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YY/T 1417-2016 English PDF

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YY/T 1417-2016: Specifications of X-ray equipment for 64 slice helical computed tomography
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1417-2016	English	219	Add to Cart	3 days [Need to translate]	Specifications of X-ray equipment for 64 slice helical computed tomography	Valid	YY/T 1417-2016

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Basic data

Standard ID	YY/T 1417-2016 (YY/T1417-2016)
Description (Translated English)	Specifications of X-ray equipment for 64 slice helical computed tomography
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C43
Word Count Estimation	11,128
Date of Issue	2016-07-29
Date of Implementation	2017-06-01
Regulation (derived from)	State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies)	State Food and Drug Administration

YY/T 1417-2016: Specifications of X-ray equipment for 64 slice helical computed tomography

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Specifications of X-ray equipment for 64 slice helical computed tomography ICS 11.40.50 C43 People's Republic of China Pharmaceutical Industry Standard 64 - slice spiral X - ray computed tomography Equipment technical conditions 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Composition 1 5 request 2 6 Test Method 5

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 Apparatus Standardization Technical Committee of medical X-ray equipment and appliances standardized sub-technical committee (SAC/TC10/SC1). The drafting of this standard. Liaoning Medical Devices Laboratory, Shenyang Neusoft Medical System Co., Ltd., Shanghai Siemens Medical Devices Limited the company. The main drafters of this standard. Liu Jingbo, by Hong Shun, Yang Yitao, Wang Jianjun, Hou Yaofang, Shan Xu, Meng Zhaoyang, Wang Lixin. 64 - slice spiral X - ray computed tomography Equipment technical conditions

1 Scope

This standard specifies the terminology and definition of a 64-layer spiral X-ray computed tomography apparatus (hereinafter referred to as a 64-layer CT scanning device) Meaning, classification, composition, requirements and test methods. This standard applies to 64-layer CT scanning devices.

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. Medical electrical equipment - Part 1. General requirements for safety GB 9706.1 GB 9706.11 Medical electrical equipment - Part 2. Particular requirements for the safety of medical diagnostic X - ray source assemblies and X - ray tube assemblies GB 9706.12 Medical electrical equipment - Part 1. General requirements for safety III. Parallel standard diagnostic X - ray equipment Radiation protection pass With the request GB 9706.14 Medical electrical equipment - Part 2. Particular requirements for the safety of ancillary equipment for X - ray equipment GB 9706.15 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety requirements GB 9706.18 Medical electrical equipment - Part 2. Particular requirements for the safety of X - ray computed tomography equipment GB/T 10149 Medical X - ray equipment - Terms and symbols GB/T 10151 Medical diagnostic X - ray equipment High - voltage cable plugs and sockets Technical conditions GB/T 19042.5-2006 Evaluation and routine testing of medical imaging departments - Part 3-5. X-ray computed tomography Ready performance acceptance test Technical specification for coating classification of metal parts YY 0076-1992 Medical environmental requirements and test methods for medical X - ray equipment YY/T 0291-2016 General technical requirements for X - ray computed tomography equipment YY/T 0310-2015 YY 0505 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests Safety Requirements for Radiotherapy Planning System for Medical Electrical Equipment YY 0637

3 terms and definitions

GB/T 10149, GB 9706.18, GB/T 19042.5 and YY 0637 and the following terms and definitions apply to this document. 3.1 64-slice spiral X-ray computed tomography equipment X-rayequipmentfor64slicehelicalcomputedtomography The number of image layers obtained when the X-ray source is rotated by 360 ° is 64 layers and has a helical scan function and whose detectors are in 32 rows and above X - ray computed tomography equipment.

4 composition

The 64-slice CT scanning device consists of the following components.

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