YY/T 0934-2022Dynamic digital medical X-ray image detectors (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document replaces YY/T 0934-2014 "Medical Dynamic Digital X-ray Image Detector", this document and YY/T 0934- Compared with.2014, the main technical changes are as follows.

a) Changed the version of some referenced documents in "Normative Reference Documents" to refer to the latest version (see Chapter 2,.2014 edition of chapter 2);

b) Deleted the term and definition of "dose linear range" (see 3.1 of the.2014 edition);

c) Changed the definitions of "linear dynamic range" and "frame rate" (see 3.7, 3.8, 3.3, 3.4 of the.2014 edition);

d) Added "calibration", "bright field image", "dark field image", "mode", "noise equivalent dose", "additional hysteresis effect" and "proliferative hysteresis effect" and "Inter-frame grayscale stability" with a total of 8 terms and definitions (see 3.2, 3.3, 3.4, 3.5, 3.6, 3.9, 3.10 and 3.11);

e) Changed the description of "composition" and added embedded software (see Chapter 4, Chapter 4 of the.2014 edition);

f) Deleted "Dose Linear Range" (see 5.4 of the.2014 edition);

g) Added the "image quality" requirement, and included the separate requirements related to image quality under this clause (see 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 and 5.4.10,.2014 editions 5.5, 5.6, 5.7, 5.8, 5.9, 5.10 and 5.11);

h) The test methods of "Noise Equivalent Dose" (see 5.4.1) and "Noise Equivalent Dose" (see 6.4.1) were added;

i) Changed the "Linear dynamic range" (see 5.4.2, 5.5 of the.2014 edition) and the "Linear dynamic range" test method (see 6.4.2,.2014 6.4 and 6.5 of the year edition);

j) Changed the expression requirements of "frame rate" (see 5.4.3, 5.6 of the.2014 edition);

k) Changed "Line pair resolution" to "Spatial resolution" (see 5.4.4, 5.7 of the.2014 edition), changed the "Spatial resolution" test methods (see 6.4.4, 6.7 of the.2014 edition);

l) Changed the expression of "modulation transfer function" spatial frequency (see 5.4.5, 5.8 of the.2014 edition);

m) Changed the expression of "quantum detection efficiency" spatial frequency (see 5.4.6, 5.9 of the.2014 edition), changed the "quantum detection efficiency" rate" recording method (see 6.4.6, 6.9 of the.2014 edition);

n) Deleted "afterimage" (see 5.10 of the.2014 edition);

o) Added "Additional Hysteresis Effect" (see 5.4.7) and "Additional Hysteresis Effect" test methods (see 6.4.7);

p) Added the test methods for "proliferation lag effect" (see 5.4.8) and "proliferation lag effect" (see 6.4.8);

q) The test methods of "gray stability between frames" (see 5.4.9) and "gray stability between frames" (see 6.4.9) were added;

r) Changed the serial number of "artifacts" (see 5.4.10, 5.11 of the.2014 edition) and the test method of "artifacts" (see 6.4.10, of the.2014 edition 6.11);

s) Added the verification methods of "communication" (see 5.5) and "communication" (see 6.5);

t) Changed the serial number of "test environment", changed the version of referenced documents and the serial number of intermediate inspection items (see 5.7 and 6.7,.2014 version 5.13 and 6.13);

u) Deleted "Security" (see 5.14 and 6.14 of the.2014 edition);

v) Deleted "Inspection Rules", "Identification, Labeling, Instructions for Use", "Packaging, Transportation and Storage" (see Chapter 7, Section.2014 of the.2014 edition) Chapters 8 and 9);

w) Added the test layout of Appendix A (see Appendix A).

1 Scope

This document specifies the terms and definitions, composition, requirements and experiment method. This document applies to medical dynamic digital X-ray image detectors. This document does not apply to.

--- detectors for dental photography;

--- Image intensifier imaging system.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 10149 Terms and Symbols of Medical X-ray Equipment

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

YY/T 0481-2016 Radiation conditions for the determination of characteristics of medical diagnostic X-ray equipment

YY/T 0590.3 Characteristics of Digital X-ray Imaging Devices for Medical Electrical Equipment Part 1-3.Determination of Quantum Detection Efficiency Detector for state imaging

3 Terms and Definitions

The terms and definitions defined in GB/T 10149, YY/T 0481-2016 and YY/T 0590.3 and the following terms and definitions apply to this document.