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

IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54.

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

La CEI 60601-2-54:2009 s'applique à la sécurité de base et aux performances essentielles des appareils electromédicaux et des systèmes electromédicaux destinés à la radiographie de projection et à la radioscopie. Les exigences de sécurité minimales spécifiées dans la présente norme particulière sont estimées assurer un degré de sécurité réalisable dans le cadre du fonctionnement des appareils EM utilisés pour la radiographie et la radioscopie. Des dispositions supplémentaires concernant les procédures d'intervention applicables aux appareils EM sont spécifiées dans la CEI 60601-2-43. La CEI 60601-2-54:2009 a été élaborée en vue d'une utilisation avec la troisième édition de la CEI 60601-1 (2005) et ses normes collatérales.

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

General Information

• Status: Published
• Publication Date: 17-Sep-2009
• Withdrawal Date: 31-Jul-2012
• ICS: 11.040.50 - Radiographic 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: 6060 - Document made available - Publishing
• Start Date: 18-Sep-2009
• Completion Date: 18-Sep-2009
• 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 - Medical electrical equipment - Part 2-54: Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009)

Relations

• Replaces: EN 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-2-7:1998 - Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
• Effective Date: 28-Jan-2023
• 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
• Amended By: EN 60601-2-54:2009/A1:2015 - 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: 28-Jan-2023
• Amended By: 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
• Effective Date: 07-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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)Appareils électromédicaux - Partie 2-54: Exigences particulières relatives à la sécurité de base et aux performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie (CEI 60601-2-54:2009)Medical electrical equipment - Part 2-54: Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009)11.040.50Radiografska opremaRadiographic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-54:2009SIST EN 60601-2-54:2009en,fr01-november-2009SIST EN 60601-2-54:2009SLOVENSKI
STANDARD



SIST EN 60601-2-54:2009



EUROPEAN STANDARD EN 60601-2-54 NORME EUROPÉENNE
EUROPÄISCHE NORM September 2009
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: Avenue Marnix 17, B - 1000 Brussels
© 2009 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-54:2009 E
ICS 11.040.50 Supersedes EN 60601-2-7:1998, EN 60601-2-28:1993 (partially) and EN 60601-2-32:1994
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)
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 (CEI 60601-2-54:2009)
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)
This European Standard was approved by CENELEC on 2009-08-01. 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, 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.
SIST EN 60601-2-54:2009



EN 60601-2-54:2009 - 2 -
Foreword The text of document 62B/735/FDIS, future edition 1 of IEC 60601-2-54, 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 60601-2-54 on 2009-08-01. EN 60601-2-54 was developed for use with EN 60601-1:2006.
This European Standard supersedes EN 60601-2-7:1998, EN 60601-2-32:1994 and EN 60601-2-28:1993 (partially). The following dates were fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop)
2010-05-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2012-08-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. In this standard, the following print types are used: – Requirements and definitions: roman type. – Test specifications: italic type. – Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses w
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