IEC TR 61948-1:2001
(Main)Nuclear medicine instrumentation - Routine tests - Part 1: Radiation counting systems
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
- Drafting Committee
- WG 2 - TC 62/SC 62C/WG 2
- Current Stage
- DELPUB - Deleted Publication
- Start Date
- 24-Mar-2016
- Completion Date
- 26-Oct-2025
Relations
- Effective Date
- 05-Sep-2023
Overview
IEC TR 61948-1:2001 provides an essential technical framework for routine testing of radiation counting systems used in nuclear medicine instrumentation. This standard, published by the International Electrotechnical Commission (IEC), focuses specifically on test methods for counting instruments that measure radionuclides both in vivo and in vitro, excluding dose calibrators (activity meters). The document serves as a technical report guiding quality control procedures aimed at ensuring the accuracy, precision, and reliability of nuclear medicine instruments that do not include imaging options.
This standard defines terminology, test methodologies, and practical routines for maintaining equipment performance, making it a valuable reference for manufacturers, clinical engineers, and healthcare professionals responsible for nuclear medicine instrumentation.
Key Topics
1. Scope and Definitions
- Covers radiation counting systems measuring radioactivity in patients or samples without imaging.
- Excludes activity meters (dose calibrators).
- Defines critical terms such as quality control, acceptance testing, routine testing, and specific detector types like well-type detectors, liquid scintillation counters, and Cerenkov counters.
- Distinguishes between in vivo counting systems (e.g., whole-body counters, organ counting systems) and in vitro counting systems (e.g., well-counters with sample changers, multi-detector counters).
2. Test Methods
- Energy Calibration: Establishes the energy scale for the pulse height analyzer using radionuclides with known photon energies, ensuring precise measurement settings.
- Sensitivity Check: Verifies instrument sensitivity with a long-lived radionuclide reference source under fixed geometry and settings.
- Preset Window Setting: Compares preset window counts against manual settings to confirm instrument calibration accuracy.
- Energy Resolution: Measures the ability of detectors to distinguish photon energies, assessed by full width at half maximum (FWHM) of photopeaks.
- Counting Precision: Statistical testing using chi-square to evaluate the consistency and reliability of counting data, with defined acceptance intervals.
- Background Determination: Regular measurement of background radiation levels across energy and window settings to ensure stable operation.
3. Routine Testing Frequency
- Daily tests for background and sensitivity to detect performance changes early.
- Biannual checks for energy calibration, energy resolution, counting precision, and preset window settings to maintain measurement accuracy over time.
Applications
IEC TR 61948-1:2001 is applicable in various nuclear medicine settings where radionuclide quantification without imaging is necessary:
- Clinical laboratories conducting in vitro radionuclide assays for diagnostic or therapeutic monitoring purposes.
- Hospitals employing in vivo counting systems for estimating radioactive substances in the body to support patient care and treatment planning.
- Manufacturers designing and validating radiation counting instruments to meet internationally recognized performance standards.
- Biomedical engineers implementing quality assurance programs to maintain compliance with safety and accuracy requirements in nuclear medicine.
Utilizing this standard facilitates reliable radionuclide measurement, improving diagnostic confidence, patient safety, and operational efficiency in nuclear medicine departments.
Related Standards
IEC TR 61948-1 references and complements other IEC standards critical to nuclear medicine instrumentation and radiological practices:
- IEC 60788: Medical radiology terminology, providing foundational definitions.
- IEC 61145: Calibration and usage guidelines for ionization chamber systems in radionuclide assays.
- IEC 61303: Specific performance measures and testing methods for radionuclide calibrators (dose calibrators).
Together, these standards create a comprehensive suite ensuring standardized procedures for calibration, testing, and quality control of equipment used in nuclear medicine diagnostics and treatment monitoring.
By adhering to IEC TR 61948-1:2001, organizations can implement robust testing protocols for radiation counting systems, ensuring accurate radionuclide measurements critical to effective nuclear medicine applications. Keywords: nuclear medicine instrumentation, radiation counting systems, radionuclide measurement, quality control, energy calibration, counting precision, routine tests, in vivo, in vitro.
Frequently Asked Questions
IEC TR 61948-1:2001 is a technical report published by the International Electrotechnical Commission (IEC). Its full title is "Nuclear medicine instrumentation - Routine tests - Part 1: Radiation counting systems". This standard covers: 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.
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.
IEC TR 61948-1:2001 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC TR 61948-1:2001 has the following relationships with other standards: It is inter standard links to IEC TR 61948-1:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
IEC TR 61948-1:2001 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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.
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Telefax: +41 22 919 0300 e-mail: inmail@iec.ch 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
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