EN 80601-2-60:2015

SLOVENSKI STANDARD
01-september-2015
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Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and
essential performance of dental equipment
Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen an die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Dental-Geräten
Appareils électromédicaux - Partie 2-60: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements dentaires
Ta slovenski standard je istoveten z: EN 80601-2-60:2015
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 80601-2-60

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.01
English Version
Medical electrical equipment - Part 2-60: Particular requirements
for the basic safety and essential performance of dental
equipment
(IEC 80601-2-60:2012)
Appareils électromédicaux - Partie 2-60: Exigences Medizinische elektrische Geräte -- Teil 2-60: Besondere
particulières pour la sécurité de base et les performances Festlegungen an die Sicherheit einschließlich der
essentielles des équipements dentaires wesentlichen Leistungsmerkmale von Dental-Geräten
(IEC 80601-2-60:2012) (IEC 80601-2-60:2012)
This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 80601-2-60:2015 E
Foreword
The text of document 62D/964/FDIS, future edition 1 of IEC 80601-2-60, prepared by SC 62D,
"Electromedical equipment", of IEC/TC 62, "Electrical equipment in medical practice" and SC 6 "Dental
equipment" of ISO/TC 106 "Dentistry" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 80601-2-60:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 80601-2-60:2012 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 61810-7:2006 NOTE  Harmonized as EN 61810-7:2006 (not modified).
ISO 13732-1:2006 NOTE  Harmonized as EN ISO 13732-1:2008 (not modified).
ISO 17664:2004 NOTE  Harmonized as EN ISO 17664:2004 (not modified).
ISO 7494-2:2003 NOTE  Harmonized as EN ISO 7494-2:2003 (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, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies with the following exceptions:

Publication Year Title EN/HD Year

Replacement:
IEC 60664-1 2007 Insulation coordination for equipment within EN 60664-1 2007
low-voltage systems -
Part 1: Principles, requirements and tests

IEC 60825-1 - Safety of laser products - EN 60825-1 -
Part 1: Equipment classification and
requirements
Addition:
IEC 60601-2-2 2009 Medical electrical equipment - EN 60601-2-2 2009
Part 2-2: Particular requirements for basic + A11 2011
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,
therapeutic and diagnostic laser equipment

IEC 60601-2-57 2011 Medical electrical equipment - EN 60601-2-57 2011
Part 2-57: Particular requirements for 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 EN 60664-4 2006
low-voltage systems - + corr. October 2006
Part 4: Consideration of high-frequency
voltage stress
IEC 61180-1 - High-voltage test techniques for low-voltage EN 61180-1 -
equipment -
Part 1: Definitions, test and procedure
requirements
IEC 61180-2 - High-voltage test techniques for low-voltage EN 61180-2 -
equipment -
Part 2: Test equipment
IEC 61810-1 2008 Electromechanical elementary relays - EN 61810-1 2008
+ corr. February 2010 Part 1: General requirements

IEC 62471 - Photobiological safety of lamps and lamp EN 62471 -
systems
ISO 1942 - Dentistry - Vocabulary EN ISO 1942 -

Publication Year Title EN/HD Year

ISO 7785-2 - Dental handpieces - EN ISO 7785-2 -
Part 2: Straight and geared angle handpieces

Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
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,
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 acc
...