IEC 60580:2000

Medical electrical equipment - Dose area product meters

Specifies the performance and testing of dose area product meters with ionization chambers intended to measure dose area product and/or dose area product rate to which the patient is exposed during medical radiological examinations. The object of this International Standard is 1) to establish requirements for a satisfactory level of performance for dose area product meters, and 2) to standardize the methods for the determination of compliance with this level of performance.

Appareils électromédicaux - Radiamètres de produit exposition-surface

Spécifie la performance et l'essai des radiamètres de produit exposition-surface avec chambres d'ionisation destinés à la mesure du produit exposition-surface et/ou du débit de produit exposition-surface auquel le patient est exposé au cours des examens radiologiques médicaux. L'objet de cette Norme internationale est 1) d'établir les critères pour assurer un niveau de performance satisfaisant des radiamètres de produit exposition-surface, et 2) de normaliser les méthodes pour déterminer la conformité à ce niveau de performance.

General Information

• Status: Published
• Publication Date: 13-Jan-2000
• ICS: 11.040.50 - Radiographic 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: 03-Mar-2017
• Completion Date: 12-Nov-2019

Relations

• Revised: IEC 60580:2019 - Medical electrical equipment - Dose area product meters
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
Second edition
2000-01
Medical electrical equipment –
Dose area product meters
Appareils électromédicaux –
Radiamètres de produit exposition-surface

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. 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.

Validity of this publication
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 the date of the reconfirmation of the publication is available
in the IEC catalogue.
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 to be found at the following IEC sources:
• IEC web site*
• Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
Second edition
2000-01
Medical electrical equipment –
Dose area product meters
Appareils électromédicaux –
Radiamètres de produit exposition-surface

 IEC 2000  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
V
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60580 © IEC:2000(E)
CONTENTS
Page
FOREWORD . 4

INTRODUCTION .6

Clause
1 Scope and object . 7

2 Normative references. 7

3 Terminology and definitions . 8
4 General requirements . 13
4.1 Performance requirements. 13
4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT and DOSE AREA PRODUCT RATE 14
4.3 Plane of measurement . 14
4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS . 14
4.5 General test conditions . 14
STANDARD TEST CONDITIONS
4.5.1 . 14
4.5.2 Test of components. 14
4.5.3 STABILIZATION TIME . 14
4.5.4 Adjustments during test. 15
4.5.5 Uniformity of radiation field . 15
4.6 Statistical fluctuations . 15
4.7 Uncertainty of measurement . 15
4.8 Constructional requirements as related to performance. 15
4.8.1 Display. 15
4.8.2 Indication of polarizing voltage failure . 16
4.8.3 Over-ranging. 16
4.8.4 Indication of reset or other inactive condition . 16
IONIZATION CHAMBER
4.8.5 . 16
4.9 STABILITY CHECK DEVICE . 17
4.10 Adjustment. 17
4.11 Electrical safety . 17
5 Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST CONDITIONS. 18
5.1 RELATIVE INTRINSIC ERROR. 18

5.2 Warning function. 18
5.3 Repeatability. 19
5.4 RESOLUTION of reading . 19
5.5 STABILIZATION TIME. 19
DOSE AREA PRODUCT
5.6 Reset on ranges. 19
5.7 Drift of INDICATED VALUES. 19
5.8 Long term stability . 20
5.9 RESPONSE TIME . 20
5.10 Spatial uniformity of RESPONSE. 20

60580 © IEC:2000(E) – 3 –
Clause Page
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES. 21

6.1 Energy dependence of RESPONSE. 21

6.2 DOSE AREA PRODUCT RATE dependence of DOSE AREA PRODUCT measurements . 21

MEASURING ASSEMBLY
6.2.1 . 21

6.2.2 IONIZATION CHAMBER – Recombination losses. 21

6.3 IRRADIATION TIME . 22

6.4 Field size . 22

6.5 Operating voltage . 22

6.6 Air pressure . 22
6.7 Temperature and humidity . 22
6.8 Air density fluctuation in the IONIZATION CHAMBER . 23
6.9 Electromagnetic compatibility. 23
6.9.1 General. 23
6.9.2 Electrostatic discharge. 23
6.9.3 Radiated electromagnetic fields . 24
6.9.4 Conducted disturbances induced by bursts and high frequencies . 24
6.9.5 Surges . 24
6.9.6 Voltage dips, short interruptions and voltage VARIATIONS. 24
6.10 COMBINED STANDARD UNCERTAINTY. 25
7 Marking. 25
7.1 MEASURING ASSEMBLY . 25
7.2 IONIZATION CHAMBER . 25
8ACCOMPANYING DOCUMENTS . 25
Table 1 – Minimum EFFECTIVE RANGES . 27
Table 2 – REFERENCE VALUES and STANDARD TEST CONDITIONS . 27
Table 3 – Number of readings required to detect true differences Δ
(95 % confidence level) between two sets of instrument readings. 28
Table 4 – RELATIVE INSTRINSIC ERROR, I. 28
Table 5 – Maximum values for the COEFFICIENT OF VARIATION, V . 28
max
Table 6 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES. 29
Table 7 – Example for assessment of the COMBINED STANDARD UNCERTAINTY. 30

Bibliography . 31
Index of defined terms.32

– 4 – 60580 © IEC:2000(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION

–––––––––––
MEDICAL ELECTRICAL EQUIPMENT –

DOSE AREA PRODUCT METERS
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 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 60580 has been prepared by sub-committee 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 1977, and constitutes a
technical revision.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/272/FDIS 62C/275/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.
A bilingual version of this publication may be issued at a later date.

60580 © IEC:2000(E) – 5 –
In this standard, the following print types are used:

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

– explanations, advice, general statements, exceptions and references: small roman type;

– test specifications: italic type;

– TERMS USED THROUGHOUT THIS STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 3 OR LISTED IN

THE INDEX: SMALL CAPITALS.
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.
– 6 – 60580 © IEC:2000(E)
...

IEC 60580
Edition 2.0 2000-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dose area product meters

Appareils électromédicaux – Radiamètres de produit exposition-surface

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.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.

Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette

publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: 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.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: [e-mail]
Tel.: [phone]
Fax: [phone]
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: [e-mail]
Tél.: [phone]
Fax: [phone]
IEC 60580
Edition 2.0 2000-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dose area product meters

Appareils électromédicaux – Radiamètres de produit exposition-surface

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
V
CODE PRIX
ICS 11.040.50 ISBN 2-8318-7178-6
– 2 – 60580 © CEI:2000
SOMMAIRE
AVANT-PROPOS.6

INTRODUCTION.10

1 Domaine d’application et objet.12

2 Références normatives.12

3 Terminologie et définitions.14

4 Prescriptions générales.26

4.1 Prescriptions de performance.26
4.2 DOMAINES UTILES minimaux de PRODUIT EXPOSITION-SURFACE et de DÉBIT
DE PRODUIT EXPOSITION-SURFACE .26
4.3 Plan de mesurage .26
4.4 VALEURS DE RÉFÉRENCE et CONDITIONS D'ESSAI NORMALISÉES .26
4.5 Conditions générales d’essai.26
4.5.1 CONDITIONS D'ESSAI NORMALISÉES.26
4.5.2 Essai des composants.28
4.5.3 TEMPS DE STABILISATION.28
4.5.4 Réglages en cours d’essai.28
4.5.5 Uniformité du champ de rayonnement.28
4.6 Fluctuations statistiques.30
4.7 Incertitude de la mesure.30
4.8 Règles de construction liées aux performances .30
4.8.1 Affichage.30
4.8.2 Indication d’un défaut de tension de polarisation .32
4.8.3 Dépassement de l’étendue de mesure .32
4.8.4 Indication de réinitialisation ou autre état d’inactivité .32
4.8.5 CHAMBRE D’IONISATION .32
4.9 CONTROLEUR DE CONSTANCE .34
4.10 Réglage.34
4.11 Sécurité électrique.34
5 Limites des CARACTÉRISTIQUES DE PERFORMANCE sous CONDITIONS D'ESSAI
NORMALISÉES.34
5.1 ERREUR INTRINSÈQUE RELATIVE.34
5.2 Fonction d’alarme.36

5.3 Répétabilité.36
5.4 POUVOIR DE RÉSOLUTION de lecture .38
5.5 TEMPS DE STABILISATION.38
5.6 Réinitialisation des plages de PRODUIT EXPOSITION-SURFACE .38
5.7 Dérive des VALEUR INDIQUÉES.38
5.8 Stabilité à long terme .40
5.9 TEMPS DE RÉPONSE .40
5.10 Uniformité spatiale de la RÉPONSE .42
6 LIMITES DE VARIATION pour les effets des GRANDEURS D’INFLUENCE.42
6.1 Dépendance de l’énergie de la RÉPONSE.42
6.2 Dépendance des mesures de PRODUIT EXPOSITION-SURFACE du DÉBIT DE
PRODUIT EXPOSITION-SURFACE.42
6.2.1 ENSEMBLE DE MESURAGE .42
6.2.2 CHAMBRE D’IONISATION – pertes de recombinaison .42

60580 © IEC:2000 – 3 –
CONTENTS
FOREWORD.7

INTRODUCTION.11

1 Scope and object.13

2 Normative references.13

3 Terminology and definitions.15

4 General requirements .27
4.1 Performance requirements .27
4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT and DOSE AREA PRODUCT
RATE .27
4.3 Plane of measurement.27
4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS.27
4.5 General test conditions.27
4.5.1 STANDARD TEST CONDITIONS .27
4.5.2 Test of components.29
4.5.3 STABILIZATION TIME .29
4.5.4 Adjustments during test .29
4.5.5 Uniformity of radiation field.29
4.6 Statistical fluctuations .31
4.7 Uncertainty of measurement.31
4.8 Constructional requirements as related to performance .31
4.8.1 Display.31
4.8.2 Indication of polarizing voltage failure.33
4.8.3 Over-ranging.33
4.8.4 Indication of reset or other inactive condition.33
4.8.5 IONIZATION CHAMBER .33
4.9 STABILITY CHECK DEVICE.35
4.10 Adjustment.35
4.11 Electrical safety.35
5 Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST CONDITIONS .35
5.1 RELATIVE INTRINSIC ERROR .35
5.2 Warning function.37

5.3 Repeatability.37
5.4 RESOLUTION of reading.39
5.5 STABILIZATION TIME .39
5.6 Reset on DOSE AREA PRODUCT ranges .39
5.7 Drift of INDICATED VALUES .39
5.8 Long term stability.
...