IEC 60335-2-115:2021

Household and similar electrical appliances - Safety - Part 2-115: Particular requirements for skin beauty care appliances

IEC 60335-2-115:2021 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.
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 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.
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.
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 (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.
This part 2 is to be used in conjunction with the fifth edition of IEC 60335-1:2010 and its amendments.
The contents of the corrigendum of April 2022 have been included in this copy.

Appareils électrodomestiques et analogues - Sécurité - Partie 2-115: Exigences particulières pour les appareils destinés aux soins esthétiques de la peau

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 appareils destinés aux soins des pieds (IEC 60335-2-23);
- aux appareils de bronzage par vaporisation;
- aux appareils d'exposition de la peau aux rayonnements optiques (IEC 60335-2-27);
- aux appareils de chauffage de saunas et aux cabines infrarouges (IEC 60335-2-53);
- aux appareils destinés aux soins cosmétiques et esthétiques comportant des lasers et des sources de lumière de forte intensité (IEC 60335-2-113);
- aux appareils destinés à des usages médicaux (IEC 60601);
- aux appareils à radiofréquences sans contact avec la peau;
- aux appareils à ultrasons équipés de transducteurs à ultrasons avec focalisation.
La

General Information

• Status: Published
• Publication Date: 10-Mar-2021
• ICS: 13.120 - Domestic safety
• ICS: 97.170 - Body care equipment
• Technical Committee: TC 61 - Safety of household and similar electrical appliances
• Current Stage: PPUB - Publication issued
• Completion Date: 11-Mar-2021

Standards Content (Sample)

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
IEC 60335-2-115:2021-03(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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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– 4 – IEC 60335-2-115:2021 © IEC 2021
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

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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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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.

---------------------- Page: 7 ----------------------
– 6 – IEC 60335-2-115:2021 © IEC 2021
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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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;
---------------------- Page: 9 ----------------------
– 8 – IEC 60335-2-115:2021 © IEC 2021

– 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

---------------------- Page: 10 ----------------------
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

con
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