EN IEC 80601-2-60:2020

SLOVENSKI STANDARD
01-junij-2020
Nadomešča:
SIST EN 80601-2-60:2015
Medicinska električna oprema - 2-60. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti zobozdravstvene opreme (IEC 80601-2-60:2019)
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and
essential performance of dental equipment (IEC 80601-2-60:2019)
Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Dental-Geräten (IEC 80601-2-
60:2019)
Appareils électromédicaux - Partie 2-60: Exigences particulères pour la sécurité de base
et les performances essentielles des équipements dentaires (IEC 80601-2-60:2019)
Ta slovenski standard je istoveten z: EN IEC 80601-2-60:2020
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 80601-2-60

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.01 Supersedes EN 80601-2-60:2015 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-60: Particular requirements
for the basic safety and essential performance of dental
equipment
(IEC 80601-2-60:2019)
Appareils électromédicaux - Partie 2-60: Exigences Medizinische elektrische Geräte - Teil 2-60: Besondere
particulères pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des équipements dentaires wesentlichen Leistungsmerkmale von Dental-Geräten
(IEC 80601-2-60:2019) (IEC 80601-2-60:2019)
This European Standard was approved by CENELEC on 2019-08-01. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-60:2020 E

European foreword
The text of document 62D/1683/FDIS, future edition 2 of IEC 80601-2-60, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 80601-2-60:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
document have to be withdrawn
This document supersedes EN 80601-2-60:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association.
Endorsement notice
The text of the International Standard IEC 80601-2-60:2019 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60038 NOTE Harmonized as EN 60038
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 61810-7:2006 NOTE Harmonized as EN 61810-7:2006 (not modified)
ISO 7494-2:2015 NOTE Harmonized as EN ISO 7494-2:2015 (not modified)
ISO 13732-1:2006 NOTE Harmonized as EN ISO 13732-1:2008 (not modified)
ISO 17664:2017 NOTE Harmonized as EN ISO 17664:2017 (not modified)
ISO 18397:2016 NOTE Harmonized as EN ISO 18397:2016 (not modified)
ISO 21530:2004 NOTE Harmonized as EN ISO 21530:2004 (not modified)

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Clause 2 of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replace
IEC 60825-1 2014 Safety of laser products - Part 1: EN 60825-1 2014
Equipment classification and requirements
+EN 60825-
1:2014/AC:2017-06
+A11 2020
Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
IEC 60601-2-2 2017 Medical electrical equipment - Part 2-2: EN IEC 60601-2-2 2018
Particular requirements for the basic safety
and essential performance of high
frequency surgical equipment and high
frequency surgical accessories
IEC 60601-2-22 2007 Medical electrical equipment - Part 2-22: EN 60601-2-22 2013
Particular requirements for basic safety
and essential performance of surgical,
cosmetic, therapeutic and diagnostic laser
equipment
IEC 60601-2-57 2011 Medical electrical equipment - Part 2-57: EN 60601-2-57 2011
Particular requirements for the basic safety
and essential performance of non-laser
light source equipment intended for
therapeutic, diagnostic, monitoring and
cosmetic/aesthetic use
IEC 60664-1 2007 Insulation coordination for equipment EN 60664-1 2007
within low-voltage systems - Part 1:
Principles, requirements and tests
Publication Year Title EN/HD Year
IEC 60664-4 2005 Insulation coordination for equipment EN 60664-4 2006
within low-voltage systems - Part 4:
Consideration of high-frequency voltage
stress
+EN 60664-2006
4:2006/corrigendum
Oct. 2006
IEC 61180 2016 High-voltage test techniques for low-EN 61180 2016
voltage equipment - Definitions, test and
procedure requirements, test equipment
IEC 61810-1 2015 Electromechanical elementary relays - Part EN 61810-1 2015
1: General and safety requirements
ISO 1942 2009 Dentistry -- Vocabulary EN ISO 1942 2010
ISO 14457 2017  EN ISO 14457 2017

IEC 80601-2-60
Edition 2.0 2019-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-60: Particular requirements for the basic safety and essential performance

of dental equipment
Appareils électromédicaux –
Partie 2-60: Exigences particulières pour la sécurité de base et les performances

essentielles des équipements dentaires

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-7049-3

– 2 – IEC 80601-2-60:2019 © IEC 2019
CONTENTS
FOREWORD . 3
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 10
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 . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 23
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
201.101 Cordless HAND-HELD and foot-operated control devices . 25
Annexes . 26
Annex AA (informative) Particular guidance and rationale . 27
Bibliography . 39
Index of defined terms used in this document . 40

Figure AA.1 – Example of APPLIED PARTS for DENTAL EQUIPMENT . 28
Figure AA.2 – Calculation of LEAKAGE CURRENT . 29
Figure AA.3 – Insulation problem of commutator DENTAL ELECTRICAL MOTOR . 31
Figure AA.4 – Loading fan construction . 37
Figure AA.5 – Load diagram with loading fan . 37

Table 201.101 – Test voltages for solid insulation for SECONDARY CIRCUITS according to
201.8.9.1.12 . 12
Table 201.102 – Determination of TENSILE SAFETY FACTOR . 18
Table 201.103 – Mass distribution. 19
Table 201.104 – Allowable maximum temperatures for the OPERATOR SIDE of DENTAL
HANDPIECES . 20
Table AA.1 – RATED impulse voltage for equipment energized directly from the low-
voltage mains . 32

IEC 80601-2-60:2019 © IEC 2019 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-60: Particular requirements for the basic safety
and essential performance of dental equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 80601-2-60 has been prepared by a Joint Working Group of
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and subcommittee 6: Dental equipment, of ISO technical
committee 106: Dentistry.
This second edition cancels and replaces the first edition published in 2012. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

– 4 – IEC 80601-2-60:2019 © IEC 2019
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1683/FDIS 62D/1691/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
This publication is published as a double logo standard.
In this document, 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 document, 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 document are preceded by the term “Clause” followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, 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 document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this document;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– “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 80601-2-60:2019 © IEC 2019 – 5 –
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – IEC 80601-2-60:2019 © IEC 2019
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-60: Particular requirements for the basic safety
and essential performance of dental equipment

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF
DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES AND DENTAL OPERATING LIGHTS,
hereafter referred to as DENTAL EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
the scope of this document are not covered by specific requirements in this document except
in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements for DENTAL EQUIPMENT (as defined in 201.3.202.)
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 and Clause 201.2 of this particular standard.

IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601-1 series apply as published.
___________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.

IEC 80601-2-60:2019 © IEC 2019 – 7 –
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 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are 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 document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this document 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 document" 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.

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201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and
requirements
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 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
IEC 60601-2-22:2007, Medical electrical equipment – Part 2-22: Particular requirements for
basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
equipment
IEC 60601-2-22:2007/AMD1:2012
IEC 60601-2-57:2011, Medical electrical equipment – Part 2-57: Particular requirements for
the basic safety and essential performance of non-laser light source equipment intended for
therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 60664-1:2007, Insulation coordination for equipment within low-voltage systems – Part 1:
Principles, requirements and tests
IEC 60664-4:2005, Insulation coordination for equipment within low-voltage systems – Part 4:
Consideration of high-frequency voltage stress
IEC 61180:2016, High-voltage test techniques for low-voltage equipment – Definitions, test
and procedure requirements, test equipment
IEC 61810-1:2015, Electromechanical elementary relays – Part 1: General and safety
requirements
ISO 1942:2009, Dentistry – Vocabulary
ISO 14457: 2017, Dentistry – Handpieces and motors
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, IEC 60601-2-2:2017 and ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp

IEC 80601-2-60:2019 © IEC 2019 – 9 –
NOTE An index of defined terms is found beginning on page 40.
Addition:
201.3.201
DENTAL ELECTRICAL MOTOR
HAND-HELD part of the DENTAL HANDPIECE electrically powered by the DENTAL UNIT
201.3.202
DENTAL EQUIPMENT
ME EQUIPMENT with any combination of DENTAL HANDPIECES, DENTAL UNITS,
DENTAL PATIENT CHAIRS and DENTAL OPERATING LIGHTS
201.3.203
DENTAL HANDPIECE
HAND-HELD instrument used in dentistry for use in PATIENT treatment and connected to the
DENTAL UNIT
201.3.204
DENTAL OPERATING LIGHT
device designed for use by an OPERATOR for illuminating the oral cavity, consisting of a
luminaire and one or more lamps
201.3.205
DENTAL PATIENT CHAIR
device designed to support and position the PATIENT for treatment and therefore provided with
a range of movements
201.3.206
DENTAL UNIT
assembly of devices designed to provide utilities and amenities for dental treatment, such as
compressed air, water or other liquids, suction, electricity, hand- or foot-activated controllers,
work surface(s), tray support(s), cuspidor or gasses
Note 1 to entry: This device is usually fitted with conveniently oriented instrument holders and controls, and
consists of interconnected sub-units of DENTAL EQUIPMENT and instruments providing a functional unit for dental use.
201.3.207
OPERATOR SIDE OF DENTAL HANDPIECE
part of DENTAL HANDPIECE which is designed to be handheld by the OPERATOR in NORMAL USE
201.3.208
PATIENT SIDE OF DENTAL HANDPIECE
part of DENTAL HANDPIECE which is designed to be introduced into the oral cavity where all
parts of the DENTAL HANDPIECE within 80 mm of the tip shall be considered as an APPLIED PART
201.3.209
CORD-CONNECTED MOBILE PARTS OF DENTAL EQUIPMENT
DENTAL EQUIPMENT which is permanently connected to FIXED parts of DENTAL EQUIPMENT and is
equipped with castor or wheels for positioning by the OPERATOR and which is intended for the
use on an even, obstacle free, floor

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201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Replacement:
DENTAL EQUIPMENT does not have ESSENTIAL PERFORMANCE unless specified by the
manufacturer.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 Ambient temperature, humidity, atmospheric pressure
Amendment of item a):
After the ME EQUIPMENT to be tested has been set up for NORMAL USE (according to 5.7 of
general standard), tests are performed within the range of environmental conditions indicated
in the technical description (see 7.9.3.1 of general standard) but at least at one temperature
within an ambient temperature range +10 °C to 35 °C.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 Protection against electric shock
Replacement:
ME EQUIPMENT energized from an external electrical power source shall be classified as
CLASS I ME EQUIPMENT or CLASS II ME EQUIPMENT (see 7.2.6 of IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012). Other ME EQUIPMENT shall be classified as INTERNALLY
POWERED ME EQUIPMENT.
INTERNALLY POWERED ME EQUIPMENT having a means of connection to a SUPPLY MAINS shall
comply with the requirements for CLASS I ME EQUIPMENT or CLASS II ME EQUIPMENT while so
connected, and with the requirements for INTERNALLY POWERED ME EQUIPMENT while not so
connected.
APPLIED PARTS of DENTAL EQUIPMENT which are connected through water lines shall be
considered as TYPE B APPLIED PARTS.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:

IEC 80601-2-60:2019 © IEC 2019 – 11 –
201.7.2.10 APPLIED PARTS
Addition:
If a DENTAL EQUIPMENT has only one APPLIED PART or APPLIED PARTS of different degree of
protection against electric shock, it is sufficient to place the appropriate symbol of the lowest
degree of protection against electrical shock once on the ENCLOSURE of the DENTAL EQUIPMENT.
APPLIED PARTS with higher degree of protection shall be marked individually.
*
201.7.2.11 Mode of operation
Addition:
For DENTAL HANDPIECES, no marking is necessary.
For DENTAL ELECTRICAL MOTORS, no marking is necessary.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101 * Additional instructions for use
For DENTAL HANDPIECES intended for non-CONTINUOUS OPERATION, the duty cycle shall be
provided.
For DENTAL ELECTRICAL MOTORS no explanation of the duty cycle is necessary.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
Additional subclause:
201.8.4.101 * NEUTRAL ELECTRODE monitoring circuit
The requirements specified in 201.8.4.101 of IEC 60601-2-2:2017 do not apply for HIGH
FREQUENCY SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50W.
201.8.5.2 Separation of PATIENT CONNECTIONS
Additional subclause:
201.8.5.2.101 * APPLIED PARTS that form one single APPLIED PART
In a DENTAL EQUIPMENT the DENTAL HANDPIECES may be considered as multiple functions of
one APPLIED PART or PATIENT CONNECTIONS of one APPLIED PART.
The combination of several APPLIED PARTS to form one single APPLIED PART is only permitted if
no HAZARDOUS SITUATION occurs when applying several APPLIED PARTS concurrently.

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201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
201.8.7.1 * General requirements
Addition:
bb) Water columns inside of an APPLIED PARTS or its multiple connections can be considered
as electric impedances according to their geometric dimensions and the resistance of the
water. If this method is used the MANUFACTURER shall state the maximum fluid
conductivity in the instructions for use and technical description (e.g. installation
instructions).
Additional subclause:
201.8.7.3.101 * Thermal effects of HF LEAKAGE CURRENTS
Requirements and tests 1) and 2) specified in 201.8.7.3.101 of IEC 60601-2-2:2017 do not
apply for HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W and
intended for use without a NEUTRAL ELECTRODE.
201.8.8.3 * Dielectric strength
Addition:
For circuits according to 201.8.9.1.12 SECONDARY CIRCUITS, the test voltages indicated in
Table 201.101 shall be used for testing solid insulation:
Table 201.101 – Test voltages for solid insulation
for SECONDARY CIRCUITS according to 201.8.9.1.12
PEAK WORKING VOLTAGE One MOPP Two MOPP
(U) in V U in V RMS U in V RMS
≤ 71 500 500
≤ 50 (RMS)
For higher PEAK WORKING VOLTAGES, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012
shall be applied.
201.8.9 * CREEPAGE DISTANCES and AIR CLEARANCES
Amendment:
For CREEPAGE DISTANCES and AIR CLEARANCES, 8.9 of the general standard shall be used
without modification or with the following changes.
Alternatively CREEPAGE DISTANCES and AIR CLEARANCES of this particular standard may be
applied. In this case, 8.9 of the general standard applies except as follows:
201.8.9.1 Values
201.8.9.1.2 CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1
The subclause of the general standard does not apply.

IEC 80601-2-60:2019 © IEC 2019 – 13 –
201.8.9.1.3 CREEPAGE DISTANCES across glass, mica, ceramic and similar materials
Amendment:
For SECONDARY CIRCUITS, the subclause of the general standard does not apply.
201.8.9.1.4 Minimum CREEPAGE DISTANCE
Amendment:
For SECONDARY CIRCUITS, the subclause of the general standard does not apply.
201.8.9.1.6 Interpolation
Amendment:
For SECONDARY CIRCUITS, the subclause of the general standard does not apply.
201.8.9.1.7 Material groups classification
Amendment:
For SECONDARY CIRCUITS, the subclause of the general standard does not apply.
201.8.9.1.8 Pollution degree classification
Amendment:
For SECONDARY CIRCUITS, 4.6.2 of IEC 60664-1:2007 applies.
201.8.9.1.9 Overvoltage category classification
The subclause of the general standard does not apply.
201.8.9.1.11 SUPPLY MAINS overvoltage
Replacement:
This particular standard relates to overvoltage category II according to IEC 60664-1:2007.
201.8.9.1.12 SECONDARY CIRCUITS
Replacement:
For separation between SUPPLY MAINS and SECONDARY CIRCUITS two MOPP according to
Table 12 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 applies.
For the separation between SUPPLY MAINS and APPLIED PARTS two MOPP according to Table 12
of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 shall be applied.
Within SECONDARY CIRCUITS, for the separation within and between APPLIED PARTS of
DENTAL EQUIPMENT for AIR CLEARANCES and CREEPAGE DISTANCES, the following apply:
a) IEC 60664-1:2007 for RATED frequencies up to 30 kHz with the following tables and
conditions:
The DENTAL UNIT, DENTAL PATIENT CHAIRS and DENTAL OPERATING LIGHTS shall be capable of
withstanding 4 kV withstand impulse voltage in SUPPLY MAINS circuits.

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Table F.2 of IEC 60664-1:2007 – Clearances to withstand transient overvoltages
• Condition A inhomogeneous field, pollution degree 2, up to a maximum impulse
withstand voltage of 1,0 kV.
• For higher voltages IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 shall be
applied (Table 12 of general standard).
The transient impulse voltage of maximum 1 kV shall be checked by testing as follows: Apply
a test voltage of 4 kV of 1,2/50 µs waveform to the primary circuit (SUPPLY MAINS). Verify that
SECONDARY CIRCUIT. The waveform has to be in
a limit of 1 kV is not exceeded in the
accordance with IEC 61180:2016. The generator shall comply with IEC 61180:2016 (internal
resistance of 2 Ω).
Table F.7.a of IEC 60664-1:2007 – Clearances to withstand steady-state voltages,
temporary overvoltages or recurring peak voltages
• Condition A inhomogeneous field, voltage (peak voltage) up to a maximum of 2 kV.
• For higher voltages IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 shall be
applied (Table 12 of general standard).
Temporary voltages are not to be taken into account for SECONDARY CIRCUITS.
Table F.4 of IEC 60664-1:2007 – CREEPAGE DISTANCES to avoid failure due to tracking
• Pollution degree 2, voltage (RMS-value) up to 2 kV
• For higher voltages the IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 shall be
applied (Table 12 of general standard).
The values for printed wiring materials of Table F.4 do not apply.
b) IEC 60664-4:2005 for RATED frequencies above 30 kHz and up to 10 MHz with the
following tables and conditions:
Table 1 of IEC 60664-4:2005: Minimum values of clearances in air at atmospheric
pressure for inhomogeneous field conditions, in connection with 4.4.3 of IEC 60664-
4:2005 and Clause 8 of the general standard
Table 2 of IEC 60664-4:2005: Minimum values of CREEPAGE DISTANCES for different
frequency ranges, in connection with 5.2 of IEC 60664-4:2005 and Clause 8 of the general
standard
NOTE 1 Terminology and definitions of IEC 60664 (all parts) apply.
Pollution degree 3 shall be applied if a higher pollution degree is expected when cooling fans
are incorporated.
NOTE 2 An appropriate air filter can reduce pollution degree to 2.
In any case the greater value of Tables F.2, F.7.a and F.4 of IEC 60664-1:2007 and Tables 1
and 2 of IEC 60664-4:2005 has to be selected.
For RATED frequencies above 30 kHz and up to 10 MHz, values have to be checked with
Tables F.2, F.4 and F.7a of IEC 60664-1:2007 and Tables 1 and 2 of IEC 60664-4:2005. The
greater value of IEC 60664-1:2007 and IEC 60664-4:2005 has to be selected.
Minimum AIR CLEARANCE and CREEPAGE DISTANCE is 0,2 mm for BASIC INSULATION.
AIR CLEARANCES and CREEPAGE DISTANCES are minimum values, account for
Since
manufacturing and component tolerances.
CREEPAGE DISTANCES and AIR CLEARANCE shall be determined based on the rules of the
IEC 60664 series. The values given in tables are BASIC INSULATION or
SUPPLEMENTARY INSULATION.
1) MOPP is equivalent to one BASIC INSULATION for AIR CLEARANCES and CREEPAGE DISTANCES.

IEC 80601-2-60:2019 © IEC 2019 – 15 –
2) MOPP is equivalent to
• DOUBLE INSULATION which is sum of BASIC INSULATION and SUPPLEMENTARY INSULATION
for CREEPAGE DISTANCE;
• REINFORCED INSULATION which is two times BASIC INSULATION for CREEPAGE DISTANCE;
• DOUBLE INSULATION which is the sum of BASIC INSULATION and
SUPPLEMENTARY INSULATION for AIR CLEARANCE;
• REINFORCED INSULATION which is dimensioned as specified in Table F.1 or Table F.7a
of IEC 60664-1:2007 to withstand 160 % of the withstand voltage required for
BASIC INSULATION for AIR CLEARANCE for DOUBLE INSULATION where BASIC INSULATION and
SUPPLEMENTARY INSULATION cannot be tested separately. The larger value of Table F.1
and Table F.7a of IEC 60664-1:2007 applies.
C) AIR CLEARANCE and CREEPAGE DISTANCE for SEPARATION DEVICES applied for separation of
PEAK
voltages up to 50 V AC / 71 V
1) For pollution degree 2:
SEPARATION DEVICES separating voltages up to 50 V AC / 71 V PEAK
For the
AIR CLEARANCE is 0,2 mm/0,4 mm (BASIC INSULATION/DOUBLE INSULATION). For
CREEPAGE DISTANCE Table F.4 of IEC 60664-1:2007 applies.
The test voltage for the SEPARATION DEVICES is 500 V.
2) For pollution degree 3:
For the SEPARATION DEVICES separating voltages up to 50 V AC / 71 V PEAK
AIR CLEARANCE is 0,8 mm/1,6 mm (BASIC INSULATION/DOUBLE INSULATION). Alternatively
an encapsulated SEPARATION DEVICE shall be used according to IEC 61810-1 category
RT III with AIR CLEARANCE 0,2 mm/0,4 mm (BASIC INSULATION/DOUBLE INSULATION). For
CREEPAGE DISTANCE Table F.4 of IEC 60664-1:2007 applies.
SEPARATION DEVICES is 500 V.
The test voltage for the
NOTE 3 SEPARATION DEVICES are for example: relays, optical couplers or magnetic couplers.
201.8.9.1.13 PEAK WORKING VOLTAGES above 1 400 V peak or DC
The subclause of the general standard does not apply.
201.8.9.1.14 Minimum CREEPAGE DISTANCES for two MEANS OF OPERATOR PROTECTION
Amendment:
The subclause of the general standard does not apply for SECONDARY CIRCUITS.
201.8.9.1.15 CREEPAGE DISTANCES and AIR CLEARANCES for DEFIBRILLATION-PROOF
APPLIED PARTS
The subclause of the general standard applies.
201.8.9.2 Application
Addition to item b):
for pollution degree 3, 6.2 of IEC 60664-1:2007 applies.
201.8.9.4 Measurement of CREEPAGE DISTANCES AND AIR CLEARANCES
Addition:
For pollution degree 3, 6.2 of 60664-1:2007 applies in addition.

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201.8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated
control devices
Additional subclause:
201.8.10.4.101 * Footswitches
For any HF SURGICAL EQUIPMENT that is incorporated in the DENTAL EQUIPMENT,
201.8.10.4.101.4 of IEC 60601-2-2:2017 does not apply if:
– the RATED OUTPUT POWER of the HF SURGICAL EQUIPMENT does not exceed 50 W;
– the ACTIVE ELECTRODE of the HF SURGICAL EQUIPMENT is prevented from being energised
while it is in its instrument holder, and;
– the instructions for use prohibit use of the HF SURGICAL EQUIPMENT in operating theatres.
201.8.11 MAINS PARTS, components and layout
201.8.11.5 * Mains fuses and OVER-CURRENT RELEASES
Addition:
Devices with fuses in phase and neutral line may be integrated into the DENTAL UNIT
(sub-devices, embedded devices). They shall be connected behind the mains fuse of the
PERMANENTLY INSTALLED DENTAL EQUIPMENT. For such integrated devices MAINS VOLTAGES shall
not be accessible by SERVICE PERSONNEL without the use of a TOOL.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies except as follows:
201.9.4.2.1 Instability in transport position
Addition:
Subclause 9.4.2.1 of the general standard is not applicable for CORD-CONNECTED MOBILE PARTS
OF DENTAL EQUIPMENT.
201.9.4.2.2 *Instability excluding transport position
Addition:
On CORD-CONNECTED MOBILE PARTS OF DENTAL EQUIPMENT no warning notices are necessary
when the 5° tipping test is passed. In addition, no information or warning notices on this
matter are necessary in the instructions for use.
The test procedure given in 9.4.2.2 of the general standard for the 10° tipping test is not
CORD-CONNECTED MOBILE PARTS OF D
...