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YY/T 0707-2020Particular specifications for mobile radiography X-ray equipment (English PDF)

移动式摄影X射线机专用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 27, 2020

Implementation date

September 1, 2021

Scope

YY/T 0707-2020 is the English-translated version of 移动式摄影X射线机专用技术条件.

YY/T 0707-2020 is the Chinese pharmaceutical industry standard for mobile radiographic X-ray machines, the units wheeled to the patient's bedside.

It gives the terms and definitions, the classification and composition of the equipment, the requirements and the test methods, covering the accuracy and reproducibility of the loading factors, the radiation output and the beam limitation, the leakage radiation and the protection of the operator, the mechanical stability and braking of the machine when moved, the battery where an internal source is used, and the accompanying documents.

It applies to mobile machines supplied from single-phase mains or from an internal source. Issued on 27 September 2020, it has applied since 1 September 2021.

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Document preview — YY/T 0707-2020

National Standard of the People's Republic of China

ICS
11.040.50
Classification
C 43
Replacing
YY/T 0707-2008

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

Contents

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

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.

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 document. 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;

......
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

Similar standards

Editions of YY/T 0707

EditionTitleRevisionStatus
YY/T 0707-2020Particular specifications for mobile radiography X-ray equipmentcurrent editionCurrent
YY/T 0707-2008Particular specifications for mobile radiography X-ray equipmentprevious editionSuperseded

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