EN 60601-2-3:2015
(Main)Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
IEC 60601-2-3:2012 specifies the requirements for the basic safety and essential performance of short-wave therapy equipment. Short-wave therapy equipment are defined as medical equipment for the therapeutic treatment of a patient by exposure to electric or magnetic fields produced in the frequency range of more than 13 MHz but not exceeding 45 MHz. Equipment having a rated output power not exceeding 10 W are exempted from certain requirements of this standard. This third edition cancels and replaces the second edition of IEC 60601-2-3 published in 1991 and its amendment 1 published in 1998. This edition constitutes a technical revision and has been aligned with IEC 60601-1:2005.
Medizinische elektrische Geräte - Teil 2-3: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Kurzwellen-Therapiegeräten
Appareils électromédicaux - Partie 2-3: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à ondes courtes
La CEI 60601-2-3:2012 spécifie les exigences particulières de sécurité de base et de performances essentielles applicables aux appareils de thérapie à ondes courtes. Les appareils de thérapie à ondes courtes sont définis comme les appareils électromédicaux de traitement thérapeutique d'un patient par exposition de celui-ci à des champs électriques ou magnétiques produits dans la plage de fréquences comprises entre 13 MHz et 45 MHz. Les appareils dont la puissance de sortie assignée ne dépasse pas 10 W sont exemptés de certaines exigences de la présente norme. Cette troisième édition annule et remplace la deuxième édition de la CEI 60601-2-3 publiée en 1991 et son amendement 1 publié en 1998. Cette édition constitue une révision technique et s'aligne avec la CEI 60601-1:2005.
Medicinska električna oprema - 2-3. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za opremo za kratkovalovno terapijo
Ta standard navaja zahteve za varnost OPREME ZA KRATKOVALOVNO TERAPIJO, v nadaljevanju ELEKTROMEDICINSKA OPREMA, kot je opredeljena v podtočki 201.3.206. Za OPREMO MANJŠIH MOČI, kot je opredeljena v podtočki 201.3.202, določene zahteve tega standarda ne veljajo.
General Information
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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 2-3: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Kurzwellen-TherapiegerätenAppareils électromédicaux - Partie 2-3: Règles particulières de sécurité de base et de performances essentielles des appareils de thérapie à ondes courtesMedical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment11.040.60Terapevtska opremaTherapy equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-3:2015SIST EN 60601-2-3:2015en01-september-2015SIST EN 60601-2-3:2015SLOVENSKI
STANDARDSIST EN 60601-2-3:1995/A1:2002SIST EN 60601-2-3:19951DGRPHãþD
SIST EN 60601-2-3:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 60601-2-3
May 2015 ICS 11.040.60
Supersedes
EN 60601-2-3:1993
English Version
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment (IEC 60601-2-3:2012)
Appareils électromédicaux - Partie 2-3: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à ondes courtes (IEC 60601-2-3:2012)
Medizinische elektrische Geräte - Teil 2-3: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Kurzwellen-Therapiegeräten (IEC 60601-2-3:2012) This European Standard was approved by CENELEC on 2015-04-14. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17,
B-1000 Brussels © 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-3:2015 E SIST EN 60601-2-3:2015
EN 60601-2-3:2015 (E) 2
Foreword The text of document 62D/977/FDIS, future edition 3 of IEC 60601-2-3, prepared by SC 62D, "Electromedical equipment", of IEC TC 62, "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-3:2015.
The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14
This document supersedes EN 60601-2-3:1993 + A1:1998. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this document.
Endorsement notice The text of the International Standard IEC 60601-2-3:2012 was approved by CENELEC as a European Standard without any modification. SIST EN 60601-2-3:2015
EN 60601-2-3:2015 (E)
3 Annex ZZ (informative)
Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Direct
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