EN 60601-2-54:2009/A2:2019

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

2019-04-04-JO-: link to legislation and mandate M/295 removed following CLC/BT decision D162/C076
2018-10-31: Lack of compliance from the HAS consultant
2018-08-23 : Consultant's assessment is missing.
in-check - 2018-07-12 - Consultant's assessment is rejected at CDV stage.

Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie und Radioskopie

Appareils électromédicaux - Partie 2-54: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie

Medicinska električna oprema - 2-54. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za radiografijo in radioskopijo - Dopolnilo A2 (IEC 60601-2-54:2009/A2:2018)

General Information

• Status: Published
• Publication Date: 23-May-2019
• Withdrawal Date: 23-May-2022
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-May-2019
• Completion Date: 24-May-2019
• 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 60601-2-54:2009/A2:2019 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009/A2:2018)

Relations

• Amends: EN 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-54:2009/A2:2019
01-julij-2019
Medicinska električna oprema - 2-54. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za radiografijo in radioskopijo - Dopolnilo
A2 (IEC 60601-2-54:2009/A2:2018)
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and
essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-
54:2009/A2:2018)
Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie
und Radioskopie (IEC 60601-2-54:2009/A2:2018)
Appareils électromédicaux - Partie 2-54: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement X utilisés pour la
radiographie et la radioscopie (IEC 60601-2-54:2009/A2:2018)
Ta slovenski standard je istoveten z: EN 60601-2-54:2009/A2:2019
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-54:2009/A2:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-54:2009/A2:2019

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SIST EN 60601-2-54:2009/A2:2019


EUROPEAN STANDARD EN 60601-2-54:2009/A2

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2019
ICS 11.040.50

English Version
Medical electrical equipment - Part 2-54: Particular requirements
for the basic safety and essential performance of X-ray
equipment for radiography and radioscopy
(IEC 60601-2-54:2009/A2:2018)
Appareils électromédicaux - Partie 2-54: Exigences Medizinische elektrische Geräte - Teil 2-54: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit und die wesentlichen
essentielles des appareils à rayonnement X utilisés pour la Leistungsmerkmale von Röntgeneinrichtungen für
radiographie et la radioscopie Radiographie und Radioskopie
(IEC 60601-2-54:2009/A2:2018) (IEC 60601-2-54:2009/A2:2018)
This amendment A2 modifies the European Standard EN 60601-2-54:2009; it was approved by CENELEC on 2018-08-03. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, 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 60601-2-54:2009/A2:2019 E

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SIST EN 60601-2-54:2009/A2:2019
EN 60601-2-54:2009/A2:2019 (E)
European foreword
The text of document 62B/1089/FDIS, future IEC 60601-2-54/A2, 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 60601-2-54:2009/A2:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2019-11-24
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-05-24
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 60601-2-54:2009/A2:2018 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 62220-1-3:2008 NOTE Harmonized as EN
...