IEC TR 61948-4:2019

Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators

IEC TR 61948-4:2019 covers the routine testing of radionuclide calibrators used in nuclear medicine. Such devices utilise ionisation chambers of the well type and a direct readout in units of activity. Requirements and specific methods to determine performance parameters are described in IEC 61303. These methods are primarily designed for acceptance testing. IEC TR 61948-4:2019 cancels and replaces the first edition published in 2006. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: the test method to determine system linearity has been updated to reflect the technical developments of radionuclide calibrators.

General Information

• Status: Published
• Publication Date: 21-Mar-2019
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• 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: PPUB - Publication issued
• Start Date: 22-Mar-2019
• Completion Date: 22-Mar-2019

Relations

• Revises: IEC TR 61948-4:2006 - Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC TR 61948-4 ®
Edition 2.0 2019-03
TECHNICAL
REPORT
Nuclear medicine instrumentation – Routine tests –
Part 4: Radionuclide calibrators

All rights reserved. Unless otherwise specified, 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
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and Definitions clause of
IEC publications issued since 2002. Some entries have been
IEC Customer Service Centre - webstore.iec.ch/csc collected from earlier publications of IEC TC 37, 77, 86 and
If you wish to give us your feedback on this publication or CISPR.

need further assistance, please contact the Customer Service

Centre: [e-mail].
IEC TR 61948-4 ®
Edition 2.0 2019-03
TECHNICAL
REPORT
Nuclear medicine instrumentation – Routine tests –

Part 4: Radionuclide calibrators

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-6602-1

– 2 – IEC TR 61948-4:2019 © IEC 2019
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Test methods . 7
4.1 BACKGROUND RESPONSE . 7
4.2 Constancy of instrument response . 7
4.3 SYSTEM LINEARITY . 7
4.3.1 General . 7
4.3.2 Decaying source method . 7
4.3.3 Data analysis . 7
4.4 Additional checks . 7
4.5 Frequency of ROUTINE TESTS . 7
Bibliography . 9
Index of defined terms . 10

Table 1 – Frequency of ROUTINE TESTS . 8

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
NUCLEAR MEDICINE INSTRUMENTATION – ROUTINE TESTS –

Part 4: Radionuclide calibrators

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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. 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 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 IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. 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 TR 61948-4, 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.
This second edition cancels and replaces the first edition published in 2006. This edition
constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: the test method to determine SYSTEM LINEARITY has been updated to reflect the
technical developments of RADIONUCLIDE CALIBRATORS.

– 4 – IEC TR 61948-4:2019 © IEC 2019
The text of this Technical Report is based on the following documents:
Draft TR Report on voting
62C/715/DTR 62C/727/RVDTR
Full information on the voting for the approval of this Technical Report can be
...

IEC TR 61948-4 ®
Edition 2.0 2019-03
REDLINE VERSION
TECHNICAL
REPORT
colour
inside
Nuclear medicine instrumentation – Routine tests –
Part 4: Radionuclide calibrators

All rights reserved. Unless otherwise specified, 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
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and Definitions clause of
IEC publications issued since 2002. Some entries have been
IEC Customer Service Centre - webstore.iec.ch/csc collected from earlier publications of IEC TC 37, 77, 86 and
If you wish to give us your feedback on this publication or CISPR.

need further assistance, please contact the Customer Service

Centre: [e-mail].
IEC TR 61948-4 ®
Edition 2.0 2019-03
REDLINE VERSION
TECHNICAL
REPORT
colour
inside
Nuclear medicine instrumentation – Routine tests –

Part 4: Radionuclide calibrators

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-6727-1

– 2 – IEC TR 61948-4:2019 RLV © IEC 2019
CONTENTS
FOREWORD . 3
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Test methods . 8
4.1 BACKGROUND RESPONSE . 8
4.2 Constancy of instrument response . 8
4.3 SYSTEM LINEARITY . 8
4.3.1 General . 8
4.3.2 Decaying source method . 9
4.3.3 Data analysis . 9
4.4 Additional checks . 9
4.5 Frequency of ROUTINE TESTS . 9
Bibliography . 10
Index of defined terms . 11

Table 1 – Frequency of ROUTINE TESTS . 9

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
NUCLEAR MEDICINE INSTRUMENTATION – ROUTINE TESTS –

Part 4: Radionuclide calibrators

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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. 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 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 IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.

– 4 – IEC TR 61948-4:2019 RLV © IEC 2019
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 TR 61948-4, 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.
This second edition cancels and replaces the first edition published in 2006. This edition
constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: the test method to determine SYSTEM LINEARITY has been updated to reflect the
technical developments of RADIONUCLIDE CALIBRATORS.
The text of this Technical Report is based on the following documents:
Draft TR Report on voting
62C/715/DTR 62C/727/RVDTR
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 document has been drafted in accordance with the ISO/IEC Directives, Part 2.
Terms used throughout this document that have been defined in Clause 3 appear in SMALL
CAPITALS.
A list of all parts in the IEC 61948 series, published under the general title Nuclear medicine
Instrumentation – Routine tests, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

INTRODUCTION
This technical report is based on the German Standard DIN 6855-11, Qualitätsprüfung
nuklearmedizinischer Messsysteme – Teil 11: Konstanzprüfung von Aktivimetern, the English
document Protocol for Establishing and Maintaining the Calibration of Medical Radionuclide
Calibrators and their Quality Control, the Austrian document ÖNORM S 5270, Aktivimeter –
Richtlinien für die Konstanzprüfung am Verwendungsort / Radionuclide calibrators –
Guidelines for the constancy testing in the field / Calibrateurs de radionucléides – Directives
pour l'essai de constance à l'endroit d'utilisation, of 1 April 1998, and the Spanish document
Protocolo Nacional del Control de Calidad en la Instrumentación en Medicina Nuclear.

– 6 – IEC TR 61948-4:2019 RLV © IEC 2019
NUCLEAR MEDICINE INSTRUMENTATION – ROUTINE TESTS –

Part 4: Radionuclide calibrators

1 Scope and object
This part of IEC 61948 covers the ROUTINE TESTING of RADIONUCLIDE CALIBRATORS used in
nuclear medicine. Such devices utilise ionisation chambers of the well type (directly coupled
to an appropriate electronic circuitry (IEC 61145)) and a direct readout in units of ACTIVITY.
Requirements and specific methods to determine performance parameters are described in
IEC 61303 and IEC 61145. These methods are primarily designed for ACCEPTANCE TESTING.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their
content constitutes requirements of this document. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document (including
any amendments) applies.
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
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
IEC 61948-1:2001, Nuclear medicine instrumentation – Routine tests – Part 1: Radiation
counting systems
3 Terms and definitions
For the purpose of this document, the terms and definitions given in IEC TR 60788:2004,
IEC 61303:1994 and IEC 61145:1992, some of which are repeated here for convenience, and
the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE Defined terms are printed in small capital letters.
3.1
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 as a standard for
comparison with future ROUTINE TESTS.
[IEC 61948-1:2001, definition 3.2.1]

test carried out after new equipment has been installed, or major modifications have been
made to existing equipment, in order to verify compliance w
...