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YY/T 0063-2024Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (English PDF)

医用电气设备 医用诊断X射线管组件 焦点尺寸及相关特性

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 8, 2024

Implementation date

July 20, 2025

Scope

YY/T 0063-2024 is the English-translated version of 医用电气设备 医用诊断X射线管组件 焦点尺寸及相关特性.

YY/T 0063 governs how the focal spot of a diagnostic X-ray tube is defined and measured. The focal spot is the area on the anode where the electron beam lands, and its size sets the geometric sharpness of every image the tube produces: a nominally small focal spot that is actually larger blurs fine detail in a way no reconstruction recovers. The standard fixes the dimensions and related characteristics and the methods for determining them, which is what makes a manufacturer's declared focal spot value comparable between tubes and verifiable by a purchaser. It is the Chinese adoption of the international method used across the industry. For a manufacturer of X-ray tube assemblies, a system integrator specifying them, or a test laboratory serving either, this is the reference behind the focal spot declaration.

Document preview — YY/T 0063-2024

National Standard of the People's Republic of China

ICS
11.040.50
Classification
C43
Replacing
YY/T 0063-2007

Issued by: National Medical Products Administration

Contents

  • 1 Scope1
  • 2 Normative references1
  • 3 Terms and Definitions1
  • 4 Determination of focal characteristics evaluation3
  • 4.1 Key Features Statement3
  • 4.2 X-ray tube assembly longitudinal axis3
  • 4.3 X-ray tube assembly reference axis3
  • 4.4 Evaluation direction of focal length3
  • 4.5 Evaluation direction of focal width3
  • 4.6 Evaluation direction of deformation focus3
  • 5 Focus Camera Settings4
  • 5.1 Overview4
  • 5.2 Slit Camera Aperture4
  • 5.3 Pinhole Camera Aperture5
  • 5.4 Receiver5
  • 5.5 Test layout5
  • 5.6 Total uncertainty of the camera setup 8 6 X-ray photography9
  • 6.1 General9
  • 6.2 Operating conditions9
  • 6.3 Determination of focal slit radiographs, focal pinhole radiographs and focal line spread function10
  • 6.4 Conformity statement for focal pinhole radiographs10
  • 6.5 Line spread function conformity statement11
  • 7 Determination of focal spot size and focal spot nominal value11
  • 7.1 Overview11
  • 7.2 Determination of focal spot size11
  • 7.3 Specifying the nominal value of focal point12
  • 7.4 Statement of Conformity13
  • 7.5 Conformity marking13
  • 8 Determination of Modulation Transfer Function14
  • 8.1 Overview14
  • 8.2 Calculation and Representation of Modulation Transfer Function14
  • 30 Index31

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 for standardization documents" Drafting. This document replaces YY/T 0063-2007 "Focal Characteristics of Medical Electrical Equipment Medical Diagnostic X-ray Tube Assemblies" and is consistent with Compared with YY/T 0063-2007, in addition to structural adjustments and editorial changes, the main technical changes are as follows:

a) The scope has been changed (see Chapter 1, Chapter 1 of the.2007 edition);

b) The terms and definitions have been changed (see Chapter 3, Chapter 3 of the.2007 edition);

c) Added the evaluation direction of deformation focus (see 4.6);

1 Scope

YY/T 0063 governs how the focal spot of a diagnostic X-ray tube is defined and measured. The focal spot is the area on the anode where the electron beam lands, and its size sets the geometric sharpness of every image the tube produces: a nominally small focal spot that is actually larger blurs fine detail in a way no reconstruction recovers. The standard fixes the dimensions and related characteristics and the methods for determining them, which is what makes a manufacturer's declared focal spot value comparable between tubes and verifiable by a purchaser. It is the Chinese adoption of the international method used across the industry. For a manufacturer of X-ray tube assemblies, a system integrator specifying them, or a test laboratory serving either, this is the reference behind the focal spot declaration.

This document applies to the focal point of medical diagnostic X-ray tube assemblies operating at X-ray tube voltages of 150 kV and below. This document describes a test method for the determination of the following using a digital detector.

a) The focal point size expressed as the focal point nominal value, ranging from

0.1 to 3.0;

b) Line spread function;

c) one-dimensional modulation transfer function;

d) Focal pinhole radiograph. This document also describes the means of demonstrating compliance. In the informative appendices, star card imaging (see Appendix A) and defocus values (see Appendix B) are described.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this text. The version corresponding to that date applies to this document; for undated referenced documents, their latest versions (including all amendments) apply to this document.

GB 9706.1-2020 Medical electrical equipment Part

1.General requirements for basic safety and essential performance ( IEC 60601-1. 2012,MOD)

GB 9706.103-2020 Medical electrical equipment Part 1-

3.General requirements for basic safety and essential performance Collateral standard. Diagnostic Radiation protection for X-ray equipment ( IEC 60601-1-3.2013, MOD)

YY/T 0064-2016 Electrical and load characteristics of medical diagnostic X-ray tube assemblies ( IEC 60613.2010, IDT)

GB/T 5465.2-2008 Graphical symbols for electrical equipment Part

3 Terms and definitions

IEC TR60788.2004, YY/T 0064-2016, GB 9706.1-2020 and GB 9706.103-2020 and the following The following terms and definitions apply to this document.

3.1 actual focal spot The area on the target surface that stops the accelerated particle beam. NOTE. Regarding the accelerated particles, only the expected primary beam is included.

3.2 Defocus value blooming value The ratio of two limiting resolutions obtained under specific loading conditions. NOTE. The defocus value is a characteristic of the effective focal spot of the X-ray tube.

5 Focus Camera Settings

5.2 Test equipment" (see

5.2 of the.2007 edition);

e) Added "Slit camera aperture" (see 5.2);

f) Added "pinhole camera aperture" (see 5.3);

g) Added "receiver" (see 5.4);

h) The "Test Layout" has been changed (see 5.5,

5.3 of the.2007 edition);

i) Changed "Total uncertainty of camera settings" (see 5.6,

5.4 of the.2007 edition);

j) Changed "Overview" (see 6.1,

6.1 of the.2007 edition);

k) Changed "Operating conditions" (see 6.2,

6.2 of the.2007 edition);

l) Changed "Determination of focal slit radiographs, focal pinhole radiographs and focal line spread function" (see 6.3,.2007 edition) 6.3);

m) Added "Line spread function conformity statement" (see 6.5);

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 35 pages — is available in the English PDF.

Referenced standards

Similar standards

YY/T 0128|YY/T 0106|YY/T 0292.1|YY/T 0062.1|YY/T 0064

Editions of YY/T 0063

EditionTitleRevisionStatus
YY/T 0063-2024Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristicscurrent editionCurrent
YY/T 0063-2007Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristicsprevious editionIn force until 2025-07-20

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