GB/T 20013.1-2025Nuclear medicine instrumentation - Routine tests - Part 1: Gamma radiation counting systems (English PDF)

Foreword

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

Drafting.

This document is Part 1 of GB/T 20013 "Routine Testing of Nuclear Medicine Instruments". GB/T 20013 has already published the following parts.

---Part 1: Gamma Radiation Counting System;

---Part 2: Scintillation Cameras and Single-Photon Emission Computed Tomography Apparatus;

---Part 3: Positron Emission Tomography Apparatus;

---Part 4: Radionuclide Calibrator this document supersedes GB/T 20013.1-2005 "Routine testing of nuclear medicine instruments - Part 1: Radiation counting systems" and is consistent with...

Compared with GB/T 20013.1-2005, apart from structural adjustments and editorial changes, the main technical changes are as follows.

---The scope has been changed to explicitly exclude the Geiger-Miller counter (see Chapter 1, Chapter 1 of the 2005 edition);

--- The energy calibration has been changed, now divided into energy calibration and energy calibration linearity (see 4.3 and 4.4, 4.1 in the 2005 edition);

---The preset window settings have been removed (see version 4.3 in 2005).

This document is equivalent to IEC TR61948-1:2016 "Routine testing of nuclear medicine instruments - Part 1: Gamma radiation counting systems".

The component type has been changed from the IEC technical report to my country's national standard.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Electrical Appliances (SAT/TC10).

Introduction

GB/T 20013 "Routine Tests for Nuclear Medicine Instruments" aims to describe the procedures that users of nuclear medicine instruments must perform to maintain appropriate operating conditions.

The routine test is planned to consist of four parts.

---Part 1: Gamma Radiation Counting System. The purpose is to describe routine tests of a gamma radiation counting system.

---Part 2: Scintillation Cameras and Single-Photon Emission Computed Tomography Apparatus. The purpose is to describe scintillation cameras and single-photon emission computed tomography apparatuses.

Routine testing of the sub-emission computed tomography imaging device.

---Part 3: Positron Emission Tomography Apparatus. The purpose is to describe routine testing of a positron emission tomography apparatus.

---Part 4: Radionuclide Calibrator. The purpose is to describe routine tests of a radionuclide calibrator.

Routine testing of nuclear medicine instruments Part 1: Gamma Radiation Counting System

1 Scope

This document describes experimental methods for non-imaging methods of counting systems for in vivo and in vitro radionuclides.

This document applies to gamma radiation counting systems, such as well counters and organprobes.

This document does not apply to Geiger-Mueler counters and activity meters (dose calibrators).

As part of quality control, this document describes examples that users of gamma radiation counting systems must perform to maintain proper operating conditions.

Routine tests will be conducted. The results of routine tests will be compared with reference data determined during or after acceptance testing.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

Note. GB/T 17857-1999 Medical Radiology Terminology (Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment) (eqvIEC 60788.1984)

3 Terms and Definitions

The terms and definitions defined in IEC TR60788 and the following terms and definitions apply to this document.

Acceptance test

Tests conducted after the installation of new equipment or after significant modifications to existing equipment are used to verify that the equipment meets the requirements of the contract.

Note. Reference data should be collected during or immediately after the acceptance test as a standard for comparison with future routine tests.

[Source. IEC TR60788:2004, rm-70-01, modified] 3.2 activity A quantitative expression of the radioactivity of a certain amount of a radionuclide at a specific energy level at a given moment. It is calculated by dividing dN by dt.

The quotient is determined, see formula (1).

A=dN/dt (1)

In the formula.

dN --- the expected number of atomic nuclei decaying at a given energy level within a time interval dt;

dt --- time interval.

Note. The unit of activity is negative first-order second (s-1). The proper name for the unit of activity is becquerel (Bq), 1 Bq = 1 s-1. An earlier unit of activity was the cubic unit.

里(Ci),1Ci=3.7×1010Bq.

[Source. IEC TR60788:2004, rm-13-18]