EN IEC 60522-1:2021
(Main)Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration
Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration
IEC 60522-1:2020 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. IEC 60522-1:2021 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. IEC 60522-1:2020 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. 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 was introduced.
Medizinische elektrische Geräte - Röntgendiagnostik - Teil 1: Bestimmung von qualitätsäquivalenter Filtration und Dauerfiltration
Appareils électromedicaux - Rayonnements X de diagnostic - Partie 1: Détermination de la filtration de qualité équivalenteet de la filtration permanente
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
Relations
Standards Content (Sample)
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
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same status as the official versions.
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Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
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© 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
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