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

IEC 80601-2-60:2012 applies to the basic safety and essential performance of Dental Units, Dental Patient Chairs, Dental Handpieces and Dental Operating Lights. Excluded are amalgamators, sterilizers and dental X-ray equipment.

Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen für 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

La CEI 80601-2-60:2012 s'applique à la sécurité de base et aux performances essentielles des Unités Dentaires, des Fauteuils Dentaires pour patient, des Outils à Main Dentaires et des Scialytiques. En sont exclus les vibreurs d'amalgame, les stérilisateurs et les équipements dentaires à rayonnement X.

Medicinska električna oprema - 2-60. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zobozdravstvene opreme

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI DENTALNIH ENOT, STOLOV ZA DENTALNE PACIENTE, DENTALNIH ROČNIH PRIPOMOČKOV IN DENTALNE OPERACIJSKE RAZSVETLJAVE, v nadaljevanju: ZOBOZDRAVSTVENA OPREMA. Izključeni so mešalni aparati, sterilizatorji in zobozdravstvena rentgenska oprema. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Glej tudi točko 4.2 splošnega standarda.

General Information

Status
Published
Publication Date
21-May-2015
Current Stage
6060 - Document made available
Due Date
22-May-2015
Completion Date
22-May-2015

RELATIONS

Buy Standard

Standard
EN 80601-2-60:2015
English language
38 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN 80601-2-60:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]RER]GUDYVWYHQHRSUHPH

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
SIST EN 80601-2-60:2015 en

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

---------------------- Page: 1 ----------------------
SIST EN 80601-2-60:2015
---------------------- Page: 2 ----------------------
SIST EN 80601-2-60:2015
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
---------------------- Page: 3 ----------------------
SIST EN 80601-2-60:2015
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).
---------------------- Page: 4 ----------------------
SIST EN 80601-2-60:2015
EN 80601-2-60:2015 (E)
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 -
---------------------- Page: 5 ----------------------
SIST EN 80601-2-60:2015
EN 80601-2-60:2015 (E)
Publication Year Title EN/HD Year
ISO 7785-2 - Dental handpieces - EN ISO 7785-2 -
Part 2: Straight and geared angle handpieces
---------------------- Page: 6 ----------------------
SIST EN 80601-2-60:2015
EN 80601-2-60:2015 (E)
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.
---------------------- Page: 7 ----------------------
SIST EN 80601-2-60:2015
---------------------- Page: 8 ----------------------
SIST EN 80601-2-60:2015
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

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.

---------------------- Page: 9 ----------------------
SIST EN 80601-2-60:2015
– 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

---------------------- Page: 10 ----------------------
SIST EN 80601-2-60:2015
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 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: 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.

---------------------- Page: 11 ----------------------
SIST EN 80601-2-60:2015
– 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.
---------------------- Page: 12 ----------------------
SIST EN 80601-2-60:2015
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
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

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.
___________

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

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

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
---------------------- Page: 13 ----------------------
SIST EN 80601-2-60:2015
– 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:
---------------------- Page: 14 ----------------------
SIST EN 80601-2-60:2015
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
---------------------- Page: 15 ----------------------
SIST EN 80601-2-60:2015
– 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
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.