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YY/T 1417-2016Specifications of X-ray equipment for 64 slice helical computed tomography (English PDF)

64层螺旋X射线计算机体层摄影设备技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 1417-2016 is the English-translated version of 64层螺旋X射线计算机体层摄影设备技术条件.

YY/T 1417-2016 is the Chinese pharmaceutical industry standard for the 64-slice spiral X-ray computed tomography scanner.

It gives the terms and definitions, the classification, the composition, the requirements and the test methods, covering the spatial resolution in plane and along the axis, the low contrast detectability, the noise and the CT number accuracy and uniformity, the slice thickness and the geometric accuracy, the dose indices, the tube and generator, and the safety of the equipment. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 1417-2016

National Standard of the People's Republic of China

Classification: C 43

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 normative reference document
3 Terms and definitions
4 Composition
5 request
6 Test Method

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Normative references

GB 9706.11 · GB 9706.14 · GB 9706.18

Similar standards

YY/T 1625-2026|YY/T 0310-2025|YY/T 1766.3-2023|YY/T 1708.2-2020|YY/T 0829-2011|GB/T 19042.5-2022

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