IEC 61676:2002

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

Specifies the performance requirements of instruments as used in the non-invasive measurement of X-ray tube voltage up to 150 kV and the relevant compliance tests. Describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. This standard is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1.

General Information

• Status: Published
• Publication Date: 25-Jan-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 3 - TC 62/SC 62C/WG 3
• Current Stage: DELPUB - Deleted Publication
• Start Date: 06-Nov-2020
• Completion Date: 21-Mar-2023

Relations

• Amended By: IEC 61676:2002/AMD1:2008 - Amendment 1 - Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
• Effective Date: 05-Sep-2023
• Revised: IEC 61676:2023 - Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
First edition
2002-09
Medical electrical equipment –
Dosimetric instruments used for
non-invasive measurement of X-ray
tube voltage in diagnostic radiology
Appareils électromédicaux –
Instruments de dosimétrie pour la mesure
non invasive de la tension du tube radiogène
dans la radiologie de diagnostic
Reference number
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.
Further information on IEC publications
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology. Information relating to
this publication, including its validity, is available in the IEC Catalogue of
publications (see below) in addition to new editions, amendments and corrigenda.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is also available from the following:
• IEC Web Site (www.iec.ch)
• Catalogue of IEC publications
The on-line catalogue on the IEC web site (http://www.iec.ch/searchpub/cur_fut.htm)
enables you to search by a variety of criteria including text searches, technical
committees and date of publication. On-line information is also available on
recently issued publications, withdrawn and replaced publications, as well as
corrigenda.
• IEC Just Published
This summary of recently issued publications (http://www.iec.ch/online_news/
justpub/jp_entry.htm) is also available by email. Please contact the Customer
Service Centre (see below) for further information.
• Customer Service Centre
If you have any questions regarding this publication or need further assistance,
please contact the Customer Service Centre:
Email: [e-mail]
Tel: [phone]
Fax: [phone]
INTERNATIONAL IEC
STANDARD
First edition
2002-09
Medical electrical equipment –
Dosimetric instruments used for
non-invasive measurement of X-ray
tube voltage in diagnostic radiology
Appareils électromédicaux –
Instruments de dosimétrie pour la mesure
non invasive de la tension du tube radiogène
dans la radiologie de diagnostic
 IEC 2002  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, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail]  Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
V
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

– 2 – 61676  IEC:2002(E)
CONTENTS
FOREWORD . 3
INTRODUCTION .5
1 Scope and object . 6
2 Normative references. 6
3 Terminology and definitions . 7
4 General performance requirements for measurement of PRACTICAL PEAK VOLTAGE
measurements .10
4.1 Quantity to be measured.10
4.2 Limits of PERFORMANCE CHARACTERISTICs .10
4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES .13
4.4 Performance test procedures.15
5 Special instrumental requirements and marking .21
5.1 Requirements for the complete instruments .21
5.2 General .21
5.3 Display .22
5.4 Range of measurement.22
5.5 Connectors and cables .22
6ACCOMPANYING DOCUMENTS .22
6.1 General .22
6.2 Information provided.22
6.3 Instrument description .22
6.4 Detector.22
6.5 Delay time .22
6.6 Measurement window .22
6.7 Data outlet.23
6.8 Transport and storage .23
Annex A (informative) Recommended performance criteria for the invasive divider .24
Annex B (informative) Additional information on PRACTICAL PEAK VOLTAGE .25
Annex C (informative) Glossary of defined terms.32

61676  IEC:2002(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION

MEDICAL ELECTRICAL EQUIPMENT –
Dosimetric instruments used for non-invasive measurement
of X-ray tube voltage in diagnostic radiology
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 International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61676 has been prepared by subcommittee SC 62C: Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC Technical Committee 62:
Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/340/FDIS 62C/344/RVD
Full information on the voting for the approval of this standard 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.
Annexes A, B and C are for information only.
In this standard the following print types are used:
− requirements, compliance with which can be tested, and definitions: in roman type;
− notes, explanations, advice, general statements and exceptions: in small roman type;
− test specifications: in italic type;
− TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN IEC
60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS.

– 4 – 61676  IEC:2002(E)
The committee has decided that the contents of this publication will remain unchanged until
2004. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.
NOTE The committee is aware of the fact that this standard does not address all problems associated with non-
invasive high voltage measurements. In particular one influence quantity concerning the target condition is not
dealt with at all. Before this can be done, a substantial amount of measurements is still necessary to improve the
physical understanding of this influence quantity. On the other hand, for the reasons described in the introduction
there is an urgent need to publish this standard in order to assure that non-invasive measurements are comparable
to each other within tolerable uncertainties, regardless of differences in X-RAY GENERATOR, waveform or other
influence quantities (except target condition), which is not the case for the time being. The committee has decided
to revise this standard as soon as sufficient knowledge on the outstanding items is available.

61676  IEC:2002(E) – 5 –
INTRODUCTION
The result of a measurement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasive
instruments is normally expressed in the form of one single number for the value of the tube
voltage, irrespective of whether the tube voltage is constant potential or shows a time
dependent waveform. Non-invasive instruments for the measurement of the X-RAY TUBE
VOLTAGE on the market usually indicate the ‘mean peak voltage’. But the quantity ‘mean peak
voltage’ is not unambiguously defined and may be any mean of all voltage peaks. It is
impossible to establish test procedures for the performance requirements of non-invasive
instruments for the measurement of the X-RAY TUBE VOLTAGE without the definition of the
quantity under consideration. Therefore, this Standard is based on a quantity recently
proposed in the literature to be called "PRACTICAL PEAK VOLTAGE". The PRACTICAL PEAK
VOLTAGE is unambiguously defined and applicable to any waveform. This quantity is related to
the spectral distribution of the emitted X-RADIATION and the image properties. X-RAY
GENERATORS operating at the same value of the PRACTICAL PEAK VOLTAGE will produce the
same low level contrast in the RADIOGRAMS, even when the waveforms of the tube voltages
are different. Detailed information on this concept is provided in Annex B. An example for the
calculation of the PRACTICAL PEAK VOLTAGE in the case of a “falling load” waveform is also
given in Annex B.
As a result of introducing a new quantity, the problem arises that this standard has been
written for instruments which were not explicitly designed for the measurement of the
PRACTICAL PEAK VOLTAGE. However, from preliminary results of a trial type test of a non-
invasive instrument currently on the market, it can be expected that future instruments and
most instruments on the market will be able to fulfil the requirements stated in this standard
without insurmountable difficulties. For the most critical requirements on voltage waveform
and frequency dependence of the RESPONSE, it turned out from these investigations that it is
even easier to comply with the standard by using the PRACTICAL PEAK VOLTAGE as the
measurement quantity.
The calibration and adjustment of the X-RAY TUBE VOLTAGE of an X-RAY GENERATOR is generally
performed by the MANUFACTURER using a direct INVASIVE MEASUREMENT. Instruments utilising
NON-INVASIVE MEASUREMENTS can also be used to check the calibration or to adjust THE X-RAY
TUBE VOLTAGE. These instruments are required to have uncertainties of the voltage
measurement comparable with the INVASIVE MEASUREMENT. One of the most important
parameters of diagnostic X-RAY EQUIPMENT is the voltage applied to the X-RAY TUBE, because
both the image quality in diagnostic radiology and the DOSE received by the PATIENT
undergoing radiological examinations are dependent on the X-RAY TUBE VOLTAGE. An overall
uncertainty below ±5 % is required, and this value serves as a guide for the LIMITS OF
VARIATION for the effects of INFLUENCE QUANTITIES.
———————
See annex B.
– 6 – 61676  IEC:2002(E)
MEDICAL ELECTRICAL EQUIPMENT –
Dosimetric instruments used for non-invasive measurement
of X-ray tube voltage in diagnostic radiology
1 Scope and object
This International Standard specifies the performance requirements of instruments as used in
the NO
...

IEC 61676 ®
Edition 1.1 2009-01
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
Medical electrical equipment – Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology

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 Fax: [phone]

CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.

Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.

IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: [e-mail].

IEC 61676 ®
Edition 1.1 2009-01
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
Medical electrical equipment – Dosimetric instruments used for non-invasive

measurement of X-ray tube voltage in diagnostic radiology

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50; 11.040.55 ISBN 978-2-8891-0552-6

– 2 – 61676 © IEC:2002+A1:2008(E)

CONTENTS
FOREWORD.3

INTRODUCTION.5

1 Scope and object.6

2 Normative references.6

3 Terminology and definitions.7

4 General performance requirements for measurement of PRACTICAL PEAK VOLTAGE

measurements.10
4.1 Quantity to be measured .10
4.2 Limits of PERFORMANCE CHARACTERISTICs .10
4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES.13
4.4 Performance test procedures.15
5 Special instrumental requirements and marking.22
5.1 Requirements for the complete instruments.22
5.2 General.22
5.3 Display.22
5.4 Range of measurement .22
5.5 Connectors and cables.22
6 ACCOMPANYING DOCUMENTS.23
6.1 General.23
6.2 Information provided.23
6.3 Instrument description.23
6.4 Detector.23
6.5 Delay time.23
6.6 Measurement window.23
6.7 Data outlet.23
6.8 Transport and storage.23

Annex A (informative) Recommended performance criteria for the invasive divider .24
Annex B (informative) Additional information on PRACTICAL PEAK VOLTAGE .25
Annex C (informative) Glossary of defined terms .32

61676 © IEC:2002+A1:2008 (E) – 3 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION

⎯⎯⎯⎯⎯
MEDICAL ELECTRICAL EQUIPMENT –

Dosimetric instruments used for non-invasive measurement

of X-ray tube voltage in diagnostic radiology

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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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 consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 61676 edition 1.1 contains the first edition (2002) [documents 62C/340/FDIS and
62C/344/RVD] and its amendment 1 (2008) [documents 62C/445/CDV and 62C/452/RVC].
A vertical line in the margin shows where the base publication has been modified by
amendment 1.
International Standard IEC 61676 has been prepared by subcommittee SC 62C: Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC Technical Committee 62:
Electrical equipment in medical practice.
NOTE In the amendment, a new influence quantity “Additional tungsten filtration (tube aging)” has been
introduced.
– 4 – 61676 © IEC:2002+A1:2008(E)

Annexes A, B and C are for information only.

In this standard the following print types are used:

− requirements, compliance with which can be tested, and definitions: in roman type;

− notes, explanations, advice, general statements and exceptions: in small roman type;

− test specifications: in italic type;

− TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN IEC

60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS.

The committee has decided that the contents of the base publication and its amendments will
remain unchanged until the maintenance result date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date,
the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

NOTE The committee is aware of the fact that this standard does not address all problems associated with non-
invasive high voltage measurements. In particular one influence quantity concerning the target condition is not
dealt with at all. Before this can be done, a substantial amount of measurements is still necessary to improve the
physical understanding of this influence quantity. On the other hand, for the reasons described in the introduction
there is an urgent need to publish this standard in order to assure that non-invasive measurements are comparable
to each other within tolerable uncertainties, regardless of differences in X-RAY GENERATOR, waveform or other
influence quantities (except target condition), which is not the case for the time being. The committee has decided
to revise this standard as soon as sufficient knowledge on the outstanding items is available.

61676 © IEC:2002+A1:2008 (E) – 5 –

INTRODUCTION
The result of a measurement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasive

instruments is normally expressed in the form of one single number for the value of the tube

voltage, irrespective of whether the tube voltage is constant potential or shows a time

dependent waveform. Non-invasive instruments for the measurement of the X-RAY TUBE

VOLTAGE on the market usually indicate the ‘mean peak voltage’. But the quantity ‘mean peak

voltage’ is not unambiguously defined and may be any mean of all voltage peaks. It is

impossible to establish test procedures for the performance requirements of non-invasive

instruments for the measurement of the X-RAY TUBE VOLTAGE without the definition of the

quantity under consideration. Therefore, this Standard is based on a quantity recently
proposed in the literature to be called "PRACTICAL PEAK VOLTAGE". The PRACTICAL PEAK
VOLTAGE is unambiguously defined and applicable to any waveform. This quantity is related to
the spectral distribution of the emitted X-RADIATION and the image properties. X-RAY
GENERATORS operating at the same value of the PRACTICAL PEAK VOLTAGE will produce the
same low level contrast in the RADIOGRAMS, even when the waveforms of the tube voltages
are different. Detailed information on this concept is provided in Annex B. An example for the
calculation of the PRACTICAL PEAK VOLTAGE in the case of a “falling load” waveform is also
given in Annex B.
As a result of introducing a new quantity, the problem arises that this standard has been
written for instruments which were not explicitly designed for the measurement of the
PRACTICAL PEAK VOLTAGE. However, from preliminary results of a trial type test of a non-
invasive instrument currently on the market, it can be expected that future instruments and
most instruments on the market will be able to fulfil the requirements stated in this standard
without insurmountable difficulties. For the most critical requirements on voltage waveform
and frequency
...