IEC TR 61948-1:2001

Nuclear medicine instrumentation - Routine tests - Part 1: Radiation counting systems

Describes test methods of counting instruments for measuring radionuclides in vivo and in vitro without the option of imaging. Activity meters (dose calibrators) are excluded.

General Information

• Status: Published
• Publication Date: 12-Feb-2001
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 2 - TC 62/SC 62C/WG 2
• Current Stage: DELPUB - Deleted Publication
• Start Date: 24-Mar-2016
• Completion Date: 14-Feb-2026

Relations

• Revised: IEC TR 61948-1:2016 - Nuclear medicine instrumentation - Routine tests - Part 1: Gamma radiation counting systems
• Effective Date: 05-Sep-2023

Overview

IEC TR 61948-1:2001 - Nuclear medicine instrumentation – Routine tests – Part 1: Radiation counting systems is a technical report published by the International Electrotechnical Commission (IEC). This document provides essential guidance on test methods for radiation counting instruments used to measure radionuclides in both in vivo and in vitro scenarios, specifically excluding imaging devices and activity meters (dose calibrators). It is a valuable resource for clinical, research, and quality assurance professionals aiming for consistent and reliable operation of nuclear medicine counting systems.

Key Topics

• Scope and Definitions

  • Focuses on counting instruments that measure radioactive substances without imaging capability
  • Covers specialized systems such as organ counting systems, wholebody counters, well-type detectors, sample changers, multi-detector counters, liquid scintillation counters, and Cerenkov counters

• Routine Testing Procedures

  • Outlines standardized methods for quality control of instruments, including both acceptance and routine performance tests
  • Defines essential tests for system calibration, resolution, precision, and background measurement

• Terminology and Reference Data

  • Establishes consistent use of key terms such as energy calibration, energy resolution, radionuclide, and activity
  • Emphasizes the importance of collecting reference data during acceptance testing to benchmark subsequent routine tests

• Test Frequency and Quality Assurance

  • Specifies recommended intervals for testing:
    • Background and sensitivity: daily when the instrument is used
    • Energy calibration, energy resolution, counting precision, preset window: twice per year
  • Encourages documentation and detection of performance drift over time

Applications

IEC TR 61948-1:2001 is directly applicable to the following settings and users:

• Clinical Nuclear Medicine Laboratories

  • Ensures radiation counting systems deliver accurate, reproducible results for patient diagnostics and therapeutic monitoring
  • Supports compliance with safety standards and regulatory requirements through systematic testing

• Research Institutions

  • Provides a framework for maintaining instrument performance integrity in experimental setups involving radionuclide quantification

• Medical Physics and Quality Assurance Teams

  • Serves as a reference for establishing quality control programs and training operational staff
  • Aids in managing instrument maintenance scheduling and troubleshooting

• Manufacturers and Service Providers

  • Guides development, validation, and servicing of nuclear medicine counting devices to align with international best practices

Utilization of IEC TR 61948-1 helps mitigate risks of inaccurate measurements, ensures patient and operator safety, and promotes operational efficiency in nuclear medicine facilities.

Related Standards

For comprehensive implementation, the following related IEC standards are recommended alongside IEC TR 61948-1:

• IEC 60788: Medical radiology – Terminology

  • Provides definitions and terminology for consistency across documents.

• IEC 61303: Medical electrical equipment – Radionuclide calibrators – Particular methods for describing performance

  • Specifies performance description methods for calibrators not covered in this report.

• IEC 61145: Calibration and usage of ionization chamber systems for assay of radionuclides

  • Details calibration and usage procedures for ionization chamber-based assays.

These documents collectively ensure thorough understanding, reliable operation, and consistent testing of nuclear medicine instrumentation.

Practical Value

Implementing IEC TR 61948-1 enhances the reliability, traceability, and safety of quantitative measurements in nuclear medicine. By adhering to its standardized test methods and routines, practitioners support both clinical accuracy and regulatory compliance, benefiting patient outcomes and operational robustness in healthcare and research environments.

Standards Content (Sample)

TECHNICAL IEC
REPORT
TR 61948-1
First edition
2001-02
Nuclear medicine instrumentation –
Routine tests –
Part 1:
Radiation counting systems
Instrumentation en médecine nucléaire –
Essais de routine –
Partie 1:
Systèmes compteurs de rayonnement
Reference number
IEC/TR 61948-1:2001(E)
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
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thus ensuring that the content reflects current technology. Information relating to
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TECHNICAL IEC
REPORT
TR 61948-1
First edition
2001-02
Nuclear medicine instrumentation –
Routine tests –
Part 1:
Radiation counting systems
Instrumentation en médecine nucléaire –
Essais de routine –
Partie 1:
Systèmes compteurs de rayonnement
 IEC 2001  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
K
International Electrotechnical Commission
For price, see current catalogue

– 2 – TR 61948-1  IEC:2001(E)
CONTENTS
Page
FOREWORD . 3
Clause
1 Scope and object . 5
2 Reference documents . 5
3 Terminology and definitions . 5
4 Test methods .7
NERGY CALIBRATION
4.1 E . 7
4.2 Sensitivity check . 8
4.3 Preset window setting . 8
4.4 ENERGY RESOLUTION . 8
4.5 COUNTING PRECISION. 8
4.6 Background . 8
ROUTINE TESTS
4.7 Frequency of . 8
Annex A Index of defined terms . 10

TR 61948-1  IEC:2001(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
NUCLEAR MEDICINE INSTRUMENTATION –
ROUTINE TESTS –
Part 1: Radiation counting systems
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International
Organization for Standardization (ISO) in accordance with conditions determined by agreement between the
two organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this technical report may be the subject of
patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 61948-1, which is a technical report, has been prepared by subcommittee 62C:
Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical
committee 62: Electrical equipment in medical practice.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62C/255/CDV 62C/265A/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.

– 4 – TR 61948-1  IEC:2001(E)
In this technical report the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller roman
type;
– test specifications: in italic type;
– TERMS DEFINED IN CLAUSE 3 OF THIS TECHNICAL REPORT OR LISTED IN ANNEX A: SMALL CAPITALS.
The requirements are followed by specifications for the relevant tests.
The committee has decided that the contents of this publication will remain unchanged until
2005. At this date, the publication will be
reconfirmed;
withdrawn;
replaced by a revised edition, or
amended.
This document, which is purely informative, is not to be regarded as an International
Standard.
TR 61948-1  IEC:2001(E) – 5 –
NUCLEAR MEDICINE INSTRUMENTATION –
ROUTINE TESTS –
Part 1: Radiation counting systems
1 Scope and object
This technical report describes test methods of counting instruments for measuring
RADIONUCLIDES in vivo and in vitro without the option of imaging. ACTIVITY meters (dose
calibrators) are excluded.
2 Reference documents
IEC 60788:1984, Medical radiology – Terminology
IEC 61145:1992, Calibration and usage of ionization chamber systems for assay of
radionuclides
IEC 61303:1994, Medical electrical equipment – Radionuclide calibrators – Particular methods
for describing performance
3 Terminology and definitions
For the purposes of this part of IEC 61948, the definitions given in IEC 60788, IEC 61303 and
IEC 61145 and the following definitions apply (see annex A). Defined terms are printed in
small capital letters.
3.1
QUALITY CONTROL
part of the quality assurance in nuclear medicine including tests of instruments with
appropriate test methods
NOTE Includes both ACCEPTANCE TESTING and ROUTINE TESTING.
3.2 Methodology
3.2.1
ACCEPTANCE TEST
test carried out at the request and with the participation of the user or his representative to
ascertain by determination of proper performance parameters that the instrument meets the
specifications claimed by the vendor
NOTE AN ACCEPTANCE TEST should be carried out at the time of installation and when appropriate after major
service. During or immediately after ACCEPTANCE TESTING, REFERENCE DATA are collected to be used
...