SIST EN IEC 60580:2020

SLOVENSKI STANDARD
SIST EN IEC 60580:2020
01-junij-2020
Nadomešča:
SIST EN 60580:2002
Medicinska električna oprema - Merilniki produkta površina-doza (IEC 60580:2019)
Medical electrical equipment - Dose area product meters (IEC 60580:2019)
Medizinische elektrische Geräte - Dosisflächenprodukt-Messgeräte (IEC 60580:2019)
Appareils électromédicaux - Radiamètres de produit exposition-surface (IEC
60580:2019)
Ta slovenski standard je istoveten z: EN IEC 60580:2020
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.240 Merjenje sevanja Radiation measurements
SIST EN IEC 60580:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60580:2020

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SIST EN IEC 60580:2020


EUROPEAN STANDARD EN IEC 60580

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2020
ICS 11.040.50 Supersedes EN 60580:2000 and all of its amendments
and corrigenda (if any)
English Version
Medical electrical equipment - Dose area product meters
(IEC 60580:2019)
Appareils électromédicaux - Radiamètres de produit Medizinische elektrische Geräte - Dosisflächenprodukt-
exposition-surface Messgeräte
(IEC 60580:2019) (IEC 60580:2019)
This European Standard was approved by CENELEC on 2019-12-17. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60580:2020 E

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SIST EN IEC 60580:2020
EN IEC 60580:2020 (E)
European foreword
The text of document 62C/744/FDIS, future edition 3 of IEC 60580, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 60580:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
document have to be withdrawn

This document supersedes EN 60580:2000 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association.
Endorsement notice
The text of the International Standard IEC 60580:2019 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60731:2011 NOTE Harmonized as EN 60731:2012 (not modified)

2

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SIST EN IEC 60580:2020
EN IEC 60580:2020 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60417-1 -  Graphical symbols for use on equipment_- - -
Part_1: Overview and application
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
  +A12 2014
  +EN 60601-2010
1:2006/corrigendum
Mar. 2010
  +AC 2014
  +A11 2011
IEC 60601-1-2 -  Medical electrical equipment - Part 1-2: EN 60601-1-2 -
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 61000-4-2 -  Electromagnetic compatibility (EMC) - PartE N 61000-4-2 -
4-2: Testing and measurement techniques
- Electrostatic discharge immunity test
IEC 61000-4-3 -  Electromagnetic compatibility (EMC) -- PartE N 61000-4-3 -
4-3: Testing and measurement techniques
- Radiated, radio-frequency,
electromagnetic field immunity test
IEC 61000-4-4 -  Electromagnetic compatibility (EMC) -- PartE N 61000-4-4 -
4-4: Testing and measurement techniques
- Electrical fast transient/burst immunity
test
IEC 61000-4-5 -  Electromagnetic compatibility (EMC) - PartE N 61000-4-5 -
4-5: Testing and measurement techniques
- Surge immunity test
IEC 61000-4-6 -  Electromagnetic compatibility (EMC) - PartE N 61000-4-6 -
4-6: Testing and measurement techniques
- Immunity to conducted disturbances,
induced by radio-frequency fields
3

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SIST EN IEC 60580:2020
EN IEC 60580:2020 (E)
Publication Year Title EN/HD Year
IEC 61000-4-11 -  Electromagnetic compatibility (EMC) - PartEN IEC 61000-4-11 -
4-11: Testing and measurement
techniques - Voltage dips, short
interruptions and voltage variations
immunity tests for equipment with input
current up to 16 A per phase
IEC 61185 -  Ferrite cores (ETD-cores) intended for use EN 61185 -
in power supply applications - Dimensions
IEC 61267 -  Medical diagnostic X-ray equipment - EN 61267 -
Radiation conditions for use in the
determination of characteristics
IEC 62368-1 -  Audio/video, information and EN IEC 62368-1 -
communication technology equipment -
Part 1: Safety requirements
  +prAB
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms

4

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SIST EN IEC 60580:2020



IEC 60580

®


Edition 3.0 2019-11




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Medical electrical equipment – Dose area product meters



Appareils électromédicaux – Radiamètres de produit exposition-surface



















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.040.50 ISBN 978-2-8322-7591-7




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN IEC 60580:2020
– 2 – IEC 60580:2019 © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 General requirements . 14
4.1 Performance requirements . 14
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 . 15
4.5.1 STANDARD TEST CONDITIONS . 15
4.5.2 Test of components . 15
4.5.3 STABILIZATION TIME . 15
4.5.4 Adjustments during test . 16
4.5.5 Uniformity of RADIATION field . 16
4.6 Statistical fluctuations . 16
4.7 Uncertainty of measurement . 17
4.8 Constructional requirements as related to performance . 17
4.8.1 Display . 17
4.8.2 Indication of polarizing voltage failure . 17
4.8.3 Over-ranging . 17
4.8.4 Indication of reset or other inactive condition . 18
4.8.5 RADIATION DETECTOR . 18
4.9 STABILITY CHECK DEVICE . 18
4.10 Adjustment . 19
4.11 Electrical safety . 20
5 Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST CONDITIONS . 20
5.1 Classification of DOSE AREA PRODUCT METERS according to LIMITS OF
VARIATION . 20
5.1.1 REFERENCE-CLASS DOSE AREA PRODUCT METERS . 20
5.1.2 FIELD-CLASS DOSE AREA PRODUCT METERS . 20
5.2 LINEARITY . 20
5.3 Warning function . 20
5.4 Repeatability . 21
5.5 RESOLUTION of reading . 21
5.6 STABILIZATION TIME . 21
5.7 Reset on DOSE AREA PRODUCT ranges . 21
5.8 Drift of INDICATED VALUES . 21
5.9 Long term stability . 22
5.10 RESPONSE TIME . 22
5.11 Spatial uniformity of RESPONSE . 23
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 23
6.1 General . 23
6.2 Energy dependence of RESPONSE . 23

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IEC 60580:2019 © IEC 2019 – 3 –
6.3 DOSE AREA PRODUCT RATE dependence of DOSE AREA PRODUCT measurements. 23
6.3.1 MEASURING ASSEMBLY . 23
6.3.2 IONIZATION CHAMBER – Recombination losses . 24
6.4 IRRADIATION TIME . 24
6.5 Field size . 24
6.6 Operating voltage . 24
6.7 Air pressure . 25
6.8 Temperature and humidity . 25
6.9 Air density fluctuation in the IONIZATION CHAMBER . 25
6.10 Electromagnetic compatibility . 25
6.10.1 General . 25
6.10.2 Electrostatic discharge . 26
6.10.3 Radiated electromagnetic fields . 26
6.10.4 Conducted disturbances induced by bursts and high frequencies . 26
6.10.5 Surges . 27
6.10.6 Voltage dips, short interruptions and voltage VARIATIONS . 27
6.11 COMBINED STANDARD UNCERTAINTY . 27
7 Marking . 29
7.1 MEASURING ASSEMBLY . 29
7.2 RADIATION DETECTOR . 30
8 ACCOMPANYING DOCUMENTS . 30
Bibliography . 32
INDEX OF DEFINED TERMS . 33

Table 1 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT . 14
Table 2 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT RATE . 14
Table 3 – REFERENCE VALUES and STANDARD TEST CONDITIONS . 15
Table 4 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 16
Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 19
Table 6 – Maximum values for the COEFFICIENT OF VARIATION, V . 21
max
Table 7 – Climatic conditions . 25
Table 8 – Example for assessment of the COMBINED STANDARD UNCERTAINTY – FIELD-
CLASS DOSE AREA PRODUCT METER . 28
Table 9 – Example for assessment of the COMBINED STANDARD UNCERTAINTY –
REFERENCE-CLASS DOSE AREA PRODUCT METER . 29

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –
DOSE AREA PRODUCT METERS

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.
International Standard IEC 60850 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 third edition cancels and replaces the second edition published 2000, and constitutes a
technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) a second class of devices is introduced with tighter uncertainty tolerances;
b) this document has been expanded to include detectors other than ionization chambers;
c) radiation qualities have been updated to the new definitions according to IEC 61267;
d) a requirement on the linearity of the dose area product rate measurement was added;
e) changed chamber light transmission requirement from 70 % to 60 %.

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SIST EN IEC 60580:2020
IEC 60580:2019 © IEC 2019 – 5 –
The text of this International Standard is based on the following documents:
FDIS Report on voting
62C/744/FDIS 62C/751/RVD

Full information on the voting for the approval of this International Standard 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.
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 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.

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INTRODUCTION
Diagnostic radiology is the largest contributor to man-made ionizing radiation to which the
public is exposed. The reduction in the exposure received by PATIENTS undergoing MEDICAL
RADIOLOGICAL EXAMINATIONS or procedures has therefore become a central issue in recent
years. The purpose of routine measurement of DOSE AREA PRODUCT is to help in achieving an
overall reduction in the radiation received by PATIENTS undergoing MEDICAL RADIOLOGICAL
EXAMINATIONS. Provided adequate records are kept, it is possible to determine PATIENT doses,
to compare different examination techniques, to establish a technique giving minimum
RADIATION to a PATIENT, and to ensure a maintenance of that technique; in this respect, such
measurements have a place of particular importance in training establishments. Examination
of records may also indicate a deterioration in the efficiency of the image-production system.

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IEC 60580:2019 © IEC 2019 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
DOSE AREA PRODUCT METERS



1 Scope
This document specifies the performance and testing of DOSE AREA PRODUCT METERS intended
to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is
during MEDICAL RADIOLOGICAL EXAMINATIONS.
exposed
This document is applicable to the following types of DOSE AREA PRODUCT METERS:
FIELD-CLASS DOSE AREA PRODUCT METERS normally used for the measurement of DOSE AREA
a)
PRODUCTS during MEDICAL RADIOLOGICAL EXAMINATIONS;
b) REFERENCE-CLASS DOSE AREA PRODUCT METERS normally used for the CALIBRATION of FIELD-
CLASS DOSIMETERS.
NOTE REFERENCE-CLASS DOSE AREA PRODUCT METERS can be used as FIELD-CLASS DOSE AREA PRODUCT
METERS.
The object of this document 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.
Two levels of performance are specified:
– a lower level of performance applying to FIELD-CLASS DOSE AREA PRODUCT METERS;
– a higher level of performance applying to REFERENCE-CLASS DOSE AREA PRODUCT METERS.
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 60417, Graphical symbols for use on equipment (available at http://www.graphical-
symbols.info/equipment)
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 62368-1, Audio/video, information and communication technology equipment – Part 1:
Safety requirements

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IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement
techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement
techniques – Electrical fast transient/burst immunity test
IEC 61000-4-5, Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement
techniques – Surge immunity test
IEC 61000-4-6, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement
techniques – Immunity to conducted disturbances induced by radio-frequency fields
IEC 61000-4-11, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement
techniques – Voltage dips, short interruptions and voltage variations immunity tests
IEC 61187, Electrical and electronic measuring equipment – Documentation
IEC 61267, Medical diagnostic X-ray equipment – Radiation conditions for use in the
determination of characteristics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC
TR 60788:2004 and the following 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 1 An index of defined terms is to be found at the end of the document.
NOTE 2 A searchable IEC Glossary can be found at std.iec.ch.
3.1
ACCOMPANYING DOCUMENT
document provided with an installation, equipment, associated equipment or accessory,
containing important information for the assembler, installer and user, particularly regarding
safety
3.2
AIR KERMA
K
quotient of dE by dm, where dE is the sum of the initial kinetic energies of all the charged
tr tr
particles in a mass dm of air, thus
dE
tr
K=
dm
–1
Note 1 to entry: Unit: J kg .
Note 2 to entry: The special name for the unit of AIR KERMA is gray (Gy) (ICRU 85A).

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IEC 60580:2019 © IEC 2019 – 9 –
3.3
AIR KERMA RATE

K
quotient of dK by dt, where dK is the increment of AIR KERMA in the time interval dt, thus

dK
K
=
dt
–1 –1

Note 1 to entry: Unit: J kg s .
–1
Note 2 to entry: The special name for the unit of AIR KERMA rate is gray per second (Gy s ) (ICRU 85A).
3.4
COEFFICIENT OF VARIATION
standard deviation of a set of readings expressed as a percentage of the mean value of these
readings
3.5
CORRECTION FACTOR
INDICATED VALUE of an instrument from its value
dimensionless multiplier which corrects the
when operated under particular conditions to its value when operated under stated REFERENCE
CONDITIONS
[SOURCE: IEC 60731:2011, 3.6]
3.6
DOSE AREA PRODUCT
K·A
product of the area of the USEFUL BEAM and the AIR KERMA over t
...