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YY/T 1408-2016Performance characteristics and test methods of imaging system of single photon emission and X-ray computed tomograph (English PDF)

单光子发射及X射线计算机断层成像系统性能和试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 23, 2016

Implementation date

January 1, 2017

Scope

YY/T 1408-2016 is the English-translated version of 单光子发射及X射线计算机断层成像系统性能和试验方法.

YY/T 1408-2016 is the Chinese pharmaceutical industry standard for the combined single photon emission and X-ray computed tomography system (SPECT/CT).

It specifies the performance requirements and the test methods, covering the spatial resolution, sensitivity, uniformity and count rate behaviour of the SPECT part, the image quality and dose of the CT part, the accuracy of the attenuation correction and of the registration between the two data sets, and the safety of the system. Issued on 23 March 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1408-2016

National Standard of the People's Republic of China

ICS
11.040.50
Classification
C 43

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

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 normative reference document
  • 3 Terms and definitions
  • Appendix A (informative) NEMA Standard Publication NU1-2007 "Single Photon Emission Tomography Imaging Performance Test"

Foreword

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

Introduction

Performance and test methods for single photon emission tomography in single photon emission and X-ray computed tomography systems

GB/T 18989-2013, GB/T 18988.2-2013, GB/T 18988.3-2013 related content, X-ray computed tomography Like part of the performance and test methods cited YY/T 0310-2015 related content.

GB/T 18988.2-2013, GB/T 18988.3-2013, GB/T 18989-2013 were modified using IEC 61675-2. 1998, IEC 61675-3.:1998, IEC 60789.:1992.

At present, the production sites of the major manufacturers of radionuclide imaging equipment are located in the United States, its reported parameters, data processing software, Test body are the American Electrical Manufacturers Association (NEMA) as the basis for the design basis, there are manufacturers using IEC standards. For that In the government, enterprises and medical institutions to understand and use these products IEC and NEMA two series of standards, the NEMA standard Publication Contents NU1-2007 "Single Photon Emission Tomography Imaging Performance Test" is included as an informative Appendix A.

As the IEC standard and NEMA standards in the test requirements, test methods, there are some differences, the use of the mold, test conditions, testing Location, calculation methods are different, so the two standard test items can not be compared between each other, it is recommended that the standard user a complete reference to two Any kind of method, not cross the use.

1 Scope

This standard specifies the performance and testing of single photon emission and X-ray computed tomography systems (hereinafter referred to as "SPECT/CT") method.

This standard applies to SPECT/CT, does not apply to independent single photon emission tomography (hereinafter referred to as "SPECT") and independent X-ray computed tomography equipment (hereinafter referred to as "CT").

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 17857-1999 Medical radiology terminology (Radiation therapy, nuclear medicine and radiation dosimetry equipment)

GB/T 18988.2-2013 Radionuclide imaging equipment Performance and test rules - Part 2. Single photon emission computed Layer imaging device

GB/T 18988.3-2013 Radionuclide imaging equipment Performance and test rules - Part 3. Gamma camera body imaging system

GB/T 18989-2013 Radionuclide imaging equipment Performance and test rules Gamma camera General technical requirements for X - ray computed tomography equipment YY/T 0310-2015

3 Terms and definitions

GB/T 17857-1999, GB/T 18988.2-2013, GB/T 18988.3-2013, GB/T 18989-2013, YY/T 0310- 2015 and the following terms and definitions apply to this document.

3.1 Image registration

The process of transforming different image datasets to the same coordinate system. Different image data sets refer to different times and/or different pattern pairs An object is acquired by the acquired data set.

4 Performance and test methods

4.1 SPECT performance and test methods

4.1.1 Overview

If the user is required to refer to the method of Appendix A, it is recommended that the contents of this chapter and Appendix A should not be cross-referenced.

4.1.2 System plane sensitivity

According to GB/T 18989-2013 3.1 in the test method specified.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

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