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

Status
Published
Publication Date
26-Sep-2019
Withdrawal Date
06-Aug-2022
Current Stage
6060 - Document made available - Publishing
Start Date
27-Sep-2019
Completion Date
27-Sep-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-28:2020
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
SIST EN IEC 60601-2-28:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-28:2020

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SIST EN IEC 60601-2-28:2020


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

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SIST EN IEC 60601-2-28:2020
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
...

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