YY/T 1466-2016 English PDF

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YY/T 1466-2016: Oral cavity X-ray equipment for digital tomography--Evaluation method for determination of bone mineral density
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1466-2016	179	Add to Cart	3 days	Oral cavity X-ray equipment for digital tomography--Evaluation method for determination of bone mineral density	Valid

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Basic data

Standard ID: YY/T 1466-2016 (YY/T1466-2016)
Description (Translated English): Oral cavity X-ray equipment for digital tomography--Evaluation method for determination of bone mineral density
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.50
Word Count Estimation: 9,911
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration

YY/T 1466-2016: Oral cavity X-ray equipment for digital tomography--Evaluation method for determination of bone mineral density

---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.
Oral cavity X-ray equipment for digital tomography - Evaluation method for determination of bone mineral density ICS 11.040.50 C43 People's Republic of China Pharmaceutical Industry Standard Oral X - ray digitized tomography equipment Evaluation of bone mineral density Evaluationmethodfordetermination ofbonemineraldensity 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Standardization Technical Committee of medical X-ray equipment and appliances standardized sub-technical committee (SAC/TC10 / SC1). The drafting of this standard. Liaoning Province Medical Device Inspection and Testing Institute, Northeastern University, the State Food and Drug Administration medical equipment technology Review center, Nanjing Pu love ray imaging equipment Limited. The main drafters of this standard. Sun Zhiyong, Wang Jianjun, Kang Yan, Peng Liang, Ruan Jian. Oral X - ray digitized tomography equipment Evaluation of bone mineral density

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 article Pieces. 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 bonemineraldensity (BMD) 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 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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