SIST EN 60601-2-3:2015

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 Directives can be applied to the products falling within the scope of this standard.
SIST EN 60601-2-3:2015



SIST EN 60601-2-3:2015



IEC 60601-2-3Edition 3.0 2012-04INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment –
Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
Appareils électromédicaux –
Partie 2-3: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à ondes courtes
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE SICS 11.040.60 PRICE CODECODE PRIXISBN 978-2-8322-0071-1
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale ®
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé. SIST EN 60601-2-3:2015



– 2 – 60601-2-3 © 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 . 8 201.7 ME EQUIPMENT identification, marking and documents. 8 201.8
Protection against electrical HAZARDS from ME EQUIPMENT . 10 201.9
Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10
Protection against unwanted and excessive radiation HAZARDS . 14 201.11
Protection against excessive temperatures and other HAZARDS . 14 201.12
Accuracy of controls and instruments and protection against hazardous outputs . 14 201.13
HAZARDOUS SITUATIONS and fault conditions. 15 201.14
PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16 201.15
Construction of ME EQUIPMENT . 16 201.16
ME SYSTEMS . 16 201.17
Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16 Annexes . 16 ANNEX C (informative)
Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS . 17 Annex AA (informative)
Particular guidance and rationale . 18 Index of defined terms used in this particular standard. 20
Figure 201.101 – Dielectric strength test for capacitive APPLICATORS . 12 Figure 201.102 – Test probe . 13 Figure 201.103 – Dielectric strength test for inductive APPLICATORS . 14
SIST EN 60601-2-3:2015



60601-2-3 © IEC:2012 – 3 – INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-3: Particular requirements for the basic safety and essential
performance of short-wave 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, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by 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. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
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 60601-2-3 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. 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. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/977/FDIS 62D/993/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. SIST EN 60601-2-3:2015



– 4 – 60601-2-3 © 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. 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 within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: – “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; – “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; – “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be
• reconfirmed, • withdrawn, • replaced by a revised edition, or • amended.
SIST EN 60601-2-3:2015



60601-2-3 © IEC:2012 – 5 – INTRODUCTION The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of short-wave therapy equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment – Part 1: General requirements for safety and essential performance, hereinafter referred to as the general standard (see 201.1.4). The requirements are followed by specifications for the relevant tests. A "particular guidance and rationale" section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex AA. Clauses or subclauses for which there are explanatory notes in annex AA are marked with an asterisk (*). It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this standard. SIST EN 60601-2-3:2015



– 6 – 60601-2-3 © IEC:2012 MEDICAL ELECTRICAL EQUIPMENT –
Part 2-3: Particular requirements for the basic safety and essential
performance of short-wave therapy equipment
201.1 Scope, object and related standards Clause 1 of the general standard1 applies, except as follows: 201.1.1 Scope Replacement: This particular standard specifies the requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, as defined in subclause 201.3.206. LOW POWER EQUIPMENT as defined in subclause 201.3.202 is exempted from certain requirements of this standard.
201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SHORT-WAVE THERAPY EQUIPMENT as defined in 201.3.206. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. ————————— 1 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance SIST EN 60601-2-3:2015



60601-2-3 © IEC:2012 – 7 – The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a collateral standard are numbered
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