Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (IEC 80601-2-60:2019)

EN-IEC 80601-2-60 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.

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)

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
27-Apr-2020
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Apr-2020
Due Date
27-Jun-2020
Completion Date
28-Apr-2020

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SLOVENSKI STANDARD
SIST EN IEC 80601-2-60:2020
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
SIST EN IEC 80601-2-60:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 80601-2-60:2020
---------------------- Page: 2 ----------------------
SIST EN IEC 80601-2-60:2020
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
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SIST EN IEC 80601-2-60:2020
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)
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SIST EN IEC 80601-2-60:2020
EN IEC 80601-2-60:2020 (E)
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
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SIST EN IEC 80601-2-60:2020
EN IEC 80601-2-60:2020 (E)
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
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SIST EN IEC 80601-2-60:2020
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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SIST EN IEC 80601-2-60:2020
– 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

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SIST EN IEC 80601-2-60:2020
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.
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SIST EN IEC 80601-2-60:2020
– 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.
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SIST EN IEC 80601-2-60:2020
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.
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SIST EN IEC 80601-2-60:2020
– 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.
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SIST EN IEC 80601-2-60:2020
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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SIST EN IEC 80601-2-60:2020
– 8 – IEC 80601-2-60:2019 © IEC 2019
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
---------------------- Page: 14 ----------------------
SIST EN IEC 80601-2-60:2020
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 w
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