Medical electrical equipment - Diagnostics X-Rays - Part 1: Determination of quality equivalent filtration and permanent filtration (IEC 60522-1:2020)

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.

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)

L'IEC 60522-1:2020 s’applique aux GAINES EQUIPEES et au MATERIAU DE FILTRAGE, dans les applications de diagnostic médical soumises à une HAUTE TENSION maximale de 150 kV. Pour les HAUTES TENSIONS supérieures à 50 kV, le présent document s’applique aux GAINES EQUIPEES avec CIBLES en tungstène ou en alliage de tungstène uniquement. L'IEC 60522-1:2020 définit le concept de FILTRATION PERMANENTE des GAINES EQUIPEES ainsi que le terme MATERIAU DE FILTRAGE. Des méthodes sont données pour déterminer la FILTRATION PERMANENTE d’UNE GAINE EQUIPEE ainsi que la FILTRATION DE QUALITE EQUIVALENTE des MATERIAUX DE FILTRAGE. Il comprend des exigences relatives aux déclarations de conformité des GAINES EQUIPEES dans les DOCUMENTS D’ACCOMPAGNEMENT et aux marquages sur les GAINES EQUIPEES, ainsi qu’aux indications et déclarations de conformité du MATERIAU DE FILTRAGE. L'IEC 60522-1:2020 annule et remplace la seconde édition de l’IEC 60522 parue en 1999. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l’IEC 60522:1999. Le domaine d’application de l’IEC 60522-1 a été modifié par rapport à la deuxième édition de l’IEC 60522 comme suit: a) Les normes de radiothérapie ne faisant pas référence à l’IEC 60522, la radiothérapie ne fait plus partie du domaine d’application. Par conséquent, la HAUTE TENSION est limitée à 150 kV et le cuivre n’est plus utilisé comme matériau de référence. b) Alors que l’IEC 60522:1999 traite uniquement de la FILTRATION PERMANENTE, l’IEC 60522 1 traite également de façon plus générale du "matériau filtrant le FAISCEAU DE RAYONNEMENT X incident sur le PATIENT". Ceci concerne des matériaux tels que des FILTRES ADDITIONNELS, des plateaux de table, un DISPOSITIF DE COMPRESSION du sein et des matériaux présents dans le LIMITEUR DE FAISCEAU. Le terme défini de MATERIAU DE FILTRAGE est employé pour désigner ces matériaux. c) L’IEC TR 60522-2 a été ajouté afin de fournir un contexte et une justification techniques et scientifiques sur le contenu de l’IEC 60522-1.

Medicinska električna oprema - Diagnostični rentgenski žarki - 1. del: Določanje enakovredne kakovosti filtracije in trajne filtracije (IEC 60522-1:2020)

General Information

Status
Published
Publication Date
01-Feb-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
29-Jan-2021
Due Date
05-Apr-2021
Completion Date
02-Feb-2021

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SLOVENSKI STANDARD
SIST EN IEC 60522-1:2021
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
SIST EN IEC 60522-1:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60522-1:2021
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SIST EN IEC 60522-1:2021
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
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SIST EN IEC 60522-1:2021
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)
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SIST EN IEC 60522-1:2021
EN IEC 60522-1:2021 (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 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.
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SIST EN IEC 60522-1:2021
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SIST EN IEC 60522-1:2021
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

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 60522-1:2021
– 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

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SIST EN IEC 60522-1:2021
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.
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SIST EN IEC 60522-1:2021
– 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.
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SIST EN IEC 60522-1:2021
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>.
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SIST EN IEC 60522-1:2021
– 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
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SIST EN IEC 60522-1:2021
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 FILTRATION is of the order of 1,5 % per one-degree misalignment. At the typical radiographic HIGH

VOLTAGE of 75 kV, it is of the order of 4 %.

Unless otherwise stated, the FILTERS are positioned perpendicular to the REFERENCE AXIS.

4.2 Generation of the X-RAY BEAM for the determination
The PERCENTAGE RIPPLE shall not be larger than 10 %.

It is recommended to limit the PERCENTAGE RIPPLE to 4 %, in order to maintain accuracy,

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SIST EN IEC 60522-1:2021
– 8 – IEC 60522-1:2020 © IEC 2020
– if the HIGH VOLTAGE is smaller than 50 kV, or

– if the HIGH VOLTAGE is larger than 50 kV and if the atomic number of the FILTERS is larger

than 30, or

– if the HIGH VOLTAGE is larger than 50 kV and the atomic number of the FILTERS is not larger

than 30, while the sum of the QUALITY EQUIVALENT FILTRATION of all materials with atomic

number not larger than 26 is smaller than 0,5 mm Al.

The HIGH VOLTAGE shall be kept constant during all the steps in the determination.

NOTE Stability of the HIGH VOLTAGE during the determination is important, as the HALF-VALUE LAYER depends

strongly on the HIGH VOLTAGE. HIGH VOLTAGE-shift of the order of 1 % in one of the steps of the determination can

lead to an error in the determined value of the QUALITY EQUIVALENT FILTRATION of the order of 10 %.

Unless other standards prescribe the HIGH VOLTAGE, the following values of the HIGH VOLTAGE

are recommended:
– for mammographic applications, 28 kV,
– for dental applications, 60 kV,
– for any other application, 75 kV,

– unless the application does not include 75 kV or is centred outside 75 kV; then it is

recommended to apply a HIGH VOLTAGE in the range of the application.
4.3 Requirements for RADIATION DETECTOR

An AIR KERMA RATE RADIATION DETECTOR shall be used which complies with the requirements of

IEC 61674:2012 for the beam qualities seen by the detector during the QUALITY EQUIVALENT

FILTRATION-determination.

NOTE This requirement ensures that the detector used has a sufficiently flat AIR KERMA RATE response.

4.4 Composition of reference material

Values of HALF-VALUE LAYER and QUALITY EQUIVALENT FILTRATION determined in accordance with

this document apply to the reference material aluminium with 99,9 % purity or higher and density

2,70 g/cm .
4.5 Determination of PERMANENT FILTRATION
4.5.1 Guideline

NOTE For guidance and overview, Table 1 serves to support selecting the appropriate method for determining the

QUALITY EQUIVALENT FILTRATION. It does not replace the text of the paragraphs 4.5.2 to 4.5.4, which are to be

referenced to take the final decision on the method to be applied.
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SIST EN IEC 60522-1:2021
IEC 60522-1:2020 © IEC 2020 – 9 –

Table 1 – Overview for the selection of methods for the determination of PERMANENT

FILTRATION
Object under test Method for X-ray source(s) required HIGH VOLTAGE Figure
PERMANENT number
FILTRATION
Original X-RAY TUBE
ASSEMBLY with PERMANENT
X-RAY TUBE ASSEMBLY with
direct FILTRATION and X-RAY TUBE ≤150 kV Figure 1
PERMANENT FILTRATION
ASSEMBLY with minimal
FILTRATION
(Stack of) PERMANENT X-RAY TUBE ASSEMBLY with
indirect ≤150 kV Figure 2
FILTRATION materials minimal FILTRATION
Separate individual
Reference X-RAY TUBE
FILTER(S) or stack(s) of
ASSEMBLY whose X-RAY BEAM
FILTERS comprising the ≥50 kV and
indirect is only filtered by materials Figure 3
PERMANENT FILTRATION, the ≤150 kV
with Z ≤ 26, with a QEF of at
QEF-values of which can
least 0,5 mm Al
reliably be added
4.5.2 Direct determination of PERMANENT FILTRATION

For the direct determination, i.e. while applying a reference X-RAY TUBE ASSEMBLY with minimal

PERMANENT FILTRATION, the measurement arrangement indicated in Figure 1, is used.

Figure 1 – Measurement steps for determining the PERMANENT FILTRATION of an X-RAY

TUBE ASSEMBLY using a reference X-RAY TUBE ASSEMBLY
Steps for determining the PERMANENT FILTRATION:
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SIST EN IEC 60522-1:2021
– 10 – IEC 60522-1:2020 © IEC 2020

1a With the X-RAY TUBE ASSEMBLY under test, measure the AIR KERMA RATE 𝐾𝐾̇ at a fixed

reference HIGH VOLTAGE under the conditions stated in 4.2, using a suitable RADIATION

DETECTOR (D) as described in 4.3.

1b Using an iterative measurement process, determine the HALF-VALUE LAYER referenced to

aluminium of the X-RAY BEAM by adding aluminium reference FILTERS (R) into the beam

until the AIR KERMA RATE is halved from the value determined in step 1a.

1c Substitute a reference X-RAY TUBE ASSEMBLY with minimal PERMANENT FILTRATION (e.g. a

beryllium window X-RAY TUBE ASSEMBLY with all intervening layers of material in the X-

RAY BEAM removed) in place of the X-RAY TUBE ASSEMBLY under test. The
...

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