EN 60601-2-6:2015

Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

IEC 60601-2-6:2012 specifies the minimum requirements considered to provide for a practical degree of safety in the operation of microwave therapy equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005 and amendment 1, 2012). This second edition cancels and replaces the first edition of IEC 60601-2-6, published in 1984. This edition constitutes a technical revision and has been aligned to the third edition of IEC 60601-1:2005+A1:2012.

Medizinische elektrische Geräte - Teil 2-6: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Mikrowellen-Therapiegeräten

Appareils électromédicaux - Partie 2-6: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à micro-ondes

La CEI 60601-2-6:2012 spécifie les exigences minimales considérées comme assurant un degré pratique de sécurité dans le fonctionnement des appareils de thérapie à micro-ondes. La présente norme particulière modifie et complète la CEI 60601-1 (troisième édition, 2005 et amendement 1, 2012). Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-6, publiée en 1984. Cette édition constitue une révision technique et s'aligne avec la troisième édition de la CEI 60601-1:2005+A1:2012.

Medicinska električna oprema - 2-6. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za mikrovalovno terapijo

Ta mednarodni standard navaja zahteve za varnost OPREME ZA MIKROVALOVNO TERAPIJO, ki se uporablja v zdravstvu, kot je opredeljena v podtočki 201.3.204.

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• 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 60601-2-6:2015 - Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

Relations

• Amended By: EN 60601-2-6:2015/A1:2016 - Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-6:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DPLNURYDORYQRWHUDSLMR
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and
essential performance of microwave therapy equipment
Medizinische elektrische Geräte - Teil 2-6: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Mikrowellen-Therapiegeräten
Appareils électromédicaux - Partie 2-6: Règles particulières de sécurité de base et de
performances essentielles des appareils de thérapie à micro-ondes
Ta slovenski standard je istoveten z: EN 60601-2-6:2015
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-6:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-6:2015

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SIST EN 60601-2-6:2015


EUROPEAN STANDARD EN 60601-2-6

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.60

English Version
Medical electrical equipment - Part 2-6: Particular requirements
for the basic safety and essential performance of microwave
therapy equipment
(IEC 60601-2-6:2012)
Appareils électromédicaux - Partie 2-6: Exigences Medizinische elektrische Geräte - Teil 2-6: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de thérapie à micro-ondes wesentlichen Leistungsmerkmale von Mikrowellen-
(IEC 60601-2-6:2012) Therapiegeräten
(IEC 60601-2-6:2012)
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 60601-2-6:2015 E

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SIST EN 60601-2-6:2015
EN 60601-2-6:2015 (E)

Foreword
The text of document 62D/985/FDIS, future edition 2 of IEC 60601-2-6, 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 60601-2-6:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-14
standards conflicting with the
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 [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 60601-2-6:2012 was approved by CENELEC as a European
Standard without any modification.
2

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SIST EN 60601-2-6:2015
EN 60601-2-6:2015 (E)

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 Ass
...