EN IEC 60601-2-28:2019
(Main)Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.
Medizinische elektrische Geräte - Teil 2-28: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgenstrahlern für die medizinische Diagnostik
Appareils électromédicaux - Partie 2-28 : Exigences particulières pour la sécurité de base et les performances essentielles des gaines équipées pour diagnostic médical
La CEI 60601-2-28:2010 établit des exigences particulières relatives à la sécurité de base et aux performances essentielles des gaines équipées pour diagnostic médical. Cette deuxième édition annule et remplace la première édition parue en 1993. La présente édition constitue une révision technique. La seconde édition de la présente norme particulière a été établie pour correspondre à la CEI 60601-1:2005 (la troisième édition de la CEI 60601-1), qui est désignée comme la norme générale.
Medicinska električna oprema - 2-28. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih sestavov za medicinsko diagnostiko (IEC 60601-2-28:2017)
Standard IEC 60601-2-28:2010 določa posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih sestavov za medicinsko diagnostiko. Druga izdaja razveljavlja in nadomešča prvo izdajo, objavljeno leta 1993. Ta izdaja je tehnično popravljena izdaja. Ta druga izdaja tega standarda je bila pripravljena tako, da se ujema s standardom IEC 60601-1:2005 (tretjo izdajo standarda IEC 60601-1), ki se uporablja kot splošni standard.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2020
Nadomešča:
SIST EN 60601-2-28:2010
Medicinska električna oprema - 2-28. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenskih sestavov za medicinsko diagnostiko (IEC 60601-2-
28:2017)
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and
essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-
28:2017)
Medizinische elektrische Geräte - Teil 2-28: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgenstrahlern für die
medizinische Diagnostik (IEC 60601-2-28:2017)
Appareils électromédicaux - Partie 2-28 : Exigences particulières pour la sécurité de
base et les performances essentielles des gaines équipées pour diagnostic médical (IEC
60601-2-28:2017)
Ta slovenski standard je istoveten z: EN IEC 60601-2-28:2019
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-28
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2019
ICS 11.040.55 Supersedes EN 60601-2-28:2010 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-28: Particular requirements
for the basic safety and essential performance of X-ray tube
assemblies for medical diagnosis
(IEC 60601-2-28:2017)
Appareils électromédicaux - Partie 2-28 : Exigences Medizinische elektrische Geräte - Teil 2-28: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des gaines équipées pour diagnostic médical wesentlichen Leistungsmerkmale von Röntgenstrahlern für
(IEC 60601-2-28:2017) die medizinische Diagnostik
(IEC 60601-2-28:2017)
This European Standard was approved by CENELEC on 2019-08-07. 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-28:2019 E
European foreword
The text of document 62B/1040/FDIS, future edition 3 of IEC 60601-2-28, 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 60601-2-
28:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-05-07
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-08-07
document have to be withdrawn
This document supersedes EN 60601-2-28:2010.
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 60601-2-28:2017 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010 (not modified)
ISO 13732-1 NOTE Harmonized as EN ISO 13732-1
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.
The annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Addition
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots
IEC 60522 - Determination of the permanent filtration of EN 60522 -
X-ray tube assemblies
IEC TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
Replacement
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
+EN 60601-1-2010
3:2008/corrigendum
Mar. 2010
+A11 2016
IEC 60601-2-28 ®
Edition 3.0 2017-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-28: Particular requirements for the basic safety and essential performance
of X-ray tube assemblies for medical diagnosis
Appareils électromédicaux –
Partie 2-28: Exigences particulières pour la sécurité de base et les performances
essentielles des gaines équipées pour diagnostic médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-4288-9
– 2 – IEC 60601-2-28:2017 IEC 2017
CONTENTS
FOREWORD . 3
201. 1 Scope, object and related standards . 5
201. 2 Normative references . 6
201. 3 Terms and definitions . 7
201. 4 General requirements . 7
201. 5 General requirements for testing ME EQUIPMENT . 8
201. 6 Classification of ME EQUIPMENT and ME SYSTEMS . 8
201. 7 ME EQUIPMENT identification, marking and documents . 9
201. 8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201. 9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201. 10 Protection against unwanted and excessive RADIATION HAZARDS . 15
201. 11 Protection against excessive temperatures and other HAZARDS . 15
201. 12 Accuracy of controls and instruments and protection against hazardous
outputs . 16
201. 13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 16
201. 14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
201. 15 Construction of ME EQUIPMENT . 17
201. 16 ME SYSTEMS . 17
201. 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 17
203 RADIATION protection in diagnostic X-RAY EQUIPMENT. 18
Annexes . 20
Annex AA (informative) Test of X-RAY TUBE ASSEMBLIES for expelled parts-related
and/or tube implosion-related RISKS . 20
Bibliography . 22
Index of defined terms used in this particular standard . 23
IEC 60601-2-28:2017 IEC 2017 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-28: Particular requirements for the basic safety
and essential performance of X-ray tube assemblies for medical diagnosis
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
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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 60601-2-28 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This third edition cancels and replaces the second edition published in 2010. This edition
constitutes a technical revision.
The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred
to as the
...
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