EN 60601-2-6:2015
(Main)Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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.
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 Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-6 ®
Edition 2.0 2012-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX S
ICS 11.040.60 ISBN 978-2-88912-062-8
– 2 – 60601-2-6 © IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 7
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 8
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents. 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11
201.10 Protection against unwanted and excessive radiation HAZARDS . 11
201.11 Protection against excessive temperatures and other HAZARDS . 12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 12
201.13 HAZARDOUS SITUATIONS and fault conditions . 14
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14
201.15 Construction of ME EQUIPMENT . 14
201.16 ME SYSTEMS . 14
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 14
202 Electromagnetic compatibility – Requirements and tests . 14
Annexes . 15
ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 16
Annex AA (informative) Particular guidance and rationale . 17
Index of defined terms used in this particular standard. 20
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 8
Table 201.C.101 – Marking on the outside of MICROWAVE THERAPY EQUIPMENT or its
parts . 16
Table 201.C.102 – Marking on the inside of MICROWAVE THERAPY EQUIPMENT or its parts . 16
60601-2-6 © IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-6: Particular requirements for the basic safety and
essential performance of microwave therapy equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
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services carried out by independent certification bodies.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-6 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
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.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/985/FDIS 62D/1008/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
– 4 – 60601-2-6 © IEC:2012
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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.
...
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