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YY/T 0707-2020 PDF English

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YY/T 0707-2020: Particular specifications for mobile radiography X-ray equipment
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YY/T 0707: Historical versions

Std IDVersionUSDBuyDeliver [PDF] inTitle (Description)
YY/T 0707-2020English299 Add to Cart 4 days [Need to translate] Particular specifications for mobile radiography X-ray equipment
YY/T 0707-2008English319 Add to Cart 3 days [Need to translate] Particular specifications for mobile radiography X-ray equipment

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Basic data

Standard ID YY/T 0707-2020 (YY/T0707-2020)
Description (Translated English) Particular specifications for mobile radiography X-ray equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 16,122
Date of Issue 2020-09-27
Date of Implementation 2021-09-01
Older Standard (superseded by this standard) YY/T 0707-2008
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies) State Drug Administration

YY/T 0707-2020: Particular specifications for mobile radiography X-ray equipment


---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.
(Special technical requirements for mobile X-ray machine) ICS 11:040:50 C43 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 0707-2008 Special technical requirements for mobile X-ray machine 2020-09-27 release 2021-09-01 implementation Issued by the State Drug Administration

Table of contents

Preface Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Classification and composition 1 5 Requirements 2 6 Test method 6 Appendix A (informative appendix) Test body membrane 11

Foreword

This standard was drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY/T 0707-2008 "Special technical requirements for mobile X-ray machines:" Compared with YY/T 0707-2008, the main technical changes of this standard are as follows: --- Modify the "scope" (see Chapter 1, Chapter 1 of the:2008 edition); ---Modified the "normative references" (see Chapter 2, Chapter 2 of the:2008 edition); ---Modified "Terms and Definitions" (see Chapter 3, Chapter 3 of the:2008 edition); --- Revised "Classification and Composition" (see Chapter 4, Chapter 4 of the:2008 edition); --- Deleted "Internal power supply: specified by product standards" (see 5:1:2e of the:2008 edition)); ---Modified the "maximum output electric power" requirements and test methods (see 5:2:1 and 6:2:1, 5:2:1 and 6:2:1 of the:2008 edition); ---Modified "nominal electric power" requirements and test methods (see 5:2:2 and 6:2:2, 5:2:2 and 6:2:2 of the:2008 edition); ---Modified "X-ray tube voltage" requirements and test methods (see 5:3:1 and 6:3:1, 5:3:1 and 6:3:1 of the:2008 edition); ---Modified "X-ray tube current" requirements and test methods (see 5:3:2 and 6:3:2, 5:3:2 and 6:3:2 of the:2008 edition); ---Modified the "loading time" requirements and test methods (see 5:3:3 and 6:3:3, 5:3:3 and 6:3:3 of the:2008 edition); ---Modified "current time product" requirements and test methods (see 5:3:4 and 6:3:4, 5:3:4 and 6:3:4 of the:2008 edition); ---Modified the "imaging performance" requirements and test methods (see title 5:4, 5:4:1, 5:4:2, 5:4:3, 5:4:4, 5:4:5, 5:4:6, 5:4:7, 5:4:8, 5:4:9, 5:4:10, 5:4:1, 5:4:2 of the:2008 edition; 6:4:1, 6:4:2, 6:4:3, 6:4:4, 6:4:5, 6:4:6, 6:4:7 , 6:4:8, 6:4:9, 6:4:10,:2008 version 6:4:1, 6:4:2 test method); ---Modified the requirements and test methods of "mechanical motion range" (see 5:5:1 and 6:5:1, 5:5:1 and 6:5:1 of the:2008 edition); ---Modified the "angle indication value" requirements and test methods (see 5:5:3 and 6:5:3, 5:5:3 and 6:5:3 of the:2008 edition); ---Modified the "mobile performance" requirements and test methods (see 5:5:5 and 6:5:5, 5:5:5 and 6:5:5 of the:2008 edition); ---Added "movement across the threshold" requirements and test methods (see 5:5:6 and 6:5:6); ---Added "instability in non-transportation state" requirements and test methods (see 5:5:7 and 6:5:7); ---Added "instability in transportation" requirements and test methods (see 5:5:8 and 6:5:8); ---Added "unexpected movement" requirements and test methods (see 5:5:9 and 6:5:9); ---Added the requirements and test methods of "Outer Dimensions in Moving State" (see 5:5:10 and 6:5:10); ---Added the requirements and test methods of "detector falling" (see 5:5:11 and 6:5:11); ---Added the requirements and test methods of "detector load" (see 5:5:12 and 6:5:12); ---Modified "noise" requirements and test methods (see 5:6 and 6:6,:2008 edition of 5:6 and 6:6); ---Modified the "internal power supply" requirements and test methods (see 5:7 and 6:7, the:2008 edition of 5:7 and 6:7); --- Deleted the "moving state dimensions" (5:8 in the:2008 version); ---Added "exposure control device" requirements and test methods (see 5:8 and 6:8); ---Modified the requirements and test methods of "high-voltage cable plugs and sockets" (see 5:9 and 6:9, 5:9 and 6:9 in the:2008 edition); ---Added "software" requirements and test methods (see 5:10 and 6:10); ---Modified the "appearance" requirements and test methods (see 5:11 and 6:11, 5:10 and 6:10 of the:2008 edition); ---Modified the "safety requirements" requirements and test methods (see 5:13 and 6:13,:2008 edition 5:12 and 6:12); ---Modified the "power conditions" (see 6:1:2, 6:1:2 of the:2008 edition); --- Added "Linearity Test Card" (see Appendix A): Please note that certain 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 Standardization Sub-Technical Committee (SAC/TC10/ SC1) Centralized: Drafting organizations of this standard: Liaoning Medical Device Inspection and Testing Institute, Neusoft Medical System Co:, Ltd:, Shanghai United Imaging Medical Technology Co:, Ltd: Co:, Ltd:, Chengdu Yilexin Biotechnology Co:, Ltd:, Shanghai Bofang Medical Technology Co:, Ltd: The main drafters of this standard: Shan Xu, Liang Tiecheng, Ren Tao, Meng Zhaoyang, Fan Bo, Feng Qingyu, Liu Jingbo: The previous releases of this standard instead of the standard are as follows: ---YY/T 0707-2008: Special technical requirements for mobile X-ray machine

1 Scope

This standard specifies the terms and definitions, classification and composition, requirements and tests of mobile X-ray machines (hereinafter referred to as X-ray machines) method: This standard only applies to mobile X-ray machines powered by single-phase AC power and/or internal power sources:

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 references, the latest version (including all amendments) applies to this document: GB 9706:1 Medical Electrical Equipment Part 1: General Requirements for Safety GB 9706:3 Medical electrical equipment Part 2: Special requirements for the safety of high-voltage generators for diagnostic X-ray generators 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 Standard: Radiation Protection of Diagnostic X-ray Equipment common enquiries GB 9706:14 Medical electrical equipment Part 2: Special requirements for the safety of X-ray equipment accessory equipment GB/T 10149 Medical X-ray equipment terms and symbols GB/T 10151 Technical conditions for high-voltage cable plugs and sockets for medical diagnostic 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 YY/T 0590:1-2018 Characteristics of digital X-ray imaging devices for medical electrical equipment Part 1-1: Quantum detection efficiency Detector for general photography YY/T 0741 Special technical conditions for digital photography X-ray machines YY/T 0933-2014 Digital X-ray image detector for general medical photography

3 Terms and definitions

The terms and definitions defined in GB 9706:1, GB/T 10149 and YY/T 0741 apply to this document:

4 Classification and composition

4:1 Classification According to the form of image formation, it can be divided into screen type and digital type: 4:2 Composition The X-ray machine should have at least the following main components: a) X-ray generator; b) Mobile machinery; ...

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