SIST EN IEC 60335-2-115:2023
(Main)Household and similar electrical appliances - Safety - Part 2-115: Particular requirements for skin beauty care appliances (IEC 60335-2-115:2021 + COR1:2022)
Household and similar electrical appliances - Safety - Part 2-115: Particular requirements for skin beauty care appliances (IEC 60335-2-115:2021 + COR1:2022)
This clause of Part 1 is replaced by the following.
This part of IEC 60335 deals with the safety of electric appliances for skin beauty care of
persons and intended for household, commercial and similar purposes, their rated voltage
being not more than 250 V.
NOTE 101 Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated
appliances when operated in the battery mode.
Examples of appliances that are within the scope of this standard are
• battery-operated appliances and other DC supplied appliances for skin beauty care;
• appliances with high frequency outputs including equipment for heat-producing effects on
the skin;
• appliances with medium frequency outputs including interferential outputs, for skin
stimulation or muscle stimulation;
• appliances with low frequency outputs (e.g. faradic currents) for application such as skin
stimulation or muscle stimulation;
• appliances with extra-low voltage DC outputs (e.g. galvanic currents), such as electro-
epilation (hair removal);
• skin beauty care appliances with ultrasonic outputs;
• appliances having vacuum-pressure functions;
• skin beauty care appliances for melting wax;
• appliances intended to produce surface cooling effect on the skin;
• facial cleaning appliances;
• micro-needling appliances;
• plasma pens.
NOTE 102 Appliances covered by this standard can incorporate vapour-producing devices or spray-producing
devices.
This standard deals with the common hazards presented by appliances that are encountered
by all persons. 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
– it is recognized that persons having very extensive and complex disabilities can have needs beyond the level
addressed in this standard.
– for appliances intended to be used in vehicles or on board ships or aircraft, additional requirements can be
necessary;
– in many countries, additional requirements can be specified by the national health authorities, the national
authorities responsible for the protection of labour and similar authorities.
This standard does not apply to
– appliances intended exclusively for industrial purposes;
– appliances intended to be used in locations where special conditions prevail, such as the
presence of a corrosive or explosive atmosphere (dust, vapour or gas);
– shavers, hair clippers and similar appliances (IEC 60335-2-8);
– blankets, pads, clothing and similar flexible heating appliances (IEC 60335-2-17);
– appliances for skin or hair care such as facial saunas, hand dryers, foot care appliances
(IEC 60335-2-23);
– spray tanning appliances;
– appliances for skin exposure to optical radiation (IEC 60335-2-27);
– sauna heating appliances and infrared cabins (IEC 60335-2-53);
– cosmetic and beauty care appliances incorporating lasers and intense light sources
– appliances intended for medical purposes (IEC 60601);
– radio frequency appliances without contact to the skin;
– ultrasound appliances provided with focusing ultrasound transducers.
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-115: Besondere Anforderungen für Schönheitspflegegeräte (IEC 60335-2-115:2021 + COR1:2022)
Appareils électrodomestiques et analogues - Sécurité - Partie 2-115: Exigences particulières pour les appareils destinés aux soins esthétiques de la peau (IEC 60335-2-115:2021 + COR1:2022)
L'IEC 60335-2-115:2021 traite de la sécurité des appareils électriques destinés aux soins esthétiques de la peau des personnes pour usages domestiques, commerciaux et analogues et dont la tension assignée ne dépasse pas 250 V.
Les appareils à double alimentation, alimentés soit par le réseau soit par des batteries, sont considérés comme des appareils alimentés par batteries lorsqu'ils fonctionnent en mode batterie.
La liste suivante répertorie les exemples d'appareils qui relèvent du domaine d'application de la présente norme
- les appareils alimentés par batteries et autres appareils alimentés en courant continu destinés aux soins esthétiques de la peau;
- les appareils à haute fréquence, y compris les équipements qui produisent de la chaleur sur la peau;
- les appareils à moyenne fréquence, y compris les débits de sortie d'interférences, destinés à la stimulation cutanée ou musculaire;
- les appareils à basse fréquence (par exemple, courants faradiques) destinés à des applications telles que la stimulation cutanée ou musculaire;
- les appareils en courant continu à très basse tension (par exemple, courants galvaniques) tels que les épilateurs électriques;
- les appareils à ultrasons destinés aux soins esthétiques de la peau;
- les appareils qui comportent des fonctions de dépression;
- les appareils à la cire chaude destinés aux soins esthétiques de la peau (appareils à cire chauffée);
- les appareils destinés à produire un effet froid sur la peau;
- les appareils de nettoyage du visage;
- les appareils à microaiguilles;
- les stylos plasma.
Les appareils couverts par la présente norme peuvent intégrer des dispositifs qui produisent de la vapeur ou des pulvérisateurs.
La présente norme traite des dangers courants que présentent les appareils et auxquels sont confrontés tous les individus. Cependant, la présente norme ne tient pas compte en général des personnes (y compris des enfants) dont
- les capacités physiques, sensorielles ou mentales; ou
- le manque d'expérience et de connaissances
les empêchent d'utiliser l'appareil en toute sécurité sans surveillance ou instruction;
- de l'utilisation de l'appareil comme jouet par des enfants.
L'attention est attirée sur le fait que:
– il est avéré que les personnes dont les incapacités sont très étendues et complexes peuvent avoir des besoins qui dépassent le niveau traité dans la présente norme;
– pour les appareils destinés à être utilisés dans des véhicules ou à bord de navires ou d'avions, des exigences supplémentaires peuvent être nécessaires;
– dans de nombreux pays, des exigences supplémentaires peuvent être spécifiées par les autorités sanitaires nationales, les organismes nationaux en charge de la protection des travailleurs et les organismes analogues.
La présente norme ne s'applique pas
- aux appareils prévus exclusivement pour des usages industriels;
- aux appareils destinés à être utilisés dans des locaux présentant des conditions particulières, telles que la présence d'une atmosphère corrosive ou explosive (poussière, vapeur ou gaz);
- aux rasoirs, tondeuses et appareils analogues (IEC 60335-2-8);
- aux couvertures, coussins, vêtements et appareils chauffants souples analogues (IEC 60335-2-17);
- aux appareils destinés aux soins de la peau ou des cheveux, tels que les appareils de sauna facial, les sèche-mains, les
Gospodinjski in podobni električni aparati - Varnost - 2-115. del: Posebne zahteve za aparate za nego kože (IEC 60335-2-115:2021 + COR1:2022)
To točko 1. dela nadomešča naslednje besedilo.
Ta del standarda IEC 60335 obravnava varnost električnih aparatov za nego kože oseb, ki so namenjeni za gospodinjsko, komercialno in podobno uporabo, katerih nazivna napetost ne presega 250 V.
OPOMBA 101: Aparati z dvojnim napajanjem (prek omrežja ali baterije) se štejejo za baterijske aparate, če delujejo v baterijskem načinu.
Primeri aparatov, ki spadajo na področje uporabe tega standarda:
• baterijski aparati in drugi aparati z enosmernim napajanjem za nego kože;
• aparati z visoko frekvenčno izhodno močjo, vključno z opremo za ustvarjanje toplotnih učinkov na koži;
• aparati s srednjo frekvenčno izhodno močjo, vključno z interferenčno izhodno močjo za stimulacijo kože ali mišic;
• aparati z nizko frekvenčno izhodno močjo (npr. faradski tokovi) za stimulacijo kože ali mišic;
• aparati z zelo nizko enosmerno izhodno napetostjo (npr. galvanski tokovi), kot je elektroepilacija (odstranjevanje dlačic);
• aparati za nego kože z ultrazvočnim delovanjem;
• aparati s funkcijami vakuumskega tlaka;
• aparati za nego kože, ki se uporabljajo za taljenje voska;
• aparati za ustvarjanje hladilnega učinka na površini kože;
• aparati za čiščenje obraza;
• aparati z mikroiglami;
• plazemska peresa.
OPOMBA 102: Aparati, zajeti v tem standardu, lahko vključujejo naprave za ustvarjanje pare ali pršila.
Ta standard obravnava splošna tveganja, ki jih za vse ljudi predstavljajo aparati. 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:
– je znano, da imajo lahko osebe z obsežno in zahtevno invalidnostjo potrebe, ki niso obravnavane v tem standardu;
– so za aparate, ki so namenjeni za uporabo v vozilih ali na krovu ladij ali letal, morda potrebne dodatne zahteve;
– v številnih državah nacionalni zdravstveni organi, nacionalni organi, odgovorni za varstvo pri delu, ter drugi podobni organi lahko določijo dodatne zahteve.
Ta standard se ne uporablja za:
– aparate za izključno industrijske namene;
– aparate, ki so namenjeni za uporabo na lokacijah, kjer veljajo posebne razmere, kot je prisotnost
korozivne ali eksplozivne atmosfere (prah, hlapi ali plin);
– brivnike, električne strižnike in podobne aparate (IEC 60335-2-8);
– grelne odeje, blazine, oblačila in podobne zvijave grelne aparate (IEC 60335-2-17);
– aparate za nego kože ali las, kot so obrazne savne, sušilniki za roke, aparati za nego stopal
(IEC 60335-2-23);
– razpršilne pripomočke za porjavitev;
– aparate za nego kože z optičnim sevanjem (IEC 60335-2-27);
– grelne aparate za savne in infrardeče kabine (IEC 60335-2-53);
– kozmetične in lepotne aparate z laserji in viri močne svetlobe;
– aparate za medicinsko uporabo (IEC 60601);
– radiofrekvenčne aparate za uporabo brez stika s kožo;
– ultrazvočne aparate z usmerjenimi ultrazvočnimi pretvorniki.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60335-2-115:2023
01-julij-2023
Gospodinjski in podobni električni aparati - Varnost - 2-115. del: Posebne zahteve
za aparate za nego kože (IEC 60335-2-115:2021 + COR1:2022)
Household and similar electrical appliances - Safety - Part 2-115: Particular requirements
for skin beauty care appliances (IEC 60335-2-115:2021 + COR1:2022)
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-115:
Besondere Anforderungen für Schönheitspflegegeräte (IEC 60335-2-115:2021 +
COR1:2022)
Appareils électrodomestiques et analogues - Sécurité - Partie 2-115: Exigences
particulières pour les appareils destinés aux soins esthétiques de la peau (IEC 60335-2-
115:2021 + COR1:2022)
Ta slovenski standard je istoveten z: EN IEC 60335-2-115:2023
ICS:
13.120 Varnost na domu Domestic safety
97.170 Oprema za nego telesa Body care equipment
SIST EN IEC 60335-2-115:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60335-2-115:2023
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SIST EN IEC 60335-2-115:2023
EUROPEAN STANDARD EN IEC 60335-2-115
NORME EUROPÉENNE
EUROPÄISCHE NORM May 2023
ICS 13.120; 97.170
English Version
Household and similar electrical appliances - Safety - Part 2-115:
Particular requirements for skin beauty care appliances
(IEC 60335-2-115:2021 + COR1:2022)
Appareils électrodomestiques et analogues - Sécurité - Sicherheit elektrischer Geräte für den Hausgebrauch und
Partie 2-115: Exigences particulières pour les appareils ähnliche Zwecke - Teil 2-115: Besondere Anforderungen für
destinés aux soins esthétiques de la peau Schönheitspflegegeräte
(IEC 60335-2-115:2021 + COR1:2022) (IEC 60335-2-115:2021 + COR1:2022)
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 60335-2-115:2023 E
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SIST EN IEC 60335-2-115:2023
EN IEC 60335-2-115:2023 (E)
European foreword
This document (EN IEC 60335-2-115:2023) consists of the text of IEC 60335-2-115:2021 +
IEC 60335-2-115:2021/COR1:2022 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 60335-2-115:2023/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 60335-2-115:2021 + IEC 60335-2-115:2021/COR1:2022
was approved by CENELEC as a European Standard without any modification.
2
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SIST EN IEC 60335-2-115:2023
IEC 60335-2-115
®
Edition 1.0 2021-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Household and similar electrical appliances – Safety –
Part 2-115: Particular requirements for skin beauty care appliances
Appareils électrodomestiques et analogues – Sécurité –
Partie 2-115: Exigences particulières pour les appareils destinés aux soins
esthétiques de la peau
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 13.120; 97.170 ISBN 978-2-8322-9251-8
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 60335-2-115:2023
– 2 – IEC 60335-2-115:2021 © IEC 2021
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 9
4 General requirement . 10
5 General conditions for the tests . 10
6 Classification . 10
7 Marking and instructions . 11
8 Protection against access to live parts . 14
9 Starting of motor-operated appliances . 14
10 Power input and current . 15
11 Heating . 15
12 Void . 19
13 Leakage current and electric strength at operating temperature . 19
14 Transient overvoltages . 19
15 Moisture resistance . 19
16 Leakage current and electric strength . 19
17 Overload protection of transformers and associated circuits . 20
18 Endurance . 20
19 Abnormal operation . 20
20 Stability and mechanical hazards . 20
21 Mechanical strength . 21
22 Construction . 22
23 Internal wiring . 27
24 Components . 27
25 Supply connection and external flexible cords . 28
26 Terminals for external conductors . 28
27 Provision for earthing . 29
28 Screws and connections . 29
29 Clearances, creepage distances and solid insulation . 29
30 Resistance to heat and fire . 29
31 Resistance to rusting . 29
32 Radiation, toxicity and similar hazards . 29
Annexes . 34
Annex R (normative) Software evaluation . 34
Annex AA (normative) Estimation of the local specific absorption rate (local SAR) . 35
Annex BB (informative) Guidance to measure the dimensions of the treatment head of
a radio frequency appliance . 41
Annex CC (normative) Isolating transformers . 44
Bibliography . 45
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SIST EN IEC 60335-2-115:2023
IEC 60335-2-115:2021 © IEC 2021 – 3 –
Figure 101 – Probe for measuring surface temperatures . 31
Figure 102 – Burn threshold spread when the skin is in contact with a hot smooth
surface made of bare (uncoated) metal . 31
Figure 103 – Burn threshold spread when the skin is in contact with a hot smooth
surface made of ceramics, glass and stone materials . 32
Figure 104 – Burn threshold spread when the skin is in contact with a hot smooth
surface made of plastics . 32
Figure 105 – Circuit for testing leakage current from applied parts . 33
Figure AA.1 – Examples of radio frequency appliance output types . 40
Figure BB.1 – Use of the smallest distance between electrodes for treatment heads of
type 7 . 43
Table 101 – Maximum temperature rises for specified external accessible surfaces
other than the applied parts under normal operating conditions. 17
Table 102 – Maximum temperature rise of applied parts . 18
Table 103 – Logarithmic interpolation equations . 18
Table 104 – Output current limits for application below the neck . 24
Table 105 – Local SAR limits . 25
Table BB.1 – Dimensions and volume calculations for various types of RF treatment
heads . 41
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES – SAFETY –
Part 2-115: Particular requirements for skin beauty care appliances
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 60335-2-115 has been prepared by IEC technical committee 61:
Safety of household and similar electrical appliances.
The text of this International Standard is based on the following documents:
FDIS Report on voting
61/6132/FDIS 61/6178/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.
The language used for the development of this International Standard is English.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
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.
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SIST EN IEC 60335-2-115:2023
IEC 60335-2-115:2021 © IEC 2021 – 5 –
This part 2 is to be used in conjunction with the fifth edition of IEC 60335-1:2010 and its
amendments.
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: Particular requirements for skin beauty care appliances.
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.
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.
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 publication 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 document 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.
The contents of the corrigendum 1 (2022-04) have been included in this copy.
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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.
NOTE 1 For example, if appliances within the scope of this part 2 include an ion generator, then IEC 60335-2-65
is applicable as far as is reasonable.
When a part 2 standard does not include additional requirements to cover hazards dealt with in
Part 1, Part 1 applies.
NOTE 2 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 3 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 part 2 standards.
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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SIST EN IEC 60335-2-115:2023
IEC 60335-2-115:2021 © IEC 2021 – 7 –
HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES – SAFETY –
Part 2-115: Particular requirements for skin beauty care appliances
1 Scope
This clause of Part 1 is replaced by the following.
This part of IEC 60335 deals with the safety of electric appliances for skin beauty care of
persons and intended for household, commercial and similar purposes, their rated voltage
being not more than 250 V.
NOTE 101 Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated
appliances when operated in the battery mode.
Examples of appliances that are within the scope of this standard are
• battery-operated appliances and other DC supplied appliances for skin beauty care;
• appliances with high frequency outputs including equipment for heat-producing effects on
the skin;
• appliances with medium frequency outputs including interferential outputs, for skin
stimulation or muscle stimulation;
• appliances with low frequency outputs (e.g. faradic currents) for application such as skin
stimulation or muscle stimulation;
• appliances with extra-low voltage DC outputs (e.g. galvanic currents), such as electro-
epilation (hair removal);
• skin beauty care appliances with ultrasonic outputs;
• appliances having vacuum-pressure functions;
• skin beauty care appliances for melting wax;
• appliances intended to produce surface cooling effect on the skin;
• facial cleaning appliances;
• micro-needling appliances;
• plasma pens.
NOTE 102 Appliances covered by this standard can incorporate vapour-producing devices or spray-producing
devices.
This standard deals with the common hazards presented by appliances that are encountered
by all persons. 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
– it is recognized that persons having very extensive and complex disabilities can have needs beyond the level
addressed in this standard.
– for appliances intended to be used in vehicles or on board ships or aircraft, additional requirements can be
necessary;
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– in many countries, additional requirements can be specified by the national health authorities, the national
authorities responsible for the protection of labour and similar authorities.
This standard does not apply to
– appliances intended exclusively for industrial purposes;
– appliances intended to be used in locations where special conditions prevail, such as the
presence of a corrosive or explosive atmosphere (dust, vapour or gas);
– shavers, hair clippers and similar appliances (IEC 60335-2-8);
– blankets, pads, clothing and similar flexible heating appliances (IEC 60335-2-17);
– appliances for skin or hair care such as facial saunas, hand dryers, foot care appliances
(IEC 60335-2-23);
– spray tanning appliances;
– appliances for skin exposure to optical radiation (IEC 60335-2-27);
– sauna heating appliances and infrared cabins (IEC 60335-2-53);
– cosmetic and beauty care appliances incorporating lasers and intense light sources
(IEC 60335-2-113);
– appliances intended for medical purposes (IEC 60601);
– radio frequency appliances without contact to the skin;
– ultrasound appliances provided with focusing ultrasound transducers.
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
IEC 60584-1, Thermocouples – Part 1: EMF specifications and tolerances
IEC 60601-2-5:2009, Medical electrical equipment – Part 2-5: Particular requirements for the
basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 61558-2-4:2009, Safety of transformers, reactors, power supply units and similar products
for supply voltages up to 1 100 V – Part 2-4: Particular requirements and tests for isolating
transformers and power supply units incorporating isolating transformers
IEC 61689:2013, Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 0,5 MHz to 5 MHz
IEC 62127-1, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of
medical ultrasonic fields up to 40 MHz
IEC 63009:2019, Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 20 kHz to 500 kHz
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
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SIST EN IEC 60335-2-115:2023
IEC 60335-2-115:2021 © IEC 2021 – 9 –
3 Terms and definitions
This clause of Part 1 is applicable except as follows.
3.1 Definitions relating to physical characteristics
3.1.9 Replacement:
normal operation
conditions under which the appliance is operated as in normal use in accordance with the
manufacturer’s instructions
Note 1 to entry: Appliances also producing vapour are operated in the normal position of use and filled with liquid.
Liquid is added, when necessary, to maintain the vapour output
3.1.101
local specific absorption rate
local SAR
amount of radio frequency power absorbed by cubical tissue with a mass of 10 g
Note 1 to entry: Unit: W/kg.
3.2 Definitions relating to means of connection
3.2.101
swivel connection
means for connecting the supply cord so that the appliance can be rotated continuously without
twisting the cord
3.5 Definitions relating to types of appliances
3.5.101
electrical stimulator
appliance intended to stimulate skin or muscle by using current going through the skin surface
3.5.102
pressurised appliance
appliance in which vapour or liquid is produced at a pressure exceeding 50 kPa and in which
the pressure does not drop to atmospheric pressure when the vapour or liquid is not supplied
3.5.103
radio frequency appliance
appliance intended to produce radiofrequency current, an electric field, magnetic field, or
electromagnetic field for application to the human body
3.5.104
ultrasound appliance
appliance intended to produce ultrasound for application to the human body
3.5.105
plasma pen
appliance intended to target the upper skin layer tissue by an electrical discharge without skin
contact
3.5.106
micro-needling appliance
appliance with an array of needles intended to penetra
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