IEC 80601-2-60:2012

IEC 80601-2-60
Edition 1.0 2012-02
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

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IEC 80601-2-60
Edition 1.0 2012-02
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
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 11.040.01 ISBN 978-2-88912-914-0

– 2 – 80601-2-60 © IEC:2012
CONTENTS
FOREWORD . 3
201.1 Scope, object and related standards. 5
201.2 Normative references . 6
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 . 10
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201.13 HAZARDOUS SITUATIONS and fault conditions . 20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 ME SYSTEMS. 21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
201.101 Cordless HAND-HELD and foot-operated control devices . 21
Annexes . 21
Annex AA (informative) Particular guidance and rationale . 22
Bibliography . 31
Index of defined terms used in this particular standard. 32

Figure AA.1 – Example of APPLIED PARTS for DENTAL EQUIPMENT . 23
Figure AA.2 – Calculation of LEAKAGE CURRENT . 24
Figure AA.3 – Insulation problem of commutator DENTAL ELECTRICAL MOTOR . 25
Figure AA.4 – Loading fan construction. 29
Figure AA.5 – Load diagram with loading fan . 30

Table 201.101 – Test voltages for solid insulation for SECONDARY CIRCUITS according to
201.8.5.2 . 10
Table 201.102 – Determination of TENSILE SAFETY FACTOR . 15
Table 201.103 – Mass distribution . 16
Table 201.104 – Allowable maximum temperatures for DENTAL HANDPIECE . 17

80601-2-60 © IEC:2012 – 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,
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Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
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agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
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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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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
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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 80601-2-60 has been prepared by a Joint Working Group of
subcommittee 62D: Electrical equipment in medical practice of IEC technical committee 62:
Electrical equipment in medical practice and subcommittee 6: Dental equipment of ISO
technical committee 106: Dentistry.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/964/FDIS 62D/984/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. In ISO, the standard has been approved by 16
P-members out of 17 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

– 4 – 80601-2-60 © IEC:2012
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.
80601-2-60 © IEC:2012 – 5 –
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
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard 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.
Excluded are amalgamators, sterilizers and dental X-ray 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.
AZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
H
within the scope of this standard are not covered by specific requirements in this standard
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.
2) 3)
IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10 do not apply. All other published
collateral standards in the IEC 60601-1 series apply as published.
___________
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
2)
IEC 60601-1-9:2007, Medical electrical equipment – Part 1-9: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for environmentally conscious design
3)
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop
controllers
– 6 – 80601-2-60 © IEC:2012
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”
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:

80601-2-60 © IEC:2012 – 7 –
Replacement:
IEC 60664-1:2007, Insulation coordination for equipment within low-voltage systems – Part 1:
Principles, requirements and tests
IEC 60825-1, Safety of laser products – Part 1: Equipment classification and requirements
Addition:
IEC 60601-2-2:2009, 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, therpeutic and diagnostic laser
equipment
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 60664-4:2005, Insulation coordination for equipment within low-voltage systems – Part 4:
Consideration of high-frequency voltage stress
IEC 61180-1, High-voltage test techniques for low-voltage equipment – Part 1: Definitions,
test and procedure requirements
IEC 61180-2, High-voltage test techniques for low-voltage equipment – Part 2: Test
equipment
IEC 61810-1:2008, Electromechanical elementary relays – Part 1: General requirements
IEC 62471, Photobiological safety of lamps and lamp systems
ISO 1942, Dentistry – Vocabulary
ISO 7785-2, Dental handpieces – Part 2: Straight and geared angle handpieces
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-2-2:2009 and ISO 1942 apply, except as follows:
NOTE An index of defined terms is found beginning on page 31
Addition:
201.3.201
DENTAL ELECTRICAL MOTOR
handheld 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

– 8 – 80601-2-60 © IEC:2012
201.3.203
DENTAL HANDPIECE
handheld 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
device through which electrical power and/or various fluids or gasses are supplied to a
number of DENTAL HANDPIECE S and devices
Note to entry It 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
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
DENTAL EQUIPMENT does not have ESSENTIAL PERFORMANCE.
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), tests
are performed within the range of environmental conditions indicated in the technical
description (see 7.9.3.1) but at least at one temperature within an ambient temperature range
+10 °C to 35 °C.
80601-2-60 © IEC:2012 – 9 –
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 (IEC 60601-1:2005)). 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
INTERNALLY POWERED ME EQUIPMENT while not so
connected, and with the requirements for
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:
201.7.2.10 APPLIED PARTS
Addition:
If a DENTAL EQUIPMENT has only one APPLIED PART or APPLIED PARTS of all the same degree of
protection against electric shock, it is sufficient to place the appropriate symbol once on the
outside of the DENTAL EQUIPMENT.
*
201.7.2.11 Mode of operation
Addition:
For DENTAL ELECTRICAL MOTORS no marking is necessary.
For DENTAL HANDPIECES no marking is necessary, if the RISK ASSESSMENT gives proof that the
RISK is acceptable.
DENTAL HANDPIECES which incorporate lasers or are connected to lasers shall satisfy relevant
requirements of IEC 60601-2-22.
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 ELECTRICAL MOTORS no explanation of the duty cycle is necessary.
For DENTAL HANDPIECES no explanation of the duty cycle is necessary, if the RISK ASSESSMENT
gives proof that the RISK is acceptable.

– 10 – 80601-2-60 © IEC:2012
DENTAL HANDPIECES which incorporate lasers or are connected to lasers shall satisfy relevant
requirements of IEC 60601-2-22.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies except as follows:
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.
APPLIED PARTS to form one single APPLIED PART is only permitted if
The combination of several
no HAZARD occurs when applying several APPLIED PARTS concurrently.
201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
201.8.7.1 * General requirements
Addition:
aa) Water columns inside of an APPLIED PARTS or its multiple connections are 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).
201.8.8.3 * Dielectric strength
Addition:
For circuits according to 201.8.9.1.12 for 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 One Two
WORKING MOPP MOPP
VOLTAGE U in RMS U in RMS
(U )
500 500
≤ 71
For higher working voltages IEC 60601-1:2005 shall be applied.
201.8.9 * CREEPAGE DISTANCES and AIR CLEARANCES
For CREEPAGE DISTANCES and AIR CLEARANCES Subclause 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 Subclause 8.9 of the general standard applies except as follows:

80601-2-60 © IEC:2012 – 11 –
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.
201.8.9.1.3 CREEPAGE DISTANCES across glass, mica, ceramic and similar materials
For SECONDARY CIRCUITS the subclause of the general standard does not apply.
201.8.9.1.4 Minimum CREEPAGE DISTANCE
For SECONDARY CIRCUITS the subclause of the general standard does not apply.
201.8.9.1.5 ME EQUIPMENT RATED for high altitudes
Addition:
For SECONDARY CIRCUITS Table A.2 – Altitude correction factors of IEC 60664-1:2007 applies.
201.8.9.1.6 Interpolation
For SECONDARY CIRCUITS the subclause of the general standard does not apply.
201.8.9.1.7 Material groups classification
For SECONDARY CIRCUITS the subclause of the general standard does not apply.
201.8.9.1.8 Pollution degree classification
For SECONDARY CIRCUITS subclause 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.
201.8.9.1.10 AIR CLEARANCE for MAINS PARTS
Replacement:
Tables 13 and 14 of the general standard apply.
For MAINS PARTS operating on RATED MAINS VOLTAGES up to 300 V, the required AIR CLEARANCE
shall be the value in Table 13 for the r.m.s. or d.c. RATED MAINS VOLTAGE for
• 150 V < NOMINAL MAINS VOLTAGE ≤ 300 V (MAINS TRANSIENT VOLTAGE 2 500 V) or
• 300 V < NOMINAL MAINS VOLTAGE ≤ 600 V (MAINS TRANSIENT VOLTAGE 4 000V)
plus the additional AIR CLEARANCE in Table 14 for the PEAK WORKING VOLTAGE for
• 150 V r.m.s. or 210 V dc < NOMINAL MAINS VOLTAGE ≤ 300 V r.m.s. or 420 V d.c.
UPPLY MAINS overvoltage
201.8.9.1.11 S
Replacement:
This particular standard relates to overvoltage category II according to IEC 60664-1:2007.

– 12 – 80601-2-60 © IEC:2012
201.8.9.1.12 SECONDARY CIRCUITS
Replacement:
For separation between mains and SECONDARY CIRCUITS two MOPP according to Table 12 of
IEC 60601-1 applies.
For the separation between mains and APPLIED PARTS two MOPP according to Table 12 of
IEC 60601-1 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 and DENTAL OPERATING LIGHT shall be capable of withstanding 4 kV
withstand impulse voltage in mains supply circuits.
Table F.2 – 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 shall be applied (Table 12 of general standard).
The transient impulse voltage of max. 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 (mains). Verify that a limit of 1 kV
is not exceeded in the secondary circuit. The waveform has to be in accordance with
IEC 61180-1. The generator must comply with IEC 61180-2 (internal resistance of 2 Ω).
Table F.7.a –Clearances to withstand steady-state voltages, temporary voltages 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 shall be applied (Table 12 of general standard).
Temporary voltages are not to be taken into account for SECONDARY CIRCUITS.
Table F.4 – 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 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: Minimum values of clearances in air at atmospheric pressure for inhomogeneous
field conditions, in connection with subclause 4.4.3, Dimensioning of clearances
inhomogeneous field conditions, and Clause 8, Non-sinusoidal voltages
Table 2: Minimum values of creepage distances for different frequency ranges, in
connection with subclause 5.2, Dimensioning of creepage distances, and Clause 8,
Non-sinusoidal voltages
NOTE 1 Terminology and definitions of the IEC 60664 series apply.

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Pollution degree 3 shall be applied if a higher pollution degree expected when cooling fans are
incorporated.
NOTE 2 An appropriate air filter may 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.7.a 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.
Since AIR CLEARANCES and CREEPAGE DISTANCES are minimum values, account for
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.
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 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 applies.
C) AIR CLEARANCE and CREEPAGE DISTANCE for relays applied for separation of voltages up to
50 V AC
1) For pollution degree 2:
For the relays´ switching elements separating voltages up to 50 V AC 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.
For open contact the test voltage is 500 V.
2) For pollution degree 3:
For the relays´ switching elements separating voltages up to 50 V AC AIR CLEARANCE is
0,8 mm/1,6 mm (basic insulation/double insulation). Alternatively an encapsulated
relay 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.
For open contact the test voltage is 500 V.
201.8.9.1.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.c.
The subclause of the general standard does not apply.

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201.8.9.1.14 Minimum CREEPAGE DISTANCES for two MEANS OF OPERATOR PROTECTION
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:
b) for pollution degree 3 subclause 6.2 of IEC 60664-1:2007 applies.
201.8.9.4 Measurement of CREEPAGE DISTANCES AND AIR CLEARANCES
Addition:
For pollution degree 3 subclause 6.2 of 60664-1:2007 applies in addition.
201.8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated
control devices
201.8.10.4.101 * Footswitch
For any HF SURGICAL EQUIPMENT that is incorporated in the DENTAL EQUIPMENT,
201.8.10.4.101.4 of IEC 60601-2-2:2009 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.
NOTE 201.8.10.4.101.4 of IEC 60601-2-2 specifies a minimum actuating force of 10 N for footswitches."
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:
201.9.8.2 * TENSILE SAFETY FACTOR
Addition:
If the material TENSILE STRENGTH is quantifiable and known accurately, Table 201.102 applies.

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Table 201.102 – Determination of TENSILE SAFETY FACTOR
Situation
Minimum TENSILE
a
SAFETY FACTOR
No. System Part Elongation
b
1 Support system parts not Metallic material having a 2,5
impaired by wear specific elongation at break
equal to or greater than 5 %
b
2 Support system parts not Metallic material having a 4
impaired by wear specific elongation at break of
less than 5 %
d
3 Support system parts Metallic material having a 5
c
impaired by wear and no specific elongation at break
MECHANICAL PROTECTIVE equal to or greater than 5 %
DEVICE
b
4 Support system parts Metallic material having a 8
c
impaired by wear and no specific elongation at break of
MECHANICAL PROTECTIVE less than 5 %
DEVICE
b
5 Support system parts Metallic material having a 2,5
c
impaired by wear and with specific elongation at break
MECHANICAL PROTECTIVE equal to or greater than 5 %
DEVICE (or primary system of
multiple support systems)
b
6 Support system parts Metallic material having a 4
c
impaired by wear and with specific elongation at break of
MECHANICAL PROTECTIVE less than 5 %
DEVICE (or primary system of
multiple support systems)
7 2,5
MECHANICAL PROTECTIVE
DEVICE (or back-up system
of multiple support system)
a
The TENSILE SAFETY FACTORS are intended to take account for conditions defined in 15.3.7
(IEC 60601-1:2005) (i.e. environmental effects, impairing effects of wear, corrosion, material
fatigue or ageing).
b
For non-metallic materials, particular standards can prescribe adequate TENSILE SAFETY FACTORS
(see rationale in Annex A, Subclause 9.8).
c
Components considered impaired by wear include: chains, cables (wire rope), belts, jack screw
nuts, springs, pneumatic or hydraulic hoses, gaskets or rings of pneumatic or hydraulic pistons.

201.9.8.3.2 Static forces due to loading from persons
Addition:
For DENTAL PATIENT CHAIRS the mass distribution of Table 201.103 shall be applied:

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Table 201.103 – Mass distribution
Part of DENTAL PATIENT CHAIR Mass-distribution
kg
Head and neck 10
Upper trunk and upper arms 45
Lower trunk, lower arms and
hands, thighs
Legs and feet 25
Total 135
Masses greater than 135 kg shall be distributed proportionally according to the values in
Table 201.103.
Position the DENTAL PATIENT CHAIR in the most unfavourable position according to
MANUFACTURER´S information.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:
201.10.4 Lasers and light-emitting diodes (LED)
Replacement:
For lasers the relevant requirements of IEC 60825-1 or IEC 60601-2-22 apply.
For light-emitting diodes (LEDs) the relevant requirements of IEC 60601-2-57 or IEC 62471
apply.
Compliance is checked by following the relevant PROCEDURES of IEC 60825-1, IEC 62471
IEC 60601-2-22 and IEC 60601-2-57.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.1 * Maximum temperature during NORMAL USE
Amendment:
Table 201.104 replaces Table 23 for allowable maximum temperatures for DENTAL
HANDPIECES:
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Table 201.104 – Allowable maximum temperatures for DENTAL HANDPIECES
Part Allowable maximum Condition
Temperature IEC 60601-1:2005
°C
Metal Glass, Moulded
and porcelain, material
liquids vitreous plastic,
material rubber,
wood
a
OPERATOR SIDE OF DENTAL HANDPIECE 56 66 71 NC

a
OPERATOR SIDE OF DENTAL HANDPIECE 56 66 71 SFC
OPERATOR SIDE OF DENTAL HANDPIECE 65 80 80 Reasonably
foreseeable
misuse
a
Row 2 of Table 23 of IEC 60601-1:2005 was selected, based on the reaction time of the
OPERATOR
For environmental temperature see 201.5.3.
The maximum rate of temperature rise shall not exceed 5 °C/1 s on the OPERATOR SIDE OF
DENTAL HANDPIECES in NORMAL CONDITIONs and SINGLE FAULT CONDITIONs.
201.11.1.2.2 *APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
For PATIENT SIDE OF DENTAL HANDPIECES in NORMAL and SINGLE FAULT CONDITION the limits of
Table 24 of IEC 60601-1:2005 shall apply. If the surface temperature of an APPLIED PART
exceeds 43 °C, the maximum temperature shall be disclosed in the instructions for use and
the clinical effects with respect to characteristics such as body surface, maturity of PATIENTS,
medications being taken or surface pressure shall be determined and documented in the RISK
MANAGEMENT FILE. Where 43 °C is not exceeded, no justification is required.
Additional subclause:
201.11.1.2.2.101 Multifunctional air and water DENTAL HANDPIECE
For multifunctional air and water DENTAL HANDPIECES the temperature of the water and/or air
shall not cause a HAZARD to the PATIENT and OPERATOR.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
201.11.1.3 * Measurements
Addition:
aa) DENTAL ELECTRICAL MOTOR
1) Measurement under following conditions
Fix the DENTAL ELECTRICAL MOTOR  in its normal position, without additional external air
cooling .
Power supply: The DENTAL ELECTRICAL MOTOR shall be powered by the MANUFACTURER'S
motor control circuit.
NOTE 101 The power supply and motor control circuit are often specific for the DENTAL ELECTRICAL
MOTOR.
Compliance is checked by:
– Measurement (idle running)
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Operating condition:
• with cooling air (according to MANUFACTURER´S instructions for use);
• without spray-air;
• without spray-water;
• light on if applicable.
Operate the DENTAL ELECTRICAL MOTOR
...