EN IEC 80601-2-60:2020

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

IEC 80601-2-60:2019 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. IEC 80601-2-60:2019 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.

Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Dental-Geräten

Appareils électromédicaux - Partie 2-60: Exigences particulères pour la sécurité de base et les performances essentielles des équipements dentaires

IEC 80601-2-60:2019 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des UNITES DENTAIRES, des FAUTEUILS DENTAIRES PATIENT, des PIECES A MAIN DENTAIRES et des SCIALYTIQUES, désignés ci-après sous le terme EQUIPEMENTS DENTAIRES. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si ce n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d’application du présent document ne sont pas couverts par des exigences spécifiques du présent document, à l’exception de 7.2.13 et de 8.4.1 de la norme générale. IEC 80601-2-60:2019 annule et remplace la première édition parue en 2012. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) alignement sur l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD1:2012.

Medicinska električna oprema - 2-60. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zobozdravstvene opreme (IEC 80601-2-60:2019)

General Information

• Status: Published
• Publication Date: 02-Apr-2020
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 03-Apr-2020
• Completion Date: 03-Apr-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN IEC 80601-2-60:2020 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (IEC 80601-2-60:2019)

Relations

• Replaces: EN 80601-2-60:2015 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
• Effective Date: 12-Jan-2016

Standards Content (Sample)

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 d
...