EN 60601-2-33:2010
(Main)Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33:2010 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker. This third edition cancels and replaces the second edition published in 2002, its Amendment 1 (2005) and Amendment 2 (2007) and constitutes a technical revision. This third edition of IEC 60601-2-33 is based on the second amendment to Edition 2. It has also been adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate.
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik
Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical
La CEI 60601-2-33:2010 établit des exigences particulières relatives à la sécurité de base et aux performances essentielles pour les appareils à résonance magnétique en matière de protection pour le patient et le personnel pour la résonance magnétique. Cette troisième édition annule et remplace la deuxième édition parue en 2002, son Amendement 1 (2005) et son Amendement 2 (2007), et constitue une révision technique. Cette troisième édition de la CEI 60601-2-33 est basée sur le deuxième amendement de l'Edition 2. Elle a également été adaptée à la troisième édition de la CEI 60601-1 (2005), des modifications techniques ayant été introduites le cas échéant.
Medicinska električna oprema - 2-33. del: Posebne zahteve za varnost opreme za magnetno resonanco za medicinsko diagnostiko (IEC 60601-2-33:2010)
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MR OPREME in MR SISTEMOV, v nadaljevanju ME OPREME. Ta standard ne zajema uporabo MR OPREME zunaj PREDVIDENE UPORABE. 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.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-33:2010)Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical (CEI 60601-2-33:2010)Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-33:2010SIST EN 60601-2-33:2010en01-december-2010SIST EN 60601-2-33:2010SLOVENSKI
STANDARDSIST EN 60601-2-33:2003/A2:2008SIST EN 60601-2-33:2003/A1:2007SIST EN 60601-2-33:20031DGRPHãþD
SIST EN 60601-2-33:2010
EUROPEAN STANDARD EN 60601-2-33 NORME EUROPÉENNE
EUROPÄISCHE NORM October 2010
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 60601-2-33:2010 E
ICS 11.040.55 Supersedes EN 60601-2-33:2002 + A1:2005 + A2:2008
English version
Medical electrical equipment -
Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)
Appareils électromédicaux -
Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical (CEI 60601-2-33:2010)
Medizinische elektrische Geräte -
Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-33:2010)
This European Standard was approved by CENELEC on 2010-10-01. 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.
SIST EN 60601-2-33:2010
EN 60601-2-33:2010 - 2 -
Foreword The text of document 62B/777/FDIS, future edition 3 of IEC 60601-2-33, 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 60601-2-33 on 2010-10-01. This European Standard supersedes EN 60601-2-33:2002 + A1:2005 + A2:2008. This EN 60601-2-33:2010 is based on the second amendment to EN 60601-2-33:2002. It has also been adapted to EN 60601-1:2006, with technical modifications being introduced where appropriate. 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
national standard or by endorsement
(dop)
2011-07-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2013-10-01 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 sub
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