Household and similar electrical appliances - Safety - Part 2-113: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources (IEC 60335-2-113:2016)

This clause of Part 1 is replaced by the following.
This International Standard deals with the safety of cosmetic and beauty care appliances
incorporating lasers or intense light sources for household and similar purposes, where their
operation relies on contact with the skin, their rated voltage being not more than 250 V.
NOTE 101 Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard.
Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated appliances
when operated in the battery mode.
This standard covers appliances with a light emitting surface less than 25 cm 2 . Appliances
with a light emitting surface equal to or greater than 25 cm 2 are within the scope
of IEC 60335-2-27.
Appliances not intended for normal household use but which nevertheless may be a source of
danger to the public such as appliances intended to be used in beauty salons and similar
premises are also within the scope of this standard.
Appliances covered by the scope of this standard include but are not limited to:
– appliances for control of hair growth;
– appliances for skin and beauty care incorporating lasers or intense light sources (ILS).
NOTE 102 Appliances incorporating lasers or intense light sources (ILS) either heat up hair follicles or skin
tissue to produce thermal effects or to produce photo-biological effects from specific wavelengths.
As far as is practicable, this standard deals with the common hazards presented by
appliances that are encountered by all persons in and around the home. However, in general,
it does not take into account:
– persons (including children) whose physical, sensory or mental capabilities or lack of
experience and knowledge prevents them from using the appliance safely without
supervision or instruction;
– children playing with the appliance.
NOTE 103 Attention is drawn to the fact that in many countries additional requirements are specified by the
national health authorities.
NOTE 104 This standard does not apply to
– appliances for medical purposes (IEC 60601);
– appliances for skin or hair care (IEC 60335-2-23);
– appliances for nail hardening;
– appliances for skin exposure to optical radiation with a light emitting surface equal to or greater than 25 cm 2
(IEC 60335-2-27).

Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-113: Besondere Anforderungen für Kosmetik- und Schönheitspflegegeräte mit eingebauten Lasern und Intensivlichtquellen (IEC 60335-2-113:2016)

Appareils électrodomestiques et analogues - Sécurité - Partie 2-113: Exigences particulières pour les appareils destinés aux soins cosmétiques et esthétiaues comportant des lasers et des sources de lumière de forte intensité (IEC 60335-2-113:2016)

IEC 60335-2-113:2016 traite de la sécurité des appareils de soins cosmétiques et esthétiques comportant des lasers ou des sources de lumière de forte intensité pour usages domestiques et analogues, dont le fonctionnement dépend du contact avec la peau et dont la tension assignée n'est pas supérieure à 250 V. NOTE 101 - Les appareils alimentés par batteries et les autres appareils alimentés en courant continu sont compris dans le domaine d'application de la présente norme. Les appareils à double alimentation, alimentés soit par le réseau soit par batteries, sont considérés comme des appareils alimentés par batteries lorsqu'ils fonctionnent en mode batterie. La présente norme couvre les appareils dont la surface électroluminescente est inférieure à 25 cm2. Les appareils dont la surface électroluminescente est supérieure ou égale à 25 cm2 relèvent du domaine d'application de l'IEC 60335-2-27. Les appareils non destinés à un usage domestique normal, mais qui néanmoins peuvent constituer une source de danger pour le public, tels que les appareils destinés à être utilisés dans des salons de beauté et des locaux analogues relèvent également du domaine d'application de la présente norme. Les appareils couverts par le domaine d'application de la présente norme incluent, sans toutefois s'y limiter:
- les appareils pour le contrôle de la pousse des cheveux et
- les appareils pour les soins de la peau et les soins esthétiques comportant des lasers ou des sources de lumière de forte intensité (ILS, intense light source). Les appareils comportant des lasers ou des sources de lumière de forte intensité (ILS) chauffent les follicules capillaires ou les tissus cutanés afin de produire des effets thermiques ou des effets photobiologiques à partir de longueurs d'ondes spécifiques. Dans la mesure du possible, la présente norme traite des dangers ordinaires présentés par les appareils, encourus par tous les individus à l'intérieur et autour de l'habitation. Cependant, la présente norme ne tient généralement pas compte:
- des personnes (y compris des enfants) dont les capacités physiques, sensorielles ou mentales ou le manque d'expérience et de connaissance les empêchent d'utiliser l'appareil en toute sécurité sans surveillance ou instruction
- ou de l'utilisation de l'appareil comme jouet par des enfants.
L'attention des Comités nationaux est attirée sur le fait que les fabricants d'appareils et les organismes d'essai peuvent avoir besoin d'une période transitoire après la publication d'une nouvelle publication IEC, ou d'une publication amendée ou révisée, pour fabriquer des produits conformes aux nouvelles exigences et pour adapter leurs équipements aux nouveaux essais ou aux essais révisés.
Le comité recommande que le contenu de la présente norme soit entériné au niveau national au plus tôt 12 mois ou au plus tard 36 mois après la date de publication.
Mots clés: cosmétiques, soins esthétiques, lasers, sources de lumière de forte intensité
Cette publication doit être lue conjointement avec la IEC 60335-1:2010.

Gospodinjski in podobni električni aparati - Varnost - 2-113. del: Posebne zahteve za kozmetične in lepotne aparate z laserji in viri močne svetlobe (IEC 60335-2-113:2016)

To točko 1. dela nadomešča naslednje besedilo.
Ta mednarodni standard obravnava varnost kozmetičnih in lepotnih aparatov z laserji ali viri močne svetlobe za gospodinjske in podobne namene z nazivno napetostjo največ 250 V, pri uporabi katerih prihaja do stika s kožo.
OPOMBA 101: Baterijski aparati in drugi aparati z enosmernim napajanjem spadajo na področje uporabe tega standarda.
Aparati z dvojnim napajanjem (prek omrežja ali akumulatorja) se štejejo za baterijske aparate, če delujejo v baterijskem načinu.
Ta standard zajema aparate s svetlobno površino, manjšo od 25 cm2. Aparati s svetlobno površino 25 cm2 ali večjo spadajo na področje uporabe standarda IEC 60335-2-27.
Področje uporabe tega standarda zajema tudi aparate, ki niso namenjeni za običajno gospodinjsko uporabo, vendar so lahko vir nevarnosti za javnost, kot so aparati, ki se uporabljajo v kozmetičnih salonih in podobno.
Na področje uporabe tega standarda med drugim spadajo:
– aparati za nadzor rasti las;
– aparati za nego kože in lepotni aparati z laserji ali viri močne svetlobe (ILS).
OPOMBA 102: Aparati z laserji ali viri močne svetlobe segrejejo lasne mešičke ali kožno tkivo in s tem ustvarijo toplotne učinke ali foto-biološke učinke zaradi delovanja določenih valovnih dolžin.
Ta standard v največji možni meri obravnava splošne nevarnosti, ki jih predstavljajo aparati ter s katerimi se srečujejo osebe doma in v okolici doma. Vendar na splošno ne vključuje primerov:
– oseb (tudi otrok), ki zaradi fizičnih, senzoričnih ali umskih sposobnosti oziroma pomanjkanja izkušenj in znanja ne morejo varno uporabljati aparata brez nadzora ali navodil;
– otrok, ki se igrajo z aparatom.
OPOMBA 103: Opozoriti je treba, da v številnih državah nacionalni zdravstveni organi določajo dodatne zahteve.
OPOMBA 104: Ta standard se ne uporablja za:
– aparate za medicinsko uporabo (IEC 60601);
– aparate za nego kože ali las (IEC 60335-2-23);
– aparate za utrjevanje nohtov;
– aparate za nego kože z optičnim sevanjem s svetlobno površino 25 cm2 ali večjo.

General Information

Status
Published
Publication Date
31-May-2023
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
17-May-2023
Due Date
22-Jul-2023
Completion Date
01-Jun-2023

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SLOVENSKI STANDARD
SIST EN IEC 60335-2-113:2023
01-julij-2023
Gospodinjski in podobni električni aparati - Varnost - 2-113. del: Posebne zahteve
za kozmetične in lepotne aparate z laserji in viri močne svetlobe (IEC 60335-2-
113:2016)
Household and similar electrical appliances - Safety - Part 2-113: Particular requirements
for cosmetic and beauty care appliances incorporating lasers and intense light sources
(IEC 60335-2-113:2016)
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-113:
Besondere Anforderungen für Kosmetik- und Schönheitspflegegeräte mit eingebauten
Lasern und Intensivlichtquellen (IEC 60335-2-113:2016)
Appareils électrodomestiques et analogues - Sécurité - Partie 2-113: Exigences
particulières pour les appareils destinés aux soins cosmétiques et esthétiaues
comportant des lasers et des sources de lumière de forte intensité (IEC 60335-2-
113:2016)
Ta slovenski standard je istoveten z: EN IEC 60335-2-113:2023
ICS:
13.120 Varnost na domu Domestic safety
97.170 Oprema za nego telesa Body care equipment
SIST EN IEC 60335-2-113:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60335-2-113:2023

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SIST EN IEC 60335-2-113:2023


EUROPEAN STANDARD EN IEC 60335-2-113

NORME EUROPÉENNE

EUROPÄISCHE NORM May 2023
ICS 13.120; 97.170

English Version
Household and similar electrical appliances - Safety - Part 2-113:
Particular requirements for cosmetic and beauty care appliances
incorporating lasers and intense light sources
(IEC 60335-2-113:2016)
Appareils électrodomestiques et analogues - Sécurité - Sicherheit elektrischer Geräte für den Hausgebrauch und
Partie 2-113: Exigences particulières pour les appareils ähnliche Zwecke - Teil 2-113: Besondere Anforderungen für
destinés aux soins cosmétiques et esthétiaues comportant Kosmetik- und Schönheitspflegegeräte mit eingebauten
des lasers et des sources de lumière de forte intensité Lasern und Intensivlichtquellen
(IEC 60335-2-113:2016) (IEC 60335-2-113:2016)
This European Standard was approved by CENELEC on 2023-03-01. 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,
Türkiye 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
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60335-2-113:2023 E

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SIST EN IEC 60335-2-113:2023
EN IEC 60335-2-113:2023 (E)
European foreword
This document (EN IEC 60335-2-113:2023) consists of the text of document IEC 60335-2-113:2016, prepared
by IEC/TC 61 “Safety of household and similar electrical appliances”.
The following dates are fixed:
• latest date by which this document has to be (dop) 2024-03-01
implemented at national level by publication of an
identical national standard or by endorsement
• latest date by which the national standards (dow) 2026-03-01
conflicting with this 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 shall not be held responsible for identifying any or all such patent rights.
This document is read in conjunction with EN IEC 60335-2-113:2023/A11:2023.
Any feedback and questions on this document should be directed to the users’ national committee. A complete
listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60335-2-113:2016 was approved by CENELEC as a European
Standard without any modification.


2

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SIST EN IEC 60335-2-113:2023




IEC 60335-2-113

®


Edition 1.0 2016-04




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










Household and similar electrical appliances – Safety –

Part 2-113: Particular requirements for cosmetic and beauty care appliances

incorporating lasers and intense light sources




Appareils électrodomestiques et analogues – Sécurité –

Partie 2-113: Exigences particulières pour les appareils destinés aux soins


cosmétiques et esthétiques comportant des lasers et des sources de lumière

de forte intensité












INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 13.120; 97.170 ISBN 978-2-8322-3309-2



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.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN IEC 60335-2-113:2023
– 2 – IEC 60335-2-113:2016 © IEC 2016

CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references. 7
3 Terms and definitions . 7
4 General requirement . 8
5 General conditions for the tests . 8
6 Classification . 9
7 Marking and instructions . 9
8 Protection against access to live parts . 11
9 Starting of motor-operated appliances . 11
10 Power input and current . 11
11 Heating . 11
12 Void . 12
13 Leakage current and electric strength at operating temperature . 12
14 Transient overvoltages. 12
15 Moisture resistance . 12
16 Leakage current and electric strength . 12
17 Overload protection of transformers and associated circuits . 12
18 Endurance . 12
19 Abnormal operation . 12
20 Stability and mechanical hazards . 12
21 Mechanical strength . 12
22 Construction . 13
23 Internal wiring . 17
24 Components . 17
25 Supply connection and external flexible cords . 17
26 Terminals for external conductors . 18
27 Provision for earthing . 18
28 Screws and connections . 18
29 Clearances, creepage distances and solid insulation . 18
30 Resistance to heat and fire . 18
31 Resistance to rusting . 19
32 Radiation, toxicity and similar hazards . 19
Annexes . 20
Annex R (normative) Software evaluation . 20
Bibliography . 21

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SIST EN IEC 60335-2-113:2023
IEC 60335-2-113:2016 © IEC 2016 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________

HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES –
SAFETY –

Part 2-113: Particular requirements for cosmetic and beauty care
appliances incorporating lasers and intense light sources

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.
This part of International Standard IEC 60335 has been prepared by IEC technical committee
61: Safety of household and similar electrical appliances.
The text of this standard is based on the following documents:
FDIS Report on voting
61/5112/FDIS 61/5132/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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– 4 – IEC 60335-2-113:2016 © IEC 2016
This part 2 is to be used in conjunction with the latest edition of IEC 60335-1 and its
amendments. It was established on the basis of the fifth edition (2010) of that standard.
NOTE 1 When “Part 1” is mentioned in this standard, it refers to IEC 60335-1.
This part 2 supplements or modifies the corresponding clauses in IEC 60335-1, so as to
convert that publication into the IEC standard: Safety requirements for cosmetic and beauty
care appliances incorporating lasers and intense light sources.
When a particular subclause of Part 1 is not mentioned in this part 2, that subclause applies
as far as is reasonable. When this standard states “addition”, “modification” or “replacement”,
the relevant text in Part 1 is to be adapted accordingly.
NOTE 2 The following numbering system is used:
– subclauses, tables and figures that are numbered starting from 101 are additional to those in Part 1;
– unless notes are in a new subclause or involve notes in Part 1, they are numbered starting from 101, including
those in a replaced clause or subclause;
– additional annexes are lettered AA, BB, etc.
NOTE 3 The following print types are used:
– requirements: in roman type;
– test specifications: in italic type;
– notes: in small roman type.
Words in bold in the text are defined in Clause 3. When a definition concerns an adjective, the adjective and the
associated noun are also in bold.
A list of all parts of the IEC 60335 series, under the general title: Household and similar
electrical appliances – Safety, 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.

NOTE 4 The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests.
It is the recommendation of the committee that the content of this standard be adopted for implementation
nationally not earlier than 12 months or later than 36 months from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.

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SIST EN IEC 60335-2-113:2023
IEC 60335-2-113:2016 © IEC 2016 – 5 –
INTRODUCTION
It has been assumed in the drafting of this International Standard that the execution of its
provisions is entrusted to appropriately qualified and experienced persons.
This standard recognizes the internationally accepted level of protection against hazards such
as electrical, mechanical, thermal, fire and radiation of appliances when operated as in
normal use taking into account the manufacturer's instructions. It also covers abnormal
situations that can be expected in practice and takes into account the way in which
electromagnetic phenomena can affect the safe operation of appliances.
This standard takes into account the requirements of IEC 60364 as far as possible so that
there is compatibility with the wiring rules when the appliance is connected to the supply
mains. However, national wiring rules may differ.
If an appliance within the scope of this standard also incorporates functions that are covered
by another part 2 of IEC 60335, the relevant part 2 is applied to each function separately, as
far as is reasonable. If applicable, the influence of one function on the other is taken into
account.
When a part 2 standard does not include additional requirements to cover hazards dealt with
in Part 1, Part 1 applies.
NOTE 1 This means that the technical committees responsible for the part 2 standards have determined that it is
not necessary to specify particular requirements for the appliance in question over and above the general
requirements.
This standard is a product family standard dealing with the safety of appliances and takes
precedence over horizontal and generic standards covering the same subject.
NOTE 2 Horizontal and generic standards covering a hazard are not applicable since they have been taken into
consideration when developing the general and particular requirements for the IEC 60335 series of standards. For
example, in the case of temperature requirements for surfaces on many appliances, generic standards, such as
ISO 13732-1 for hot surfaces, are not applicable in addition to Part 1 or this part 2 standard. This does not apply to
IEC 60825-1, except where specified in this part 2 standard.
An appliance that complies with the text of this standard will not necessarily be considered to
comply with the safety principles of the standard if, when examined and tested, it is found to
have other features that impair the level of safety covered by these requirements.
An appliance employing materials or having forms of construction differing from those detailed
in the requirements of this standard may be examined and tested according to the intent of
the requirements and, if found to be substantially equivalent, may be considered to comply
with the standard.

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– 6 – IEC 60335-2-113:2016 © IEC 2016
HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES –
SAFETY –

Part 2-113: Particular requirements for cosmetic and beauty care
appliances incorporating lasers and intense light sources



1 Scope
This clause of Part 1 is replaced by the following.
This International Standard deals with the safety of cosmetic and beauty care appliances
incorporating lasers or intense light sources for household and similar purposes, where their
operation relies on contact with the skin, their rated voltage being not more than 250 V.
NOTE 101 Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard.
Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated appliances
when operated in the battery mode.
2
This standard covers appliances with a light emitting surface less than 25 cm . Appliances
2
with a light emitting surface equal to or greater than 25 cm are within the scope
of IEC 60335-2-27.
Appliances not intended for normal household use but which nevertheless may be a source of
danger to the public such as appliances intended to be used in beauty salons and similar
premises are also within the scope of this standard.
Appliances covered by the scope of this standard include but are not limited to:
– appliances for control of hair growth;
– appliances for skin and beauty care incorporating lasers or intense light sources (ILS).
NOTE 102 Appliances incorporating lasers or intense light sources (ILS) either heat up hair follicles or skin
tissue to produce thermal effects or to produce photo-biological effects from specific wavelengths.
As far as is practicable, this standard deals with the common hazards presented by
appliances that are encountered by all persons in and around the home. However, in general,
it does not take into account:
– persons (including children) whose physical, sensory or mental capabilities or lack of
experience and knowledge prevents them from using the appliance safely without
supervision or instruction;
– children playing with the appliance.
NOTE 103 Attention is drawn to the fact that in many countries additional requirements are specified by the
national health authorities.
NOTE 104 This standard does not apply to
– appliances for medical purposes (IEC 60601);
– appliances for skin or hair care (IEC 60335-2-23);
– appliances for nail hardening;
2
– appliances for skin exposure to optical radiation with a light emitting surface equal to or greater than 25 cm
(IEC 60335-2-27).

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SIST EN IEC 60335-2-113:2023
IEC 60335-2-113:2016 © IEC 2016 – 7 –
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and
requirements
IEC 62471:2006, Photobiological safety of lamps and lamp systems
ISO 7010, Graphical symbols – Safety colours and safety signs – Registered safety signs
ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical
practice
3 Terms and definitions
This clause of Part 1 is applicable except as follows.
Addition:
Additional terms and definitions given in IEC 60825-1 and IEC 62471 are also applicable.
3.1.9 Replacement:
normal operation
use of the appliance applied in accordance with the manufacturer’s instructions
3.101
accessible emission limit
AEL
maximum accessible emission permitted within a particular class of laser product or ILS risk
group
Note 1 to entry: Accessible emission limit is hereinafter referred to as AEL.
Note 2 to entry: Wherever the text refers to “emission level not exceeding the AEL” or similar wording, it is
implicit that the accessible emission is determined following the measurement criteria specified in Clause 5 of
IEC 60825-1:2014 or Clause 5 of IEC 62471:2006.
3.102
Class 1C laser product
laser product that during operation does not permit stray optical radiation in excess of the
AEL of Class 1 for applicable wavelengths and emission durations
3.103
embedded laser
laser that emits radiation within the AEL of Class 3R laser products, Class 3B laser
products or Class 4 laser products, and that is incorporated in an appliance classified in a
lower class
3.104
good contact
state that is established when the applicator is positioned at the target skin so that the skin
acts to effectively prevent stray optical radiation exposure in excess of the ocular MPE
Note 1 to entry: Hazardous radiation emission refers to levels in excess of the ocular MPE.

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3.105
intense light source
source of intense broadband non-laser light which emits optical radiation exceeding that of
the exempt group, and that is intended to cause a thermal or photo-chemical effect to the
target tissue
Note 1 to entry: Intense light sources are hereinafter referred to as ILS.
Note 2 to entry: ILS may incorporate continuously emitting or pulsed xenon light bulbs, incandescent bulbs, LEDs
or similar.
3.106
risk group
lamp classification according to IEC 62471
3.107
stray optical radiation
optical energy that is unintentionally emitted from the applicator, including scattered, reflected,
and leakage radiation
3.108
maximum permissible exposure
level of optical radiation to which, under normal circumstances, persons may be exposed
without suffering adverse effects
Note 1 to entry: Maximum permissible exposure is hereinafter referred to as MPE.
3.109
swivel connection
means for connecting the supply cord so that the appliance can be rotated continuously
without twisting the cord
4 General requirement
This clause of Part 1 is applicable.
5 General conditions for the tests
This clause of Part 1 is applicable except as follows.
5.2 Addition:
The additional test of 25.14 for hand-held appliances is carried out on a separate appliance.
5.101 Beauty care appliances are tested as a motor-operated appliance.
5.102 Where a test specification requires testing on skin or artificial skin, the artificial skin
shall be similar in softness, heat capacity and reflection conditions of human skin.
NOTE Suitable material for the artificial skin is silicone rubber with a thickness of 10 mm [e.g., (Wacker Chemie
AG Elastosil RT 604, A/B) mix ratio = 9:1 with 0,6 % colour (Max Factor Creme Puff Compact Powder – 41 Medium
1
Beige) and 6 % scattering material (Sigma Aldrich Chemical Co. AL203)] .
______________
1
 This information is given for the convenience of users of this document and does not constitute an endorsement
by IEC of these products.

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IEC 60335-2-113:2016 © IEC 2016 – 9 –
For appliances with interlock system using a capacitive detection, the artificial skin shall also
be similar in dielectric constant condition of human skin.
6 Classification
This clause of Part 1 is applicable.
7 Marking and instructions
This clause of Part 1 is applicable except as follows.
7.1 Addition:
Appliances shall also be marked with the following, if applicable:
– a warning that intense visible and invisible optical radiation emitted from the device may
cause eye injury;
– indication to avoid eye exposure;
– symbol ISO 7000-1329 (2004-01), for Class 1C laser product appliances;
– symbol ISO 7010-W027 (2011-05), for appliances incorporating an ILS;
– symbol ISO 7000-0790 (2004-01) to indicate the need to consult the user manual.
7.6 Addition:
[symbol ISO 7000-1329 (2004-01)] laser beam


[symbol ISO 7010-W027 (2011-05)] Warning; Optical radiation


7.12 Addition:
The instructions shall include the substance of the following warnings, if applicable:
WARNING. Possible eye injury (potentially leading to loss of vision) or skin injury if
instructions are not followed. Read and follow the instructions.
WARNING. Only use disposable and consumable materials recommended by the
manufacturer.
WARNING. Damage of the skin may occur after prolonged or repeated surface application
on one site.
WARNING. Misuse can lead to eye damage. Protect the eye from exposure. Do not use
the appliance over the eye lids or close to the eye.
WARNING. Do not override the safety mechanisms inherent to the device.
WARNING. If taking a photosensitizing medication or herbal remedy, seek medical advice
prior to application of the appliance as use may harm the skin.

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The instructions shall include the substance of the following, if applicable:
– do not use the appliance in areas where skin integrity has been impaired (for example, in
the presence of burns, lesions, blisters, scars, cuts, open wounds, active skin disease,
recent sun tan or sun burn, a
...

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