IEC 60601-2-6:2012
(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.
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.
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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
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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
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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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.
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
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.
– 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
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
– 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.
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.
– 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:
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 are displayed.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.7.1 * General requirements
Addition to item b):
– with the microwave output not energized but in such a way that the LEAKAGE CURRENTS and
PATIENT AUXILIARY CURRENTS are not affected.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:
201.10.1 X-radiation
This subclause clause of the general standard is not applicable
201.10.2 Alpha, beta, gamma, neutron radiation and other particle radiation
This clause of the general standard is not applicable.
201.10.3 Microwave radiation
Addition:
NWANTED RADIATION
201.10.3.101 * U
UNWANTED RADIATION shall not exceed 10 mW/cm at a distance of 1 m from the front of a
NON-CONTACT APPLICATOR and 0,25 m from the rear of a NON-CONTACT APPLICATOR when tested
as described below.
Compliance is checked by the following test:
Adjust the output to the maximum output power specified for each NON-CONTACT APPLICATOR.
UNWANTED RADIATION after placing the NON-CONTACT
Measure the power density of the
APPLICATOR at the maximum distance the MANUFACTURER recommends from a suitable
PHANTOM. If a suitable PHANTOM is not specified by the MANUFACTURER, the phantom shall
consist of a cylindrical container 0,20 m diameter x 0,50 m long made of low-loss material, for
example acrylic, filled with a solution of 9 g NaCI per litre of water.
– 12 – 60601-2-6 © IEC:2012
201.10.3.102 * Leakage of microwave radiation
The leakage of microwave radiation from the ME EQUIPMENT ENCLOSURE, cables or
waveguides, and cable/waveguide connectors shall not exceed 10 mW/cm when measured
as described below.
Compliance is checked by the following test:
Connect the MICROWAVE THERAPY EQUIPMENT to a matched load and operate it at the rated
output power. Using a calibrated field probe, measure the microwave power density at
various points along the external surfaces of the EQUIPMENT, connectors, and
cables/waveguides.
NOTE Annex AA contains a guide to assist the reader in making repeatable measurements.
201.10.3.103 Limitation of microwave power
The RATED OUTPUT POWER of MICROWAVE THERAPY EQUIPMENT having a single output channel or
multiple output channels that can only be operated one channel at a time shall not exceed
250 W. The rated output power of microwave therapy equipment having multiple output
channels which can be operated simultaneously shall not exceed 125 W per channel.
Compliance is checked by inspection of the markings specified in 201.7.2.101.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT
Addition:
CONTACT APPLICATORS are APPLIED PARTS intended to supply heat to a PATIENT as part of the
intended clinical effect. Disclosure of temperatures is not required.
201.11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable anesthetics
Replacement:
MICROWAVE THERAPY EQUIPMENT shall not be CATEGORY AP or CATEGORY APG ME EQUIPMENT and
thus shall not be used in the presence of flammable anesthetics.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
Any incorporated indication of the output power may be in absolute units or in relative units.
60601-2-6 © IEC:2012 – 13 –
For an absolute indication, the measured output power shall not deviate from the indicated
value by more than ± 20 % of the indicated value.
Compliance is checked by measurement of the output power as follows:
Replace the APPLICATOR with a MATCHED LOAD and measure the maximum output power.
201.12.4 Protection against hazardous output
201.12.4.2 Indication of parameters relevant to safety
Addition:
201.12.4.2.101 * Output indicator
MICROWAVE THERAPY EQUIPMENT shall emit an audible signal when microwave energy is being
produced. The sound level produced shall be at least 30 dBA for NON-CONTACT APPLICATORS
and at least 40 dBA for all other APPLICATORS at a distance of 1 m from the front of the ME
EQUIPMENT.
Compliance is checked by functional check and measurement of the sound level.
Additional subclauses:
201.12.4.101 * Output reduction means
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall provide means to
reduce the power output to 5 % or less of the maximum output power for each range/mode or
to 10 W, whichever is the least.
Compliance is checked by measurement of the output power according to 201.12.1.
201.12.4.102 * Energizing the output
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall be so designed
that the output cannot be energized unless the output control is first set to the minimum
position.
This requirement shall also be met after the interruption and restoration of the mains supply.
Compliance is checked by inspection and functional test.
201.12.4.103 * Adjustable timer
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall be provided with
an adjustable timer which de-energizes the output after a preselected operating period has
elapsed. The timer shall have a range not exceeding 30 min and an accuracy of
± 1 min.
Compliance is checked by inspection, functional test and measurement of the operating time.
201.12.4.104 De-energizing the output
MICROWAVE THERAPY EQUIPMENT shall have a means to manually de-energize the microwave
output at any time regardless of the status of any automatic control means or timer.
Compliance is checked by functional inspection.
– 14 – 60601-2-6 © IEC:2012
201.12.4.105 Maximum power output
When measured immediately after any warming up period specified in the instructions for use,
the maximum output power shall not be greater than the RATED OUTPUT POWER plus 20 %.
Compliance is checked by replacing the APPLICATOR with a MATCHED LOAD, setting any output
controls to maximum and measuring the output power.
201.13 HAZARDOUS SITUATIONS and fault conditions
Clause 13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies, except as follows:
201.15.4 ME EQUIPMENT components and general assembly
Additional subclause:
201.15.4.101 * ENCLOSURES and covers
Any ACCESS COVER or ENCLOSURE, the removal of which can result in the ME EQUIPMENT failing
to comply with the requirement of 201.10.3.102, shall be removable only with the aid of a
TOOL.
Compliance is checked by inspection.
201.16 ME SYSTEMS
Clause 16 of the general standard applies.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the general standard applies:
202 Electromagnetic compatibility – Requirements and tests
IEC 60601-1-2:2007 applies except as follows:
202.4 General requirements
Additional subclause:
202.4.101 General test setup
Compliance testing of MICROWAVE THERAPY EQUIPMENT shall occur while radiating into a
suitable PHANTOM as specified by the MANUFACTURER or with the APPLICATOR replaced by a
MATCHED LOAD.
60601-2-6 © IEC:2012 – 15 –
Annexes
The annexes of the general standard apply except as follows:
– 16 – 60601-2-6 © IEC:2012
Annex C
(informative)
Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts
Additional requirements for marking on the outside of MICROWAVE THERAPY EQUIPMENT are
found in Table 201.C.101.
Table 201.C.101 – Marking on the outside of
MICROWAVE THERAPY EQUIPMENT or its parts
Description of marking Subclause
RATED OUTPUT POWER 201.7.2.101
MATCHED LOAD 201.7.2.101
Operating frequency 201.7.2.101
Non-ionizing radiation symbol 201.7.2.101
201.C.2 Marking on the inside of ME EQUIPMENT, ME SYSTEMS or their parts
Additional requirements for marking on the inside of MICROWAVE THERAPY EQUIPMENT are found
in Table 201.C.102.
Table 201.C.102 – Marking on the inside of
MICROWAVE THERAPY EQUIPMENT or its parts
Description of marking Subclause
Non-ionizing radiation symbol 201.7.3.101
Symbols No. 2 and 10 of Table D.2 in Annex D of the general standard. 201.7.3.102
60601-2-6 © IEC:2012 – 17 –
Annex AA
(informative)
Particular guidance and rationale
AA.1 General guidance
This annex provides a concise rationale for the important requirements of the standard and is
intended for those who are familiar with the subject of the standard but who have not
participated in its development. An understanding of the reasons for the main requirements is
considered to be essential for the proper application of the standard. Furthermore as clinical
practice and technology change it is believed that a rationale for the present requirements will
facilitate any revision of the standard necessitated by these developments.
AA.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclause in this particular standard, with
clause and subclause numbers parallel to those in the body of the document.
Subclause 201.1.1 – Scope
The scope was expanded to include additional uses of microwave energy in medical
equipment developed since the first edition. This standard was originally written to cover
microwave devices that were used to gently heat tissue as a means to improve circulation.
New uses for microwave energy include devices that are used to intentionally heat tissue to
temperatures that cause cell death.
Definition 201.3.202 – CONTACT APPLICATOR
These are APPLICATORS that must intentionally touch or be introduced into the patient in order
to be used. The intent of a CONTACT APPLICATOR is to use microwave radiation to heat a
specific area of tissue to a temperature sufficient to cause tissue death. The clinical reason
for this treatment may include (but is not limited to) shrinkage of tissue or treatment of
diseased tissue. Depending on the type of treatment, the patient may or may not be
anesthetized. This definition was created to clearly differentiate it from NON-CONTACT
APPLICATORS.
Definition 201.3.205 – NON-CONTACT APPLICATOR
These are APPLICATORS that are not intended to touch the PATIENT during use. These
APPLICATORS are used to gently heat PATIENT tissue. In general, the PATIENT is awake during
this treatment and able to comment if the heating causes discomfort or pain.
Definition 201.3.207 – RATED OUTPUT POWER
Selection of the power measurement equipment and technique will depend on whether the
output is continuous or pulsed.
UNWANTED RADIATION
Definition 201.3.208 –
Microwave energy other than that responsible for creating the desired clinical effect. This
definition allows the creation of requirements and tests to measure this energy so as to
protect tissue that is not in the treatment area. This includes PATIENT tissue as well as that of
the OPERATOR.
– 18 – 60601-2-6 © IEC:2012
Subclause 201.4.3.101 – Additional ESSENTIAL PERFORMANCE requirements
If a device does display numerical values representing the output power, then the correct
display of such values is considered ESSENTIAL PERFORMANCE.
Subclause 201.7.3 – Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
The aim of the marking is to protect SERVICE PERSONNEL from UNWANTED RADIATION and notify
them that ELECTROMAGNETIC DISTURBANCE suppression may be degraded during maintenance
or repair.
Subclause 201.7.4.2 – Control devices
As the power delivered to the load depends on the load resistance, a graduation in relative
units is considered to be adequate. If the numeral "0" is displayed, the OPERATOR will expect
zero output at this position of the control.
Subclause 201.8.7.1 – General requirements
As small LEAKAGE CURRENTS at mains frequency cannot easily be measured in the presence of
high frequency power, the high-frequency generator is disabled during the tests.
Subclause 201.10.3.101 – UNWANTED RADIATION
This requirement limits UNWANTED RADIATION and creates a "safety zone" around a NON-
CONTACT APPLICATOR. In NORMAL USE, the OPERATOR is not continuously exposed to microwave
radiation. During positioning of the PATIENT, and the NON-CONTACT APPLICATOR, the output is
supposed to be switched off, and the instructions for use warn the OPERATOR to be more than
1.5 meters from a NON-CONTACT APPLICATOR during treatment.
Subclause 201.10.3.102 – Leakage of microwave radiation
This requirement limits UNWANTED RADIATION associated with the ENCLOSURE, cables,
waveguides, and cable/waveguide connectors.
To make the measurements repeatable, the following is suggested.
• Determine the fundamental and harmonic content of the RF energy present in the ME
EQUIPMENT to be measured.
• Select a meter/sensor appropriate for the measurement given the sensor/meter
requirements listed below.
• Set the meter to display mW/cm and set the display to a mode which displays the current
field reading (no averaging).
• Slowly sweep the probe continuously to cover the surfaces being tested keeping the
electrical center of the sensor within 38 mm of the surface being investigated. Note the
location(s) of readings greater than or equal to 5 mW/cm .
• Clear data in meter, set for max hold and investigate the locations recorded above one at
a time. Rotate the surface of the probe so that all axis of the probe are exposed to the
location under test. Record the maximum reading and repeat for each location.
• Verify that all maximum readings are less than or equal to the limit.
It is recommended that the RF sensor used be an electric field sensor with the following or
better specifications:
• Maximum sensor size: 70 mm in diameter
• Sensor and meter frequency response includes the lowest frequency to be measured up to
the highest harmonic present, ± 1 dB (Note: Calibrations can be performed at all the
frequencies of interest, if the probe is not specified to cover the full frequency range
60601-2-6 © IEC:2012 – 19 –
needed, provided that the response of the probe is not down by more than 6 dB from
frequencies within its specified range.)
• Sensor and meter isotropic response better than ± 2 dB at a frequency within the sensors
calibrated range.
• Maximum spacing between sensor and ME EQUIPMENT: 38 mm from the center of the
diameter of the sensor to the surface of the ME EQUIPMENT.
Subclause 201.11.4 – ME EQUIPMENT and ME SYSTEMS intended for use with flammable
anesthetics
Microwave energy can cause flammable gases to quickly heat to the flash point so MICROWAVE
THERAPY EQUIPMENT should never be used with flammable anesthetics.
Subclause 201.12.4.2.101 – Output indicator
The unexpected delivery of microwave energy is a HAZARD for the OPERATOR.
Subclause 201.12.4.101 – Output reduction means
MICROWAVE THERAPY EQUIPMENT utilizing NON-CONTACT APPLICATORS should have the ability to
treat PATIENTS with low power.
Subclause 201.12.4.102 – Energizing the output
This requirement prevents a PATIENT from being treated inadvertently at an excessive power
level.
...
IEC 60601-2-6 ®
Edition 2.2 2022-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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IEC 60601-2-6 ®
Edition 2.2 2022-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-5710-4
IEC 60601-2-6 ®
Edition 2.2 2022-09
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 2 . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 9
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 12
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 14
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 15
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT . 15
201.16 ME SYSTEMS . 15
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16
202 Electromagnetic compatibility disturbances – requirements and tests . 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. 21
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 10
Table 201.C.101 – Marking on the outside of MICROWAVE THERAPY EQUIPMENT or its
parts . 17
Table 201.C.102 – Marking on the inside of MICROWAVE THERAPY EQUIPMENT or its parts . 17
+AMD2:2022 CSV © IEC 2022
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
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patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-2-6 edition 2.2 contains the second edition (2012-04) [documents
62D/985/FDIS and 62D/1008/RVD], its amendment 1 (2016-04) [documents
62D/1331/FDIS and 62D/1351/RVD] and its amendment 2 (2022-09) [documents
62D/1847/CDV and 62D/1960/RVC].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
International standard IEC 60601-2-6 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
– 4 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
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
with IEC 60601-1:2005+A1:2012.
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.
+AMD2:2022 CSV © IEC 2022
The committee has decided that the contents of the base publication and its amendments 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.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
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.
INTRODUCTION to Amendment 2
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and
the amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised may be found within
the IEC document 62D/1792/DC. The results and comments on the DC may be found within
62D/1808/INF. The review report for this amendment is 62D/1830/RR.
+AMD2:2022 CSV © IEC 2022
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 and IEC 60601-1-12 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
___________
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
– 8 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
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 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, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC TR 60878:2015, Graphical symbols for electrical equipment in medical practice
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601‑1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, apply, except as follows:
___________
A1:2012 To be published
+AMD2:2022 CSV © IEC 2022
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.
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
microwave radiation which is not incident on or in the PATIENT for treatment purposes
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.
– 10 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
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.
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.
+AMD2:2022 CSV © IEC 2022
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.
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.)
APPLICATOR.
c) A description of the area of intended tissue effect with relation to the
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
NON-CONTACT APPLICATORS of microwave therapy;
should normally not be treated with
– 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;
– 12 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
– 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
NON-CONTACT APPLICATOR during the production of microwave energy;
meters from a
– 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:
– instructions on how to test the output power of the MICROWAVE THERAPY EQUIPMENT;
MICROWAVE THERAPY EQUIPMENT has an output power control:
– where the
• 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 are displayed.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.7.1 * General requirements
Addition to item b):
– with the microwave output not energized but in such a way that the LEAKAGE CURRENTS and
PATIENT AUXILIARY CURRENTS are not affected.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:
201.10.1 X-radiation
This subclause clause of the general standard is not applicable
201.10.2 Alpha, beta, gamma, neutron radiation and other particle radiation
This clause of the general standard is not applicable.
201.10.3 Microwave radiation
Addition:
201.10.3.101 * UNWANTED RADIATION
+AMD2:2022 CSV © IEC 2022
UNWANTED RADIATION shall not exceed 10 mW/cm at a distance of 1 m from the front of a
NON-CONTACT APPLICATOR and 0,25 m from the rear of a NON-CONTACT APPLICATOR when tested
as described below.
Compliance is checked by the following test:
Adjust the output to the maximum output power specified for each NON-CONTACT APPLICATOR.
UNWANTED RADIATION after placing the NON-CONTACT
Measure the power density of the
APPLICATOR at the maximum distance the MANUFACTURER recommends from a suitable
PHANTOM. If a suitable PHANTOM is not specified by the MANUFACTURER, the phantom shall
consist of a cylindrical container 0,20 m diameter x 0,50 m long made of low-loss material, for
example acrylic, filled with a solution of 9 g NaCI per litre of water.
201.10.3.102 * Leakage of microwave radiation
The leakage of microwave radiation from the ME EQUIPMENT ENCLOSURE, cables or
waveguides, and cable/waveguide connectors shall not exceed 10 mW/cm when measured
as described below.
Compliance is checked by the following test:
Connect the MICROWAVE THERAPY EQUIPMENT to a matched load and operate it at the rated
output power. Using a calibrated field probe, measure the microwave power density at
EQUIPMENT, connectors, and
various points along the external surfaces of the
cables/waveguides.
NOTE Annex AA contains a guide to assist the reader in making repeatable measurements.
201.10.3.103 Limitation of microwave power
The RATED OUTPUT POWER of MICROWAVE THERAPY EQUIPMENT having a single output channel or
multiple output channels that can only be operated one channel at a time shall not exceed
250 W. The rated output power of microwave therapy equipment having multiple output
channels which can be operated simultaneously shall not exceed 125 W per channel.
Compliance is checked by inspection of the markings specified in 201.7.2.101.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT
Addition:
CONTACT APPLICATORS are APPLIED PARTS intended to supply heat to a PATIENT as part of the
intended clinical effect. Disclosure of temperatures is not required.
201.11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable anesthetics
Replacement:
MICROWAVE THERAPY EQUIPMENT shall not be CATEGORY AP or CATEGORY APG ME EQUIPMENT and
thus shall not be used in the presence of flammable anesthetics.
– 14 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
Any incorporated indication of the output power may be in absolute units or in relative units.
For an absolute indication, the measured output power shall not deviate from the indicated
value by more than ± 20 % of the indicated value.
Compliance is checked by measurement of the output power as follows:
Replace the APPLICATOR with a MATCHED LOAD and measure the maximum output power.
201.12.4 Protection against hazardous output
201.12.4.2 Indication of parameters relevant to safety
Addition:
201.12.4.2.101 * Output indicator
MICROWAVE THERAPY EQUIPMENT shall emit an audible signal when microwave energy is being
produced. The sound level produced shall be at least 30 dBA for NON-CONTACT APPLICATORS
and at least 40 dBA for all other APPLICATORS at a distance of 1 m from the front of the ME
EQUIPMENT.
Compliance is checked by functional check and measurement of the sound level.
Additional subclauses:
201.12.4.101 * Output reduction means
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall provide means to
reduce the power output to 5 % or less of the maximum output power for each range/mode or
to 10 W, whichever is the least.
Compliance is checked by measurement of the output power according to 201.12.1.
201.12.4.102 * Energizing the output
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall be so designed
that the output cannot be energized unless the output control is first set to the minimum
position.
This requirement shall also be met after the interruption and restoration of the mains supply.
Compliance is checked by inspection and functional test.
+AMD2:2022 CSV © IEC 2022
201.12.4.103 * Adjustable timer
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall be provided with
an adjustable timer which de-energizes the output after a preselected operating period has
elapsed. The timer shall have a range not exceeding 30 min and an accuracy of
± 1 min.
Compliance is checked by inspection, functional test and measurement of the operating time.
201.12.4.104 De-energizing the output
MICROWAVE THERAPY EQUIPMENT shall have a means to manually de-energize the microwave
output at any time regardless of the status of any automatic control means or timer.
Compliance is checked by functional inspection.
201.12.4.105 Maximum power output
When measured immediately after any warming up period specified in the instructions for use,
the maximum output power shall not be greater than the RATED OUTPUT POWER plus 20 %.
Compliance is checked by replacing the APPLICATOR with a MATCHED LOAD, setting any output
controls to maximum and measuring the output power.
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
Clause 13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies, except as follows:
201.15.4 ME EQUIPMENT components and general assembly
Additional subclause:
201.15.4.101 * ENCLOSURES and covers
Any ACCESS COVER or ENCLOSURE, the removal of which can result in the ME EQUIPMENT failing
to comply with the requirement of 201.10.3.102, shall be removable only with the aid of a
TOOL.
Compliance is checked by inspection.
201.16 ME SYSTEMS
Clause 16 of the general standard applies.
– 16 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the general standard applies:
202 Electromagnetic compatibility disturbances – requirements and tests
IEC 60601-1-2:2007 applies except as follows:
202.4 General requirements
202.4.3 General test conditions
Additional subclause:
202.4.3.101 General test setup
Compliance testing of MICROWAVE THERAPY EQUIPMENT shall occur while radiating into a
suitable PHANTOM as specified by the MANUFACTURER or with the APPLICATOR replaced by a
MATCHED LOAD.
Annexes
The annexes of the general standard apply except as follows:
+AMD2:2022 CSV © IEC 2022
Annex C
(informative)
Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts
Additional requirements for marking on the outside of MICROWAVE THERAPY EQUIPMENT are
found in Table 201.C.101.
Table 201.C.101 – Marking on the outside of
MICROWAVE THERAPY EQUIPMENT or its parts
Description of marking Subclause
RATED OUTPUT POWER 201.7.2.101
MATCHED LOAD 201.7.2.101
Operating frequency 201.7.2.101
Non-ionizing radiation symbol 201.7.2.101
201.C.2 Marking on the inside of ME EQUIPMENT, ME SYSTEMS or their parts
Additional requirements for marking on the inside of MICROWAVE THERAPY EQUIPMENT are found
in Table 201.C.102.
Table 201.C.102 – Marking on the inside of
MICROWAVE THERAPY EQUIPMENT or its parts
Description of marking Subclause
Non-ionizing radiation symbol 201.7.3.101
Symbols No. 2 and 10 of Table D.2 in Annex D of the general standard. 201.7.3.102
– 18 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
Annex AA
(informative)
Particular guidance and rationale
AA.1 General guidance
This annex provides a concise rationale for the important requirements of the standard and is
intended for those who are familiar with the subject of the standard but who have not
participated in its development. An understanding of the reasons for the main requirements is
considered to be essential for the proper application of the standard. Furthermore as clinical
practice and technology change it is believed that a rationale for the present requirements will
facilitate any revision of the standard necessitated by these developments.
AA.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclause in this particular standard, with
clause and subclause numbers parallel to those in the body of the document.
Subclause 201.1.1 – Scope
The scope was expanded to include additional uses of microwave energy in medical
equipment developed since the first edition. This standard was originally written to cover
microwave devices that were used to gently heat tissue as a means to improve circulation.
New uses for microwave energy include devices that are used to intentionally heat tissue to
temperatures that cause cell death.
Definition 201.3.202 – CONTACT APPLICATOR
These are APPLICATORS that must intentionally touch or be introduced into the patient in order
to be used. The intent of a CONTACT APPLICATOR is to use microwave radiation to heat a
specific area of tissue to a temperature sufficient to cause tissue death. The clinical reason
for this treatment may include (but is not limited to) shrinkage of tissue or treatment of
diseased tissue. Depending on the type of treatment, the patient may or may not be
anesthetized. This definition was created to clearly differentiate it from NON-CONTACT
APPLICATORS.
Definition 201.3.205 – NON-CONTACT APPLICATOR
These are APPLICATORS that are not intended to touch the PATIENT during use. These
APPLICATORS are used to gently heat PATIENT tissue. In general, the PATIENT is awake during
this treatment and able to comment if the heating causes discomfort or pain.
Definition 201.3.207 – RATED OUTPUT POWER
Selection of the power measurement equipment and technique will depend on whether the
output is continuous or pulsed.
Definition 201.3.208 – UNWANTED RADIATION
Microwave energy other than that responsible for creating the desired clinical effect. This
definition allows the creation of requirements and tests to measure this energy so as to
protect tissue that is not in the treatment area. This includes PATIENT tissue as well as that of
the OPERATOR.
+AMD2:2022 CSV © IEC 2022
Subclause 201.4.3.101 – Additional ESSENTIAL PERFORMANCE requirements
If a device does display numerical values representing the output power, then the correct
display of such values is considered ESSENTIAL PERFORMANCE.
Subclause 201.7.3 – Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
The aim of the marking is to protect SERVICE PERSONNEL from UNWANTED RADIATION and notify
them that ELECTROMAGNETIC DISTURBANCE suppression may be degraded during maintenance
or repair.
Subclause 201.7.4.2 – Control devices
As the power delivered to the load depends on the load resistance, a graduation in relative
units is considered to be adequate. If the numeral "0" is displayed, the OPERATOR will expect
zero output at this position of the control.
Subclause 201.8.7.1 – General re
...
IEC 60601-2-6 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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IEC 60601-2-6 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-3378-8
IEC 60601-2-6 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 60601-2-6:2012+AMD1:2016 CSV
© IEC 2016
CONTENTS
FOREWORD. 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 9
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 12
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 13
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 15
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT . 15
201.16 ME SYSTEMS . 15
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 15
202 Electromagnetic compatibility disturbances – requirements and tests . 15
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 . 21
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 9
Table 201.C.101 – Marking on the outside of MICROWAVE THERAPY EQUIPMENT or its
parts . 17
Table 201.C.102 – Marking on the inside of MICROWAVE THERAPY EQUIPMENT or its parts . 17
© IEC 2016
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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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
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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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
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other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
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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.
This consolidated version of the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 60601-2-6 edition 2.1 contains the second edition (2012-04) [documents 62D/985/FDIS and
62D/1008/RVD] and its amendment 1 (2016-04) [documents 62D/1331/FDIS and 62D/1351/RVD].
In this Redline version, a vertical line in the margin shows where the technical content is
modified by amendment 1. Additions are in green text, deletions are in strikethrough red text.
A separate Final version with all changes accepted is available in this publication.
– 4 – IEC 60601-2-6:2012+AMD1:2016 CSV
© IEC 2016
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
with IEC 60601-1:2005+A1:2012.
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.
© IEC 2016
The committee has decided that the contents of the base publication and its amendment 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.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60601-2-6:2012+AMD1:2016 CSV
© IEC 2016
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.
© IEC 2016
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
– 8 – IEC 60601-2-6:2012+AMD1:2016 CSV
© IEC 2016
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
© IEC 2016
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
microwave radiation which is not incident on or in the PATIENT for treatment purposes
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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© IEC 2016
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.
© IEC 2016
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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© IEC 2016
– instructions on how to test the output power of the MICROWAVE THERAPY EQUIPMENT;
– where the MICROWAVE THERAPY EQUIPMENT has an output power control:
MATCHED
• a diagram showing the power output versus the output control setting at the
LOAD;
– information on the precautions to be observed when the warning symbols mentioned in
201.7.3.101 and/or 201.7.3.102 are displayed.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.7.1 * General requirements
Addition to item b):
– with the microwave output not energized but in such a way that the LEAKAGE CURRENTS and
PATIENT AUXILIARY CURRENTS are not affected.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:
201.10.1 X-radiation
This subclause clause of the general standard is not applicable
201.10.2 Alpha, beta, gamma, neutron radiation and other particle radiation
This clause of the general standard is not applicable.
201.10.3 Microwave radiation
Addition:
201.10.3.101 * UNWANTED RADIATION
UNWANTED RADIATION shall not exceed 10 mW/cm at a distance of 1 m from the front of a
NON-CONTACT APPLICATOR and 0,25 m from the rear of a NON-CONTACT APPLICATOR when tested
as described below.
Compliance is checked by the following test:
Adjust the output to the maximum output power specified for each NON-CONTACT APPLICATOR.
Measure the power density of the UNWANTED RADIATION after placing the NON-CONTACT
APPLICATOR at the maximum distance the MANUFACTURER recommends from a suitable
PHANTOM. If a suitable PHANTOM is not specified by the MANUFACTURER, the phantom shall
consist of a cylindrical container 0,20 m diameter x 0,50 m long made of low-loss material, for
example acrylic, filled with a solution of 9 g NaCI per litre of water.
© IEC 2016
201.10.3.102 * Leakage of microwave radiation
The leakage of microwave radiation from the ME EQUIPMENT ENCLOSURE, cables or
waveguides, and cable/waveguide connectors shall not exceed 10 mW/cm when measured
as described below.
Compliance is checked by the following test:
Connect the MICROWAVE THERAPY EQUIPMENT to a matched load and operate it at the rated
output power. Using a calibrated field probe, measure the microwave power density at
various points along the external surfaces of the EQUIPMENT, connectors, and
cables/waveguides.
NOTE Annex AA contains a guide to assist the reader in making repeatable measurements.
201.10.3.103 Limitation of microwave power
The RATED OUTPUT POWER of MICROWAVE THERAPY EQUIPMENT having a single output channel or
multiple output channels that can only be operated one channel at a time shall not exceed
250 W. The rated output power of microwave therapy equipment having multiple output
channels which can be operated simultaneously shall not exceed 125 W per channel.
Compliance is checked by inspection of the markings specified in 201.7.2.101.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT
Addition:
CONTACT APPLICATORS are APPLIED PARTS intended to supply heat to a PATIENT as part of the
intended clinical effect. Disclosure of temperatures is not required.
201.11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable anesthetics
Replacement:
MICROWAVE THERAPY EQUIPMENT shall not be CATEGORY AP or CATEGORY APG ME EQUIPMENT and
thus shall not be used in the presence of flammable anesthetics.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
Any incorporated indication of the output power may be in absolute units or in relative units.
– 14 – IEC 60601-2-6:2012+AMD1:2016 CSV
© IEC 2016
For an absolute indication, the measured output power shall not deviate from the indicated
value by more than ± 20 % of the indicated value.
Compliance is checked by measurement of the output power as follows:
Replace the APPLICATOR with a MATCHED LOAD and measure the maximum output power.
201.12.4 Protection against hazardous output
201.12.4.2 Indication of parameters relevant to safety
Addition:
201.12.4.2.101 * Output indicator
MICROWAVE THERAPY EQUIPMENT shall emit an audible signal when microwave energy is being
produced. The sound level produced shall be at least 30 dBA for NON-CONTACT APPLICATORS
and at least 40 dBA for all other APPLICATORS at a distance of 1 m from the front of the ME
EQUIPMENT.
Compliance is checked by functional check and measurement of the sound level.
Additional subclauses:
201.12.4.101 * Output reduction means
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall provide means to
reduce the power output to 5 % or less of the maximum output power for each range/mode or
to 10 W, whichever is the least.
Compliance is checked by measurement of the output power according to 201.12.1.
201.12.4.102 * Energizing the output
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall be so designed
that the output cannot be energized unless the output control is first set to the minimum
position.
This requirement shall also be met after the interruption and restoration of the mains supply.
Compliance is checked by inspection and functional test.
201.12.4.103 * Adjustable timer
MICROWAVE THERAPY EQUIPMENT employing NON-CONTACT APPLICATORS shall be provided with
an adjustable timer which de-energizes the output after a preselected operating period has
elapsed. The timer shall have a range not exceeding 30 min and an accuracy of
± 1 min.
Compliance is checked by inspection, functional test and measurement of the operating time.
201.12.4.104 De-energizing the output
MICROWAVE THERAPY EQUIPMENT shall have a means to manually de-energize the microwave
output at any time regardless of the status of any automatic control means or timer.
Compliance is checked by functional inspection.
© IEC 2016
201.12.4.105 Maximum power output
When measured immediately after any warming up period specified in the instructions for use,
the maximum output power shall not be greater than the RATED OUTPUT POWER plus 20 %.
Compliance is checked by replacing the APPLICATOR with a MATCHED LOAD, setting any output
controls to maximum and measuring the output power.
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
Clause 13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies, except as follows:
201.15.4 ME EQUIPMENT components and general assembly
Additional subclause:
201.15.4.101 * ENCLOSURES and covers
Any ACCESS COVER or ENCLOSURE, the removal of which can result in the ME EQUIPMENT failing
to comply with the requirement of 201.10.3.102, shall be removable only with the aid of a
TOOL.
Compliance is checked by inspection.
201.16 ME SYSTEMS
Clause 16 of the general standard applies.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the general standard applies:
202 Electromagnetic compatibility disturbances – requirements and tests
IEC 60601-1-2:2007 applies except as follows:
202.4 General requirements
202.4.3 General test conditions
Additional subclause:
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© IEC 2016
202.4.3.101 General test setup
Compliance testing of MICROWAVE THERAPY EQUIPMENT shall occur while radiating into a
suitable PHANTOM as specified by the MANUFACTURER or with the APPLICATOR replaced by a
MATCHED LOAD.
Annexes
The annexes of the general standard apply except as follows:
© IEC 2016
Annex C
(informative)
Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts
Additional requirements for marking on the outside of MICROWAVE THERAPY EQUIPMENT are
found in Table 201.C.101.
Table 201.C.101 – Marking on the outside of
MICROWAVE THERAPY EQUIPMENT or its parts
Description of marking Subclause
RATED OUTPUT POWER 201.7.2.101
MATCHED LOAD 201.7.2.101
Operating frequency 201.7.2.101
Non-ionizing radiation symbol 201.7.2.101
201.C.2 Marking on the inside of ME EQUIPMENT, ME SYSTEMS or their parts
Additional requirements for marking on the inside of MICROWAVE THERAPY EQUIPMENT are found
in Table 201.C.102.
Table 201.C.102 – Marking on the inside of
MICROWAVE THERAPY EQUIPMENT or its parts
Description of marking Subclause
Non-ionizing radiation symbol 201.7.3.101
Symbols No. 2 and 10 of Table D.2 in Annex D of the general standard. 201.7.3.102
– 18 – IEC 60601-2-6:2012+AMD1:2016 CSV
© IEC 2016
Annex AA
(informative)
Particular guidance and rationale
AA.1 General guidance
This annex provides a concise rationale for the important requirements of the standard and is
intended for those who are familiar with the subject of the standard but who have not
participated in its development. An understanding of the reasons for the main requirements is
considered to be essential for the proper application of the standard. Furthermore as clinical
practice and technology change it is believed that a rationale for the present requirements will
facilitate any revision of the standard necessitated by these developments.
AA.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclause in this particular standard, with
clause and subclause numbers parallel to those in the body of the document.
Subclause 201.1.1 – Scope
The scope was expanded to include additional uses of microwave energy in medical
equipment developed since the first edition. This standard was originally written to cover
microwave devices that were used to gently heat tissue as a means to improve circulation.
New uses for microwave energy include devices that are used to intentionally heat tissue to
temperatures that cause cell death.
Definition 201.3.202 – CONTACT APPLICATOR
These are APPLICATORS that must intentionally touch or be introduced into the patient in order
to be used. The intent of a CONTACT APPLICATOR is to use microwave radiation to heat a
specific area of tissue to a temperature sufficient to cause tissue death. The clinical reason
for this treatment may include (but is not limited to) shrinkage of tissue or treatment of
diseased tissue. Depending on the type of treatment, the patient may or may not be
anesthetized. This definition was created to clearly differentiate it from NON-CONTACT
APPLICATORS.
Definition 201.3.205 – NON-CONTACT APPLICATOR
These are APPLICATORS that are not intended to touch the PATIENT during use. These
APPLICATORS are used to gently heat PATIENT tissue. In general, the PATIENT is awake during
this treatment and able to comment if the heating causes discomfort or pain.
Definition 201.3.207 – RATED OUTPUT POWER
Selection of the power measurement equipment and technique will depend on whether the
output is continuous or pulsed.
Definition 201.3.208 – UNWANTED RADIATION
Microwave energy other than that responsible for creating the desired clinical effect. This
definition allows the creation of requirements and tests to measure this energy so as to
protect tissue that is not in the treatment area. This includes PATIENT tissue as well as that of
the OPERATOR.
© IEC 2016
Subclause 201.4.3.101 – Additional ESSENTIAL PERFORMANCE requirements
If a device does display numerical values representing the output power, then the correct
display of such values is considered ESSENTIAL PERFORMANCE.
Subclause 201.7.3 – Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
The aim of the marking is to protect SERVICE PERSONNEL from UNWANTED RADIATION and notify
them that ELECTROMAGNETIC DISTURBANCE suppression may be degraded during maintenance
or repair.
Subclause 201.7.4.2 – Control devices
As the power delivered to the load depends on the load resistance, a graduation in relative
units is considered to be adequate. If the numeral "0" is displayed, the OPERATOR will expect
zero output at this position of the control.
Subclause 201.8.7.1 – General requirements
As small LEAKAGE CURRENTS at mains frequency cannot easily be measured in the presence of
high frequency power, the high-frequency generator is disabled during the tests.
Subclause 201.10.3.101 – UNWANTED RADIATION
This requirement limits UNWANTED RADIATION and creates a "safety zone" around a NON-
CONTACT APPLICATOR. In NORMAL USE, the OPERATOR is not continuously exposed to microwave
radiation. During positioning of the PATIENT, and the NON-CONTACT APPLICATOR, the output is
supposed to be switched off, and the instructions for use warn the OPERATOR to be more than
1.5 meters from a
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