定评价方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1466-2016 is the English-translated version of 口腔X射线数字化体层摄影设备骨密度测定评价方法.
YY/T 1466-2016 is the Chinese pharmaceutical industry standard that gives the method for evaluating the determination of maxillary bone mineral density by oral X-ray digital tomography equipment used under the conditions the manufacturer states.
It applies to equipment for which the manufacturer claims a bone density measurement, and it is addressed to manufacturers, hospitals and test laboratories, setting out the phantom, the acquisition and the measurement, the accuracy and the reproducibility of the value obtained and the way the result is reported. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1466-2016
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C 43
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
- 4 Working conditions
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the oral X-ray digital tomography equipment in the manufacturer under the conditions of medical use, the maxillary bone density Determination of the evaluation method. The intended users of this standard are manufacturers, hospitals and test laboratories.
This standard applies to oral X-ray digital tomography equipment that the manufacturer claims to have bone density measurements.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 10149 Medical X - ray equipment - Terms and symbols Special technical conditions for oral X - ray digital tomography equipment YY/T 0795
3 Terms and definitions
GB/T 10149 and YY/T 0795, as well as the following terms and definitions, apply to this document.
3.1 Bone mineral density
Bone mineral content per unit bone volume (unit. mg/cm3).
3.2 Repeatability
The same measured object under the same scanning conditions to scan multiple changes in bone mineral density measurements.
3.3 Correlation
A series of bone mineral density markers and their correlation with bone mineral density measurements.
3.4 Selection dependent dependence
The same measured object in the same scan of different fault bone mineral density measurements of variation.
4 Working conditions
Oral X-ray digital tomography equipment should be stored and used under the conditions suggested by the manufacturer and maintained during the inspection process stable.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 10149-1988 — Terminology and symbol for medical X-ray equipment
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