SIST EN IEC 60335-2-115:2023

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

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

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.

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

– 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

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

– 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
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.

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.

– 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.
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;
– 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

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 penetrate the skin in a stamping motion

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3.6 Definitions relating to parts of an appliance
3.6.101
applied part
part of an appliance that in normal use necessarily comes into physical contact with the skin to
perform its function
3.6.102
biased-off switch
switch that automatically returns to the off position when its actuating member is released
3.6.103
isolating transformer
transformer, the input winding of which is electrically separated from the output winding by an
insulation at least equivalent to double insulation or reinforced insulation, that is intended
to supply an appliance or circuit at a voltage greater than safety extra-low voltage
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.
5.10 Addition:
If the appliance cannot operate as intended when applying the load resistance specified for the
tests of 10.101 and 10.102, the manufacturer or responsible agent shall provide details of a
different method to achieve the required input power or current.
5.101 Unless otherwise specified, skin beauty care appliances are tested as motor-operated
appliances, except wax-melting appliances and appliances with a liquid heating function.
5.102 For ultrasound appliances, the artificial skin used shall be based on Table BB.1 in
IEC 60601-2-5: 2009. For other appliances, 10 mm thick solidified agar shall be used for the
artificial skin. The agar to be used for the test is prepared by mixing 6 g food grade powdered
agar with 100 ml of water.
6 Classification
This clause of Part 1 is applicable except as follows.
6.1 Modification:
Hand-held appliances, appliances incorporating vapour-producing devices or spray-producing
devices and appliances that are washable according to the instructions shall be class II or
class III.
Appliances incorporating vapour-producing devices or spray-producing devices may be class I
if they are for use in beauty parlours and similar premises only.

IEC 60335-2-115:2021 © IEC 2021 – 11 –
6.2 Modification:
Appliances that are washable according to the instructions shall be at least IPX7. Parts that are
intended to be fixed, detachable power supply parts fitted in flexible cords or provided with
pins for insertion into socket-outlets shall be at least IPX4.
This classification does not apply to parts of class III construction.
6.101 Appliances shall be one of the following types:
− appliances suitable for household use;
− appliances for use in beauty parlours only.
NOTE Appliances for household use can also be used in beauty parlours and similar premises.
Micro-needling appliances shall be appliances for use in beauty parlours and similar premises
only.
Compliance is checked by inspection and by the relevant tests.
7 Marking and instructions
This clause of Part 1 is applicable except as follows.
7.1 Addition:
Appliances intended to deliver current to the human body shall be marked with symbol
ISO 7000-0790 (2004-01).
Wax-melting appliances that are filled manually shall be marked with the maximum and
minimum wax levels.
Appliances, that are not suitable for use in a bath or shower shall be marked with the prohibition
sign ISO 7010-P026 (2011-05) or with the substance of the following:
WARNING: Do not use this appliance in a bathtub, shower, or water filled reservoir
Electrical stimulators capable of delivering output values in excess of 10 mA or 10 V shall be
marked near the applied part connections with symbol ISO 7000-0434A (2004-01).
If ultrasound appliances have replaceable ultrasound probes, the beam non-uniformity ratio
(BNR) shall be marked on the probe. For ultrasound appliances that have non-replaceable
ultrasound probes, the BNR shall be marked on the appliance.
If the appliance is intended to be only used in beauty parlours and similar premises, it shall be
marked with the prohibition sign “Not for household use” or with the substance of the following:
WARNING: This appliance is not for household use
NOTE For certain types of appliances, there can be national regulations regarding their use by appropriately trained
persons.
– 12 – IEC 60335-2-115:2021 © IEC 2021
7.6 Addition:
Do not use this device in a
[prohibition sign ISO 7010-P026
bathtub, shower, or water-
(2011-05)]
filled reservoir
[prohibition sign] Not for household use

7.10 Addition:
For appliances delivering current to the human body, timing controls used to regulate the
duration of operation shall be clearly and indelibly marked at regular intervals over the complete
timing range to indicate time settings. Time settings may also be indicated using digital displays.
For radio frequency appliances, controls used to regulate the maximum output power or
maximum output energy shall be clearly and indelibly marked at regular intervals over the
complete output range to indicate the output settings levels. The output levels shall be in the
same units as the maximum values or as a percentage of the maximum values.
7.12 Addition:
If prohibition sign ISO 7010-P026 (2011-05) is used, its meaning shall be explained using the
substance of the following:
WARNING: Do not use this appliance near bathtubs, showers or water-filled reservoirs
If the prohibition sign “Not for household use” is used, its meaning shall be explained using the
substance of the following:
WARNING: This appliance is not for household use
As applicable, the instructions shall state the substance of the following:
− use of this appliance may cause discomfort or adverse effect to, persons suffering from skin
disease or inflammation of the skin, persons with sensitive skin and persons having an
allergic constitution. Stop using it if any discomfort occurs;
− this appliance is not to be used on the parts where the integrity of the skin is damaged (such
as burns, blisters, lesions, incision, wounds, active skin disease or infection);
− this appliance shall not be used by, or on, persons wearing implants not compatible with its
use;
− this appliance shall not be used by or on persons up to and including 14 years of age;
− WARNING: Adverse effects may occur if the instructions are not followed;
− WARNING: Prolonged or repeated application on one site may potentially damage the skin;
− WARNING: Do not bypass or remove the inherent safety device of the appliance.
As applicable, the instructions shall include the following:
− information with regard to the proper use of the appliance;
− a caution to the user when the appliance is not suitable to treat certain parts of the human
body such as eyes and genital areas;

IEC 60335-2-115:2021 © IEC 2021 – 13 –
− information for cleaning and when necessary, disinfection of the appliance or parts of it;
− information on how to get the skin ready, such as smearing cream, before the application;
− indication of the application time (application time may be a fixed time value multiplied by
the number of cycles).
The instructions for appliances that use disposable parts or consumable materials shall list
these products and give advice on the safe disposal of them after use. The instructions shall
also include the substance of the following:
Only use disposable and consumable materials recommended by the manufacturer.
The instructions for micro-needling appliances shall include the following:
− the needle cartridge shall not be used more than once and shall be replaced after use;
− before application first clean the skin;
− an application of an inert cream/gel/liquid applied on the skin may help the gliding process
and prevent scratches;
The instructions for electrical stimulators shall contain the substance of the following:
− deactivate the output of the appliance before placing or removing the electrodes to or from
the skin (not applicable if in normal use the appliance is moved continuously over the
surface of the skin);
− do not use the appliance in conjunction with flammable based cosmetic products, unless
they are recommended by the manufacturer;
− do not use the appliance near the eyes of the person on whom the appliance is used (not
applicable for appliances having a maximum output current not exceeding 50 µA);
− do not use the appliance on persons with an implanted electronic device (for example a
cardiac pacemaker);
− do not use the appliance close to the region of the heart.
The instructions for electrical stimulators shall contain:
− information on the type (such as the shape and size) of the applied part to be used;
− information on the method of application for each particular type of operation for which the
appliance is intended.
For appliances capable of delivering output values in excess of 10 mA or 10 V, the instructions
shall contain the maximum output values allowed for each type of applied part to be used.
The instructions for wax-melting appliances shall include the following:
− information on the highest temperature of wax after melting;
− indication of the maximum load of wax allowed.
For appliances capable of producing vapour, the instructions shall contain the substance of the
following:
WARNING: In order to avoid scalding, maintain a safe distance between body parts and
the vapour outlet in normal use
− the minimum distance between human body parts and the vapour outlet in normal use;
− do not apply vapour to the eyes unless the eyes are covered by towelling or similar material.
The instructions for radio frequency appliances producing a continuous power output or a
continuous pulse train shall specify the maximum output power (W).

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The instructions for radio frequency appliances producing single pulses or pulse bursts shall
specify the maximum output energy (J).
The instructions for ultrasound appliances shall state the frequency or frequency range and
intensity in W/cm .
The instructions for ultrasound appliances shall caution the user that the appliances shall not
be used during pregnancy.
In order to avoid burning the skin, the instructions for plasma pens shall state the substance
of the following:
WARNING: Do not repeat the plasma discharge at the same place
The instructions for appliances having vacuum-pressure functions shall state the substance of
the following:
Before use visually inspect the suction head to ensure it is not damaged.
7.14 Addition:
When the instructions contain information for cleaning or disinfection of the appliance or parts
of it, compliance is also checked by rubbing the marking for 15 s with a piece of cloth soaked
with the cleaning lotion or disinfectant stated in instructions.
7.15 Addition:
The outer diameter of the circle in prohibition sign ISO 7010-P026 (2011-05) shall be at least
10 mm.
The outer diameter of the circle in prohibition sign “Not for household use” shall be at least
10 mm.
Compliance is checked by measurement.
8 Protection against access to live parts
This clause of Part 1 is applicable except as follows.
Addition:
For radio frequency appliances and electrical stimulators, the applied parts are not
considered to be live parts.
9 Starting of motor-operated appliances
This clause of Part 1 is not applicable.

IEC 60335-2-115:2021 © IEC 2021 – 15 –
10 Power input and current
This clause of part 1 is applicable except as follows:
10.101 The power input or current of electrical stimulators shall not deviate from the rated
power input or rated current marked on the appliance by more than the deviation shown in
Table 1 or Table 2 respectively.
Compliance is checked as follows.
The appliance is operated at rated voltage with a load resistance applied to the output that
maximizes the power input or current.
The appliance is operated for the maximum period specified in the instructions or maximum
setting of an incorporated timer, whichever is shorter.
The maximum value of power input or current, averaged over any 5 s period is obtained. The
maximum of the average values so obtained is taken as the maximum value of the power input
or current.
If the appliance cannot operate as intended when applying a load resistance, the manufacturer
may specify a different method to achieve the required input power or current and that method
shall be applied.
10.102 The power input or current of radio frequency appliances shall not deviate from the
rated power input or rated current marked on the appliance by more than the deviation shown
in Table 1 or Table 2 respectively.
Compliance is checked as follows.
The appliance is operated at rated voltage with a load resistance applied to the output that
maximizes the power input or current.
The appliance is operated for the maximum period specified in the instructions or maximum
setting of an incorporated timer, whichever is shorter.
The maximum value of power input or current, averaged over any 5 s period is obtained. The
maximum of the average values so obtained is taken as the maximum value of the power input
or current.
To carry out the test, a specially prepared sample may be needed with the load resistor attached
across the output applicator.
If the appliance cannot operate as intended when applying a load resistance, the manufacturer
may specify a different method to achieve the required input power or current and that method
shall be applied.
11 Heating
This clause of Part 1 is applicable except as follows.
11.1 Addition:
For appliances incorporating a swivel connection, compliance is also checked by the test
of 11.101.
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11.2 Addition:
Appliances intended to be used on a stand or attached to a support are placed to give the most
unfavourable results.
Hand-held appliances with an integral rest are also tested when placed on their rest away from
the walls of the test corner.
11.3 Addition:
Where the external accessible surfaces, other than the applied parts, are suitably flat and
access permits, then the test probe of Figure 101 is used to measure the temperature rises of
external accessible surfaces specified in Table 101. The probe is applied with a force of
4 N ± 1 N to the surfac
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