EN 60601-2-28:2010

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 éléctromédicaux - 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 naprav za zdravniške preglede (IEC 60601-2-28:2010)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI RENGENTSKIH NAPRAV in njihovih komponent: - v nadaljevanju ME OPREMO; - namenjeno za zdravniške preglede in slikanje. Če je klavzula ali podklavzula izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. V nasprotnem primeru, tako klavzula ali podklavzula veljata za ustrezno ME OPREMO in ME SISTEME.

General Information

• Status: Withdrawn
• Publication Date: 06-May-2010
• Withdrawal Date: 31-Mar-2013
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 07-Aug-2022
• Completion Date: 07-Aug-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-28:2010 - 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)

Relations

• Replaces: EN 60601-2-28:1993 - Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 60601-2-28:2019 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
• Effective Date: 01-Oct-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-28:2010
01-september-2010
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SIST EN 60601-2-28:1995
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ELVWYHQHODVWQRVWLUHQWJHQVNLKQDSUDY]D]GUDYQLãNHSUHJOHGH,(&

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)
Medizinische elektrische Geräte - Teil 2-28: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgenstrahlern für die
medizinische Diagnostik (IEC 60601-2-28:2010)
Appareils éléctromédicaux - Partie 2-28: Exigences particulières pour la sécurité de base
et les performances essentielles des gaines équipées pour diagnostic médical (CEI
60601-2-28:2010)
Ta slovenski standard je istoveten z: EN 60601-2-28:2010
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-28:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-28:2010

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SIST EN 60601-2-28:2010

EUROPEAN STANDARD
EN 60601-2-28

NORME EUROPÉENNE
May 2010
EUROPÄISCHE NORM

ICS 11.040.55 Supersedes EN 60601-2-28:1993


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 60601-2-28:2010)


Appareils éléctromédicaux -  Medizinische elektrische Geräte -
Partie 2-28: Exigences particulières Teil 2-28: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des gaines équipées pour diagnostic von Röntgenstrahlern für die medizinische
médical Diagnostik
(CEI 60601-2-28:2010) (IEC 60601-2-28:2010)




This European Standard was approved by CENELEC on 2010-04-01. 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 Central Secretariat 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 Central Secretariat 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels


© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-28:2010 E

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SIST EN 60601-2-28:2010
EN 60601-2-28:2010 - 2 -
Foreword
The text of document 62B/778/FDIS, future edition 2 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 was approved by CENELEC as EN 60601-2-28 on 2010-04-01.
This European Standard supersedes EN 60601-2-28:1993.
The second edition of this particular standard has been prepared to fit EN 60601-1:2006, which is
referred to as the general standard.
When the first edition was developed, mainly X-RAY TUBE ASSEMBLIES holding a glass insert were
considered and EN 60601-1:1990 was in place. While the variety of modern X-RAY TUBE ASSEMBLIES
and technologies has increased, the third edition of the general standard requires the MANUFACTURER
to perform RISK MANAGEMENT. The technical modifications versus the first edition of EN 60601-2-28
account for these changes.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2011-01-01
national standard or by endorsement
– latest date by which the nation
...