YY/T 0742-2021Particular specifications for gastrointestinal diagnostic X-ray equipment (English PDF)

Foreword

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

This standard replaces YY/T 0742-2009 "Special technical conditions for gastrointestinal X-ray machines", compared with YY/T 0742-2009, except for editing In addition to the modification, the main technical changes are as follows.

---Modified the scope (see Chapter 1,.2009 edition);

---Modified the normative reference documents (see Chapter 2, Chapter 2 of the.2009 edition);

---Modified the terms and definitions "perspective image brightness stability" and "perspective image stabilization time" (see 3.2, 3.1,.2009 edition 3.1, 3.2);

---Added terms and definitions "preparation time for point-and-shoot photography" (see 3.3);

---Modified the classification and composition (see Chapter 4, Chapter 4 of the.2009 edition);

---Modified loading factors and control (see 5.3 and 6.3, 5.3 and 6.3 of the.2009 edition);

---Modified the imaging performance of indirect X-ray fluoroscopy and indirect X-ray photography (see 5.4 and 6.4, the.2009 edition of 5.4.2, 5.4.3, 6.4.2 and 6.4.3);

--- Increased radiation safety (see 5.5, 6.5);

---Modified the weight bearing of the gastrointestinal diagnostic bed (see 5.6.10 and 6.6.10, 5.5 and 6.5 in the.2009 edition);

---Added accompanying documents (see 5.8, 6.8);

---Added a foot switch (see 5.9, 6.9);

---Increase the display (see 5.10, 6.10);

---Added network and software (see 5.12, 6.12);

---Modified the environmental test (see 5.15 and 6.15, 5.12 and 6.12 of the.2009 edition);

---Modified security (see 5.16 and 6.16, 5.13 and 6.13 of the.2009 edition);

---Added the test layout and test phantom (see Appendix A, Appendix B).

1 Scope

This standard specifies the terms and definitions, classification and composition, requirements, and test methods of gastrointestinal X-ray machines (hereinafter referred to as gastrointestinal machines).

This standard applies to the intended use declared by the manufacturer for gastrointestinal X-ray fluoroscopy and photographic examination and to obtain images for clinical diagnosis X-ray machine used.

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 reference documents, the latest version (including all amendments) is applicable 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 standards for radiation protection of diagnostic X-ray equipment common enquiries

GB 9706.14 Medical electrical equipment Part 2: Special requirements for the safety of auxiliary equipment of X-ray equipment

GB/T 10149-1988 Medical X-ray equipment terms and symbols

GB/T 10151-2008 Technical requirements for high-voltage cable plugs and sockets for medical diagnostic X-ray equipment

GB/T 19042.1-2003 Evaluation and routine tests in medical imaging departments Part 3-1.For X-ray photography and fluoroscopy systems X-ray equipment imaging performance acceptance test

YY/T 0291-2016 Environmental requirements and test methods for medical X-ray equipment

YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard

YY/T 0590.3-2011 Characteristics of digital X-ray imaging devices for medical electrical equipment Part 1-3.Quantum detection efficiency Detector for measuring dynamic imaging

YY/T 0608-2013 General technical conditions for medical X-ray image intensifier TV system

YY/T 0910.1 Medical image display system for medical electrical equipment Part 1: Evaluation method

YY 1057-2016 General technical conditions for medical foot switches

IEC 61910-1:2014 Medical electrical equipment radiation dose document Part 1: Photography and fluoroscopy equipment radiation dose structure Report (Medicalelectricalequipment-Radiationdosedocumentation-Part 1: Radiationdosestructured reportsforradiographyandradioscopy)

DICOM3.0 Digital Imaging and Communications in Medicine (Digital Imaging and Communications in Medicine).

3 Terms and definitions

GB 9706.1, GB/T 10149-1988, GB/T 19042.1-2003 and YY/T 0608-2013 and the following terms defined And definitions apply to this document.