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
Current Stage
6060 - Document made available
Due Date
22-May-2015
Completion Date
22-May-2015

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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.

---------------------- Page: 1 ----------------------
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.
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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 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.
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SIST EN 60601-2-6:2015
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SIST EN 60601-2-6:2015
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

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.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN 60601-2-6:2015
– 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

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SIST EN 60601-2-6:2015
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,

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 60601-2-6 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.
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SIST EN 60601-2-6:2015
– 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.
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
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SIST EN 60601-2-6:2015
60601-2-6 © 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 microwave therapy equipment.

This particular standard amends and supplements IEC 60601-1 (third edition, 2005 and

amendment 1,2012): 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 neces-

sitated 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.
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SIST EN 60601-2-6:2015
– 6 – 60601-2-6 © IEC:2012
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-6: Particular requirements for the basic safety and
essential performance of microwave therapy equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:

This International Standard specifies requirements for the safety of MICROWAVE THERAPY

EQUIPMENT used in medical practice, as defined in 201.3.204.
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for MICROWAVE THERAPY EQUIPMENT as defined in 201.3.204.

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 60601-1-2 applies as modified in Clause 202. 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.

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”

___________

The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance
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SIST EN 60601-2-6:2015
60601-2-6 © IEC:2012 – 7 –

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 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term “this standard” is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies.
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-
1:2005+A1:2012 , apply, except as follows:
Addition:
201.3.201
APPLICATOR
microwave radiator for local application of microwave energy to the PATIENT

Note 1 to entry: Some examples are dipoles, dipoles with reflectors, modified dipoles, dipole arrays, open

waveguides, and dielectric radiators.
___________
A1:2012 To be published
---------------------- Page: 13 ----------------------
SIST EN 60601-2-6:2015
– 8 – 60601-2-6 © IEC:2012
201.3.202
* CONTACT APPLICATOR
APPLICATOR that contacts the PATIENT and is thus an APPLIED PART
201.3.203
MATCHED LOAD

complex load which, when connected, results in the maximum power being delivered from the

MICROWAVE THERAPY EQUIPMENT into the load
201.3.204
MICROWAVE THERAPY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT for the treatment of the PATIENT by means of a propagated

electromagnetic field in the frequency range of more than 300 MHz but not exceeding 30 GHz

201.3.205
* NON-CONTACT APPLICATOR
an APPLICATOR that does not contact or touch the PATIENT
201.3.206
PHANTOM

device which receives the radiated microwave energy and is intended to simulate the PATIENT

for test purposes
201.3.207
* RATED OUTPUT POWER
value of the maximum high-frequency power which can be fed into a MATCHED LOAD
201.3.208
* UNWANTED RADIATION
PATIENT for treatment purposes
microwave radiation which is not incident on or in the
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements

Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in

Table 201.101.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause

Free from the display of incorrect numerical values associated with the therapy to be performed. 201.12.1

201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
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SIST EN 60601-2-6:2015
60601-2-6 © IEC:2012 – 9 –
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
201.7.2.101 Output
MICROWAVE THERAPY EQUIPMENT shall be marked with the following information:
• RATED OUTPUT POWER in watts;
• MATCHED LOAD in ohms;
• operating frequency in megahertz or gigahertz;
• symbol number 5140 (non-ionizing electromagnetic radiation) of IEC 60878.
Compliance is checked by inspection.
201.7.3 * Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclauses:
201.7.3.101

Symbol number 5140 (non-ionizing electromagnetic radiation) of IEC 60878 shall be applied

to any internal ACCESS COVER if the removal of that cover might cause the ME EQUIPMENT to fail

the requirement of 201.10.3.102.

Compliance is checked by the test of 201.10.3.102 with any internal ACCESS COVER removed if

it is not marked with the above symbol and also with any external ACCESS COVER not bearing

this symbol removed.
201.7.3.102

Symbols number 2 (general warning sign) and number 10 (follow operating instructions) of

Table D.2 in Annex D of the general standard shall be displayed on or near components or on

panels giving access to components if adjustment or replacement of these components might

cause the ME EQUIPMENT to fail to comply with IEC 60601-1-2 and Clause 202.
Compliance is checked by inspection.
201.7.4.2 * Control devices
Addition:

The output control shall have a scale and/or associated indicator representing the microwave

energy output. The numeral "0" shall not be used unless any microwave energy delivered in

this position is less than 10 mW. If the output scale or indicator represents watts of output

power, it shall be so marked.
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SIST EN 60601-2-6:2015
– 10 – 60601-2-6 © IEC:2012
Compliance is checked by inspection.
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101 Additional instructions for use

The instructions for use shall include the following information where applicable:

a) A warning that MICROWAVE THERAPY EQUIPMENT should not be used in the presence of

flammable anesthetics.

b) A description of the expected effect on the target tissue (e.g. diffuse gentle heating,

localized gentle heating, localized intense heating for the purpose of tissue destruction,

etc.)

c) A description of the area of intended tissue effect with relation to the APPLICATOR.

d) The correct procedures for positioning the APPLICATOR for a particular treatment while

minimizing the irradiation of other parts of the body.

e) Advice that the output power should be switched off when the APPLICATOR is being

positioned for treatment.

f) Advice on the potential HAZARDS of having conductive objects or materials near to the

PATIENT:

– Microwave energy should not be applied to persons wearing metallic jewellery or

clothing containing metallic material (for example metallic buttons, clips or thread).

– Parts of the body of the PATIENT containing metallic implants (for example a medullary

nail) should not be treated unless specialized medical advice is obtained.
– Hearing aids should be removed.

– PATIENTS with implanted electronic devices and/or electrodes should be excluded from

treatment with microwaves and from areas where the ME EQUIPMENT is operated.

g) A warning to be careful when handling APPLICATORS, since rough handling may change the

directional characteristics of the APPLICATOR.

h) Information on the type and size of APPLICATOR recommended for treating various parts of

the body and the maximum power allowable for a particular APPLICATOR.
i) During use of NON-CONTACT APPLICATORS:

– advice that PATIENTS with reduced thermal sensitivity in the proposed area of treatment

should normally not be treated with NON-CONTACT APPLICATORS of microwave therapy;

– advice that PATIENTS who are unable to provide real time feedback regarding the

treatment should normally not be treated with NON-CONTACT APPLICATORS of microwave

therapy;

– advice that a NON-CONTACT APPLICATOR should not be directed towards the eyes or

testes;

– advice that the PATIENT should be provided with microwave protection goggles, where

appropriate;

– a warning statement that persons not receiving treatment should remain more than 1,5

meters from a NON-CONTACT APPLICATOR during the production of microwave energy;
– a description of the potential dangers to OPERATORS.
201.7.9.3 Technical description
201.7.9.3.1 General
Addition to the first paragraph:
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SIST EN 60601-2-6:2015
60601-2-6 © IEC:2012 – 11 –

– instructions on how to test the output power of the MICROWAVE THERAPY EQUIPMENT;

– where the MICROWAVE THERAPY EQUIPMENT has an output power control:

• a diagram showing the power output versus the output control setting at the MATCHED

LOAD;

– information on the precautions to be observed when the warning symbols mentioned in

201.7.3.101 and/or 201.7.3.102 a
...

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