SIST EN IEC 60522-1:2021

SLOVENSKI STANDARD
01-marec-2021
Medicinska električna oprema - Diagnostični rentgenski žarki - 1. del: Določanje
enakovredne kakovosti filtracije in trajne filtracije (IEC 60522-1:2020)
Medical electrical equipment - Diagnostics X-Rays - Part 1: Determination of quality
equivalent filtration and permanent filtration (IEC 60522-1:2020)
Medizinische elektrische Geräte - Röntgendiagnostik - Teil 1: Bestimmung von
qualitätsäquivalenter Filtration und Dauerfiltration (IEC 60522-1:2020)
Appareils électromedicaux - Rayonnements X de diagnostic - Partie 1: Détermination de
la filtration de qualité équivalenteet de la filtration permanente (IEC 60522-1:2020)
Ta slovenski standard je istoveten z: EN IEC 60522-1:2021
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60522-1

NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2021
ICS 11.040.50
English Version
Medical electrical equipment - Diagnostic X-rays - Part 1:
Determination of quality equivalent filtration and permanent
filtration
(IEC 60522-1:2020)
Appareils électromedicaux - Rayonnements X de diagnostic Medizinische elektrische Geräte - Röntgendiagnostik - Teil
- Partie 1: Détermination de la filtration de qualité 1: Bestimmung von qualitätsäquivalenter Filtration und
équivalenteet de la filtration permanente Dauerfiltration
(IEC 60522-1:2020) (IEC 60522-1:2020)
This European Standard was approved by CENELEC on 2021-01-08. 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
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60522-1:2021 E

European foreword
The text of document 62B/1201/FDIS, future edition 1 of IEC 60522-1, prepared by SC 62B
"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60522-1:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-10-08
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-01-08
document have to be withdrawn
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.
Endorsement notice
The text of the International Standard IEC 60522-1:2020 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 60601-2-28:2017 NOTE Harmonized as EN IEC 60601-2-28:2019 (not modified)
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 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety
and essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 —
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety
and essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
- - + corrigendum Mar. 2010
+ A1 2013 + A1 2013
- - + AC 2014
- - + A11 2016
IEC 61674 2012 Medical electrical equipment - EN 61674 2013
Dosimeters with ionization chambers
and/or semiconductor detectors as used
in X-ray diagnostic imaging
IEC/TR 60788 2004 Medical electrical equipment - Glossary - -
of defined terms
To be published. Stage at the time of publication: EN 60601-1:2006/FprA2:2020.
IEC 60522-1 ®
Edition 1.0 2020-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Diagnostic X-rays –

Part 1: Determination of quality equivalent filtration and permanent filtration

Appareils électromedicaux – Rayonnements X de diagnostic –

Partie 1: Détermination de la filtration de qualité équivalenteet de la filtration

permanente
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-9036-1

– 2 – IEC 60522-1:2020 © IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Determination of QUALITY EQUIVALENT FILTRATION . 7
4.1 Alignment of X-RAY TUBE ASSEMBLIES and of the FILTERS . 7
4.2 Generation of the X-RAY BEAM for the determination . 7
4.3 Requirements for RADIATION DETECTOR . 8
4.4 Composition of reference material . 8
4.5 Determination of PERMANENT FILTRATION . 8
4.5.1 Guideline . 8
4.5.2 Direct determination of PERMANENT FILTRATION . 9
4.5.3 Indirect determination of PERMANENT FILTRATION – general case . 10
4.5.4 Indirect determination of PERMANENT FILTRATION – special case . 12
4.6 Determination of the QUALITY EQUIVALENT FILTRATION of a FILTERING MATERIAL
or of a stack of FILTERING MATERIALS . 13
4.6.1 Choice of TARGET ANGLE . 13
4.6.2 Determination method. 13
4.7 X-ray simulations . 15
4.8 Compliance test . 15
5 Indications and statements of QUALITY EQUIVALENT FILTRATION . 15
5.1 Presentation of QUALITY EQUIVALENT FILTRATION values . 15
5.2 Indications and statements of PERMANENT FILTRATION . 15
5.3 Indications and statements of FILTERING MATERIALS . 16
Annex A (informative) Historical background . 17
A.1 General . 17
A.2 The first edition of IEC 60522 (1976) . 17
A.3 The second edition of IEC 60522 (1999) . 17
A.4 The first edition of IEC 60522-1 (2020) . 17
Bibliography . 18
Index of defined terms . 19

Figure 1 – Measurement steps for determining the PERMANENT FILTRATION of an X-RAY
TUBE ASSEMBLY using a reference X-RAY TUBE ASSEMBLY . 9
Figure 2 – Measurement steps for determining the QUALITY EQUIVALENT FILTRATION of a
FILTER – general case . 11
Figure 3 – Measurement steps for determining the QUALITY EQUIVALENT FILTRATION of a
FILTER – special case . 12
Figure 4 – Measurement steps for determining the QUALITY EQUIVALENT FILTRATION of
FILTERING MATERIAL . 14

Table 1 – Overview for the selection of methods for the determination of PERMANENT
FILTRATION and of the QUALITY EQUIVALENT FILTRATION (QEF) . 9

IEC 60522-1:2020 © IEC 2020 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT – DIAGNOSTIC X-RAYS –

Part 1: Determination of quality equivalent
filtration and permanent filtration

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 60522-1 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This first edition cancels and replaces the second edition of IEC 60522 published in 1999. This
edition constitutes a technical revision. This edition includes the following significant technical
changes with respect to the IEC 60522:1999:
The scope of the IEC 60522-1 has been changed with respect to second edition of the
IEC 60522 as follows:
a) As radiotherapy standards do not reference IEC 60522, radiotherapy is no longer in the
scope. Consequently, the HIGH VOLTAGE is limited to 150 kV, and copper is no longer used
as reference material.
– 4 – IEC 60522-1:2020 © IEC 2020
b) While IEC 60522:1999 covers only PERMANENT FILTRATION, IEC 60522-1 also covers quite
generally “material filtering the X-RAY BEAM incident on the PATIENT”. This concerns materials
like ADDED FILTERS, table-tops, a breast COMPRESSION DEVICE, and materials in the BEAM
LIMITING DEVICE. For these materials the defined term FILTERING MATERIAL has been
introduced.
c) In order to provide technical and scientific background and rationale on the content of
IEC 60522-1, IEC TR 60522-2 [2] was introduced.
The text of this document is based on the following documents:
FDIS Report on voting
62B/1201/FDIS 62B/1213/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.
A list of all parts in the IEC 60522 series, published under the general title Medical electrical
equipment – Diagnostic X-rays, can be found on the IEC website.
In this document, the following print types are used:
– requirements and definitions: roman type;
– TERMS DEFINED IN CLAUSE 3 OF THIS DOCUMENT 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.
_____________
Numbers in square brackets refer to the Bibliography.

IEC 60522-1:2020 © IEC 2020 – 5 –
INTRODUCTION
The review of the second edition of IEC 60522 published in 1999 pointed to a number of
technical issues. The analysis of these issues is laid down in the accompanying Technical
Report, IEC TR 60522-2 [2]. This Technical Report identifies those items which are
substantially modified in the first edition of IEC 60522-1 compared with the second edition of
IEC 60522, and elucidates the analyses which led to the many new rationales and new
approaches for the determination of the QUALITY EQUIVALENT FILTRATION.
While the second edition of IEC 60522 covers only PERMANENT FILTRATION, IEC 60522-1 also
covers quite generally “material filtering the X-RAY BEAM incident on the PATIENT”. This concerns
materials like ADDED FILTERS, a PATIENT table, a breast COMPRESSION DEVICE, and materials in
the BEAM LIMITING DEVICE. For these materials the defined term FILTERING MATERIAL has been
introduced.
With the extension by FILTERING MATERIAL, IEC 60522-1 now explicitly covers what IEC 60601-
1-3:2008 requires in its Subclause 7.4 for irremovable materials, i.e.  represented FILTRATION by irremovable materials in an X-RAY SOURCE ASSEMBLY ……. If this
information is not obtainable, determine the QUALITY EQUIVALENT FILTRATION in accordance with
IEC 60522>.
– 6 – IEC 60522-1:2020 © IEC 2020
MEDICAL ELECTRICAL EQUIPMENT – DIAGNOSTIC X-RAYS –

Part 1: Determination of quality equivalent
filtration and permanent filtration

1 Scope
This document applies to X-RAY TUBE ASSEMBLIES and to FILTERING MATERIAL, in medical
diagnostic applications up to a HIGH VOLTAGE of 150 kV. For HIGH VOLTAGES greater than 50 kV,
this document applies to X-RAY TUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only.
NOTE 1 The FILTERING MATERIAL in the X-RAY BEAM can be removable or irremovable; it can be positioned in any
orientation or can have any shape (e.g. tapering thickness) – although usually plane-parallel material, perpendicular
to the REFERENCE AXIS is applied. Examples of FILTERING MATERIALS are ADDED FILTERS, a PATIENT table (in case of
an under-table X-RAY TUBE ASSEMBLY), materials in the BEAM LIMITING DEVICE, or a breast COMPRESSION DEVICE.
NOTE 2 The methodology and statement of compliance given in this document is for flat FILTERS only, but the
methodology can be used for any kind of non-flat FILTER. In that case further data are included in order to produce
useful results, e.g. field size, geometry/position of FILTER, etc.
This document defines the concept of PERMANENT FILTRATION of X-RAY TUBE ASSEMBLIES, and it
defines the term FILTERING MATERIAL.
Methods are given to determine the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY and for
determining the QUALITY EQUIVALENT FILTRATION of FILTERING MATERIALS.
It contains requirements for statements of compliance of X-RAY TUBE ASSEMBLIES in
ACCOMPANYING DOCUMENTS and for markings on X-RAY TUBE ASSEMBLIES, and for indications and
statements of compliance of FILTERING MATERIAL.
NOTE 3 This document does not contain requirements for any specific values of PERMANENT FILTRATION. For X-RAY
EQUIPMENT used for diagnostic purposes, FILTRATION requirements are given in e.g. IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 or in the applicable particular standard.
NOTE 4 The method of determination described in this document is suitable as a type test. It is not intended as a
test to be applied by the USER.
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 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-
ray equipment
IEC 60601-1-3:2008/AMD1:2013
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms

IEC 60522-1:2020 © IEC 2020 – 7 –
IEC 61674:2012, Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-3:2008, IEC 60601-1-
3:2008/AMD1:2013, 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
3.1
FILTERING MATERIAL
material between the X-RAY TUBE ASSEMBLY and the PATIENT which causes FILTRATION of the
X-RAY BEAM
3.2
PERMANENT FILTRATION
QUALITY EQUIVALENT FILTRATION effected in an X-RAY TUBE ASSEMBLY by permanently fixed
materials intercepting the X-RAY BEAM, that are not intended to be removed for any application
and are not provided with means for removal in NORMAL USE
3.3
QUALITY EQUIVALENT FILTRATION
quantitative indication of the FILTRATION effected by one or several layer(s) of reference
RADIATION QUALITY under NARROW BEAM
material(s) which, if substituted in a beam of specified
CONDITION for the material under consideration, give(s) the same RADIATION QUALITY as for the
material under consideration
Note 1 to entry: The QUALITY EQUIVALENT FILTRATION is expressed in suitable submultiples of the metre together
with the reference material(s).
Note 2 to entry: In this document, RADIATION QUALITY is characterized by its first HALF-VALUE LAYER.
[SOURCE IEC 60601-1-3:2008, 3.52, modified – Addition of a new Note 2 to entry.]
4 Determination of QUALITY EQUIVALENT FILTRATION
4.1 Alignment of X-RAY TUBE ASSEMBLIES and of the FILTERS
If, apart from the X-RAY TUBE ASSEMBLY under test, a reference X-RAY TUBE ASSEMBLY is used,
then their REFERENCE AXES shall be aligned.
NOTE The alignment of the REFERENCE AXES is important, as the HALF-VALUE LAYER depends strongly on the
effective TARGET ANGLE. Simulations show, that at the typical mammographic HIGH VOLTAGE of 30 kV, the typical error
in PERMANENT FI
...