IEC 60335-2-113:2016
(Main)Household and similar electrical appliances - Safety - Part 2-113: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources
Household and similar electrical appliances - Safety - Part 2-113: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources
IEC 60335-2-113:2016 deals with the safety of cosmetic and beauty care appliances incorporating lasers or intense light sources for household and similar purposes, where their operation relies on contact with the skin, their rated voltage being not more than 250 V. Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard. Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated appliances when operated in the battery mode. This standard covers appliances with a light emitting surface less than 25 cm2. Appliances with a light emitting surface equal to or greater than 25 cm2 are within the scope of IEC 60335-2-27. Appliances not intended for normal household use but which nevertheless may be a source of danger to the public such as appliances intended to be used in beauty salons and similar premises are also within the scope of this standard. Appliances covered by the scope of this standard include but are not limited to:
- appliances for control of hair growth and
- appliances for skin and beauty care incorporating lasers or intense light sources (ILS). Appliances incorporating lasers or intense light sources (ILS) either heat up hair follicles or skin tissue to produce thermal effects or to produce photo-biological effects from specific wavelengths. As far as is practicable, this standard deals with the common hazards presented by appliances that are encountered by all persons in and around the home. However, in general, it does not take into account:
- persons (including children) whose physical, sensory or mental capabilities or lack of experience and knowledge prevents them from using the appliance safely without supervision or instruction or
- children playing with the appliance. The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this standard be adopted for implementation nationally not earlier than 12 months or later than 36 months from the date of publication. Key words: Cosmetic, Beauty Care, Lasers, Intense Light Sources
This publication is to be read in conjunction with IEC 60335-1:2010.
Appareils électrodomestiques et analogues - Sécurité - Partie 2-113: Exigences particulières pour les appareils destinés aux soins cosmétiques et esthétiques comportant des lasers et des sources de lumière de forte intensité
IEC 60335-2-113:2016 traite de la sécurité des appareils de soins cosmétiques et esthétiques comportant des lasers ou des sources de lumière de forte intensité pour usages domestiques et analogues, dont le fonctionnement dépend du contact avec la peau et dont la tension assignée n'est pas supérieure à 250 V. NOTE 101 - Les appareils alimentés par batteries et les autres appareils alimentés en courant continu sont compris dans le domaine d'application de la présente norme. Les appareils à double alimentation, alimentés soit par le réseau soit par batteries, sont considérés comme des appareils alimentés par batteries lorsqu'ils fonctionnent en mode batterie. La présente norme couvre les appareils dont la surface électroluminescente est inférieure à 25 cm2. Les appareils dont la surface électroluminescente est supérieure ou égale à 25 cm2 relèvent du domaine d'application de l'IEC 60335-2-27. Les appareils non destinés à un usage domestique normal, mais qui néanmoins peuvent constituer une source de danger pour le public, tels que les appareils destinés à être utilisés dans des salons de beauté et des locaux analogues relèvent également du domaine d'application de la présente norme. Les appareils couverts par le domaine d'application de la présente norme incluent, sans toutefois s'y limiter:
- les appareils pour le contrôle de la pousse des cheveux et
- les appareils pour les soins de la peau et les soins esthétiques comportant des lasers ou des sources de lumière de forte intensité (ILS, intense light source). Les appareils comportant des lasers ou des sources de lumière de forte intensité (ILS) chauffent les follicules capillaires ou les tissus cutanés afin de produire des effets thermiques ou des effets photobiologiques à partir de longueurs d'ondes spécifiques. Dans la mesure du possible, la présente norme traite des dangers ordinaires présentés par les appareils, encourus par tous les individus à l'intérieur et autour de l'habitation. Cependant, la présente norme ne tient généralement pas compte:
- des personnes (y compris des enfants) dont les capacités physiques, sensorielles ou mentales ou le manque d'expérience et de connaissance les empêchent d'utiliser l'appareil en toute sécurité sans surveillance ou instruction
- ou de l'utilisation de l'appareil comme jouet par des enfants. L'attention des Comités nationaux est attirée sur le fait que les fabricants d'appareils et les organismes d'essai peuvent avoir besoin d'une période transitoire après la publication d'une nouvelle publication IEC, ou d'une publication amendée ou révisée, pour fabriquer des produits conformes aux nouvelles exigences et pour adapter leurs équipements aux nouveaux essais ou aux essais révisés. Le comité recommande que le contenu de la présente norme soit entériné au niveau national au plus tôt 12 mois ou au plus tard 36 mois après la date de publication. Mots clés: cosmétiques, soins esthétiques, lasers, sources de lumière de forte intensité
Cette publication doit être lue conjointement avec la IEC 60335-1:2010.
General Information
Relations
Overview
IEC 60335-2-113:2016 is an international safety standard developed by the International Electrotechnical Commission (IEC) specifically for household and similar electrical cosmetic and beauty care appliances that incorporate lasers and intense light sources (ILS). These appliances, operating at voltages not exceeding 250 V, are designed primarily for skin contact and used for purposes such as hair growth control and skin treatment through lasers or intense light technology.
The scope includes both mains-powered and battery-operated devices, with dual supply appliances considered battery-operated when functioning on battery mode. Devices with a light-emitting surface under 25 cm² fall under this standard’s remit, while larger light-emitting devices are covered by IEC 60335-2-27. This standard applies broadly, including appliances used in domestic settings and professional environments such as beauty salons.
As a specialized part of the IEC 60335 series-focusing on the safety of household electrical appliances-IEC 60335-2-113 supplements the general safety requirements in IEC 60335-1 with particular provisions tailored to laser and ILS beauty care appliances.
Key Topics
Safety Requirements for Cosmetic Appliances: The standard outlines essential safety criteria to protect users from hazards including electrical shock, mechanical injury, thermal burns, fire, and radiation risks associated with laser and intense light emissions.
Voltage and Power Specifications: Appliances operating at rated voltages up to 250 V, including those battery-powered, are within the scope. Dual operation modes prioritize battery safety.
Light-Emitting Surface Limitations: Appliances with a light-emitting surface smaller than 25 cm² are regulated under this standard. Larger devices are subject to additional controls under related standards.
Hazard Mitigation: IEC 60335-2-113 considers common hazards encountered by users at home or in beauty salons, covering electrical insulation, leakage current, overheating, and appropriate labeling.
User Safety Considerations: While focused on safe use by the general population, the standard acknowledges the need for supervision or instruction when used by children or individuals with sensory or cognitive limitations.
Testing and Compliance: Requirements include test conditions for endurance, abnormal operation, stability, mechanical strength, and software evaluation related to safety functions of these electrotechnical appliances.
Marking and Instructions: Clear labeling and comprehensive user manuals are mandated to ensure safe operation and awareness of risks, particularly regarding laser radiation exposure.
Applications
IEC 60335-2-113:2016 is crucial for manufacturers, testing laboratories, and regulators involved in:
Household Laser Hair Removal Devices: Ensuring electrical and radiation safety for devices designed for personal use to reduce or control hair growth.
Skin and Beauty Care Appliances: Including laser or intense light technology used for cosmetic treatments like skin rejuvenation, pigmentation correction, and acne treatment.
Battery-Operated Beauty Devices: Providing safety guidelines for portable or cordless devices used in home care or professional beauty settings.
Beauty Salon Equipment: Covering appliances that may pose risks to the public yet are not typically for household use but require harmonized safety compliance.
Product Development and Certification: Guiding product design to meet international safety requirements and supporting conformity assessment for market approval.
Related Standards
For a comprehensive safety approach, IEC 60335-2-113 is intended to be applied alongside:
IEC 60335-1: The general safety requirements for household and similar electrical appliances forming the foundation for Part 2 standards.
IEC 60335-2-27: Governs safety requirements for cosmetic and beauty care appliances with a light-emitting surface equal to or greater than 25 cm².
IEC 60825 Series: Regulations on laser safety that complement the electrotechnical safety aspects of laser-based appliances.
Manufacturers and stakeholders are encouraged to stay updated with amendments and national adoptions of IEC 60335-2-113, ensuring that devices incorporating lasers and intense light sources meet evolving safety expectations while enabling innovation in cosmetic and beauty care technology.
Keywords: IEC 60335-2-113, cosmetic appliances safety, beauty care lasers, intense light sources, electrical appliance standards, household laser devices, battery-operated cosmetic devices, laser hair removal safety, IEC cosmetic appliance regulations.
Frequently Asked Questions
IEC 60335-2-113:2016 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Household and similar electrical appliances - Safety - Part 2-113: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources". This standard covers: IEC 60335-2-113:2016 deals with the safety of cosmetic and beauty care appliances incorporating lasers or intense light sources for household and similar purposes, where their operation relies on contact with the skin, their rated voltage being not more than 250 V. Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard. Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated appliances when operated in the battery mode. This standard covers appliances with a light emitting surface less than 25 cm2. Appliances with a light emitting surface equal to or greater than 25 cm2 are within the scope of IEC 60335-2-27. Appliances not intended for normal household use but which nevertheless may be a source of danger to the public such as appliances intended to be used in beauty salons and similar premises are also within the scope of this standard. Appliances covered by the scope of this standard include but are not limited to: - appliances for control of hair growth and - appliances for skin and beauty care incorporating lasers or intense light sources (ILS). Appliances incorporating lasers or intense light sources (ILS) either heat up hair follicles or skin tissue to produce thermal effects or to produce photo-biological effects from specific wavelengths. As far as is practicable, this standard deals with the common hazards presented by appliances that are encountered by all persons in and around the home. However, in general, it does not take into account: - persons (including children) whose physical, sensory or mental capabilities or lack of experience and knowledge prevents them from using the appliance safely without supervision or instruction or - children playing with the appliance. The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this standard be adopted for implementation nationally not earlier than 12 months or later than 36 months from the date of publication. Key words: Cosmetic, Beauty Care, Lasers, Intense Light Sources This publication is to be read in conjunction with IEC 60335-1:2010.
IEC 60335-2-113:2016 deals with the safety of cosmetic and beauty care appliances incorporating lasers or intense light sources for household and similar purposes, where their operation relies on contact with the skin, their rated voltage being not more than 250 V. Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard. Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated appliances when operated in the battery mode. This standard covers appliances with a light emitting surface less than 25 cm2. Appliances with a light emitting surface equal to or greater than 25 cm2 are within the scope of IEC 60335-2-27. Appliances not intended for normal household use but which nevertheless may be a source of danger to the public such as appliances intended to be used in beauty salons and similar premises are also within the scope of this standard. Appliances covered by the scope of this standard include but are not limited to: - appliances for control of hair growth and - appliances for skin and beauty care incorporating lasers or intense light sources (ILS). Appliances incorporating lasers or intense light sources (ILS) either heat up hair follicles or skin tissue to produce thermal effects or to produce photo-biological effects from specific wavelengths. As far as is practicable, this standard deals with the common hazards presented by appliances that are encountered by all persons in and around the home. However, in general, it does not take into account: - persons (including children) whose physical, sensory or mental capabilities or lack of experience and knowledge prevents them from using the appliance safely without supervision or instruction or - children playing with the appliance. The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this standard be adopted for implementation nationally not earlier than 12 months or later than 36 months from the date of publication. Key words: Cosmetic, Beauty Care, Lasers, Intense Light Sources This publication is to be read in conjunction with IEC 60335-1:2010.
IEC 60335-2-113:2016 is classified under the following ICS (International Classification for Standards) categories: 13.120 - Domestic safety; 97.170 - Body care equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 60335-2-113:2016 has the following relationships with other standards: It is inter standard links to IEC 60335-2-113:2016/AMD1:2021, IEC 60335-2-113:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase IEC 60335-2-113:2016 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of IEC standards.
Standards Content (Sample)
IEC 60335-2-113 ®
Edition 1.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Household and similar electrical appliances – Safety –
Part 2-113: Particular requirements for cosmetic and beauty care appliances
incorporating lasers and intense light sources
Appareils électrodomestiques et analogues – Sécurité –
Partie 2-113: Exigences particulières pour les appareils destinés aux soins
cosmétiques et esthétiques comportant des lasers et des sources de lumière
de forte intensité
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IEC 60335-2-113 ®
Edition 1.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Household and similar electrical appliances – Safety –
Part 2-113: Particular requirements for cosmetic and beauty care appliances
incorporating lasers and intense light sources
Appareils électrodomestiques et analogues – Sécurité –
Partie 2-113: Exigences particulières pour les appareils destinés aux soins
cosmétiques et esthétiques comportant des lasers et des sources de lumière
de forte intensité
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 13.120; 97.170 ISBN 978-2-8322-3309-2
– 2 – IEC 60335-2-113:2016 © IEC 2016
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references. 7
3 Terms and definitions . 7
4 General requirement . 8
5 General conditions for the tests . 8
6 Classification . 9
7 Marking and instructions . 9
8 Protection against access to live parts . 11
9 Starting of motor-operated appliances . 11
10 Power input and current . 11
11 Heating . 11
12 Void . 12
13 Leakage current and electric strength at operating temperature . 12
14 Transient overvoltages. 12
15 Moisture resistance . 12
16 Leakage current and electric strength . 12
17 Overload protection of transformers and associated circuits . 12
18 Endurance . 12
19 Abnormal operation . 12
20 Stability and mechanical hazards . 12
21 Mechanical strength . 12
22 Construction . 13
23 Internal wiring . 17
24 Components . 17
25 Supply connection and external flexible cords . 17
26 Terminals for external conductors . 18
27 Provision for earthing . 18
28 Screws and connections . 18
29 Clearances, creepage distances and solid insulation . 18
30 Resistance to heat and fire . 18
31 Resistance to rusting . 19
32 Radiation, toxicity and similar hazards . 19
Annexes . 20
Annex R (normative) Software evaluation . 20
Bibliography . 21
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES –
SAFETY –
Part 2-113: Particular requirements for cosmetic and beauty care
appliances incorporating lasers and intense light sources
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This part of International Standard IEC 60335 has been prepared by IEC technical committee
61: Safety of household and similar electrical appliances.
The text of this standard is based on the following documents:
FDIS Report on voting
61/5112/FDIS 61/5132/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
– 4 – IEC 60335-2-113:2016 © IEC 2016
This part 2 is to be used in conjunction with the latest edition of IEC 60335-1 and its
amendments. It was established on the basis of the fifth edition (2010) of that standard.
NOTE 1 When “Part 1” is mentioned in this standard, it refers to IEC 60335-1.
This part 2 supplements or modifies the corresponding clauses in IEC 60335-1, so as to
convert that publication into the IEC standard: Safety requirements for cosmetic and beauty
care appliances incorporating lasers and intense light sources.
When a particular subclause of Part 1 is not mentioned in this part 2, that subclause applies
as far as is reasonable. When this standard states “addition”, “modification” or “replacement”,
the relevant text in Part 1 is to be adapted accordingly.
NOTE 2 The following numbering system is used:
– subclauses, tables and figures that are numbered starting from 101 are additional to those in Part 1;
– unless notes are in a new subclause or involve notes in Part 1, they are numbered starting from 101, including
those in a replaced clause or subclause;
– additional annexes are lettered AA, BB, etc.
NOTE 3 The following print types are used:
– requirements: in roman type;
– test specifications: in italic type;
– notes: in small roman type.
Words in bold in the text are defined in Clause 3. When a definition concerns an adjective, the adjective and the
associated noun are also in bold.
A list of all parts of the IEC 60335 series, under the general title: Household and similar
electrical appliances – Safety, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE 4 The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests.
It is the recommendation of the committee that the content of this standard be adopted for implementation
nationally not earlier than 12 months or later than 36 months from the date of publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
INTRODUCTION
It has been assumed in the drafting of this International Standard that the execution of its
provisions is entrusted to appropriately qualified and experienced persons.
This standard recognizes the internationally accepted level of protection against hazards such
as electrical, mechanical, thermal, fire and radiation of appliances when operated as in
normal use taking into account the manufacturer's instructions. It also covers abnormal
situations that can be expected in practice and takes into account the way in which
electromagnetic phenomena can affect the safe operation of appliances.
This standard takes into account the requirements of IEC 60364 as far as possible so that
there is compatibility with the wiring rules when the appliance is connected to the supply
mains. However, national wiring rules may differ.
If an appliance within the scope of this standard also incorporates functions that are covered
by another part 2 of IEC 60335, the relevant part 2 is applied to each function separately, as
far as is reasonable. If applicable, the influence of one function on the other is taken into
account.
When a part 2 standard does not include additional requirements to cover hazards dealt with
in Part 1, Part 1 applies.
NOTE 1 This means that the technical committees responsible for the part 2 standards have determined that it is
not necessary to specify particular requirements for the appliance in question over and above the general
requirements.
This standard is a product family standard dealing with the safety of appliances and takes
precedence over horizontal and generic standards covering the same subject.
NOTE 2 Horizontal and generic standards covering a hazard are not applicable since they have been taken into
consideration when developing the general and particular requirements for the IEC 60335 series of standards. For
example, in the case of temperature requirements for surfaces on many appliances, generic standards, such as
ISO 13732-1 for hot surfaces, are not applicable in addition to Part 1 or this part 2 standard. This does not apply to
IEC 60825-1, except where specified in this part 2 standard.
An appliance that complies with the text of this standard will not necessarily be considered to
comply with the safety principles of the standard if, when examined and tested, it is found to
have other features that impair the level of safety covered by these requirements.
An appliance employing materials or having forms of construction differing from those detailed
in the requirements of this standard may be examined and tested according to the intent of
the requirements and, if found to be substantially equivalent, may be considered to comply
with the standard.
– 6 – IEC 60335-2-113:2016 © IEC 2016
HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES –
SAFETY –
Part 2-113: Particular requirements for cosmetic and beauty care
appliances incorporating lasers and intense light sources
1 Scope
This clause of Part 1 is replaced by the following.
This International Standard deals with the safety of cosmetic and beauty care appliances
incorporating lasers or intense light sources for household and similar purposes, where their
operation relies on contact with the skin, their rated voltage being not more than 250 V.
NOTE 101 Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard.
Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated appliances
when operated in the battery mode.
This standard covers appliances with a light emitting surface less than 25 cm . Appliances
with a light emitting surface equal to or greater than 25 cm are within the scope
of IEC 60335-2-27.
Appliances not intended for normal household use but which nevertheless may be a source of
danger to the public such as appliances intended to be used in beauty salons and similar
premises are also within the scope of this standard.
Appliances covered by the scope of this standard include but are not limited to:
– appliances for control of hair growth;
– appliances for skin and beauty care incorporating lasers or intense light sources (ILS).
NOTE 102 Appliances incorporating lasers or intense light sources (ILS) either heat up hair follicles or skin
tissue to produce thermal effects or to produce photo-biological effects from specific wavelengths.
As far as is practicable, this standard deals with the common hazards presented by
appliances that are encountered by all persons in and around the home. However, in general,
it does not take into account:
– persons (including children) whose physical, sensory or mental capabilities or lack of
experience and knowledge prevents them from using the appliance safely without
supervision or instruction;
– children playing with the appliance.
NOTE 103 Attention is drawn to the fact that in many countries additional requirements are specified by the
national health authorities.
NOTE 104 This standard does not apply to
– appliances for medical purposes (IEC 60601);
– appliances for skin or hair care (IEC 60335-2-23);
– appliances for nail hardening;
– appliances for skin exposure to optical radiation with a light emitting surface equal to or greater than 25 cm
(IEC 60335-2-27).
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and
requirements
IEC 62471:2006, Photobiological safety of lamps and lamp systems
ISO 7010, Graphical symbols – Safety colours and safety signs – Registered safety signs
ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical
practice
3 Terms and definitions
This clause of Part 1 is applicable except as follows.
Addition:
Additional terms and definitions given in IEC 60825-1 and IEC 62471 are also applicable.
3.1.9 Replacement:
normal operation
use of the appliance applied in accordance with the manufacturer’s instructions
3.101
accessible emission limit
AEL
maximum accessible emission permitted within a particular class of laser product or ILS risk
group
Note 1 to entry: Accessible emission limit is hereinafter referred to as AEL.
Note 2 to entry: Wherever the text refers to “emission level not exceeding the AEL” or similar wording, it is
implicit that the accessible emission is determined following the measurement criteria specified in Clause 5 of
IEC 60825-1:2014 or Clause 5 of IEC 62471:2006.
3.102
Class 1C laser product
laser product that during operation does not permit stray optical radiation in excess of the
AEL of Class 1 for applicable wavelengths and emission durations
3.103
embedded laser
laser that emits radiation within the AEL of Class 3R laser products, Class 3B laser
products or Class 4 laser products, and that is incorporated in an appliance classified in a
lower class
3.104
good contact
state that is established when the applicator is positioned at the target skin so that the skin
acts to effectively prevent stray optical radiation exposure in excess of the ocular MPE
Note 1 to entry: Hazardous radiation emission refers to levels in excess of the ocular MPE.
– 8 – IEC 60335-2-113:2016 © IEC 2016
3.105
intense light source
source of intense broadband non-laser light which emits optical radiation exceeding that of
the exempt group, and that is intended to cause a thermal or photo-chemical effect to the
target tissue
Note 1 to entry: Intense light sources are hereinafter referred to as ILS.
Note 2 to entry: ILS may incorporate continuously emitting or pulsed xenon light bulbs, incandescent bulbs, LEDs
or similar.
3.106
risk group
lamp classification according to IEC 62471
3.107
stray optical radiation
optical energy that is unintentionally emitted from the applicator, including scattered, reflected,
and leakage radiation
3.108
maximum permissible exposure
level of optical radiation to which, under normal circumstances, persons may be exposed
without suffering adverse effects
Note 1 to entry: Maximum permissible exposure is hereinafter referred to as MPE.
3.109
swivel connection
means for connecting the supply cord so that the appliance can be rotated continuously
without twisting the cord
4 General requirement
This clause of Part 1 is applicable.
5 General conditions for the tests
This clause of Part 1 is applicable except as follows.
5.2 Addition:
The additional test of 25.14 for hand-held appliances is carried out on a separate appliance.
5.101 Beauty care appliances are tested as a motor-operated appliance.
5.102 Where a test specification requires testing on skin or artificial skin, the artificial skin
shall be similar in softness, heat capacity and reflection conditions of human skin.
NOTE Suitable material for the artificial skin is silicone rubber with a thickness of 10 mm [e.g., (Wacker Chemie
AG Elastosil RT 604, A/B) mix ratio = 9:1 with 0,6 % colour (Max Factor Creme Puff Compact Powder – 41 Medium
Beige) and 6 % scattering material (Sigma Aldrich Chemical Co. AL203)] .
______________
This information is given for the convenience of users of this document and does not constitute an endorsement
by IEC of these products.
For appliances with interlock system using a capacitive detection, the artificial skin shall also
be similar in dielectric constant condition of human skin.
6 Classification
This clause of Part 1 is applicable.
7 Marking and instructions
This clause of Part 1 is applicable except as follows.
7.1 Addition:
Appliances shall also be marked with the following, if applicable:
– a warning that intense visible and invisible optical radiation emitted from the device may
cause eye injury;
– indication to avoid eye exposure;
– symbol ISO 7000-1329 (2004-01), for Class 1C laser product appliances;
– symbol ISO 7010-W027 (2011-05), for appliances incorporating an ILS;
– symbol ISO 7000-0790 (2004-01) to indicate the need to consult the user manual.
7.6 Addition:
[symbol ISO 7000-1329 (2004-01)] laser beam
[symbol ISO 7010-W027 (2011-05)] Warning; Optical radiation
7.12 Addition:
The instructions shall include the substance of the following warnings, if applicable:
WARNING. Possible eye injury (potentially leading to loss of vision) or skin injury if
instructions are not followed. Read and follow the instructions.
WARNING. Only use disposable and consumable materials recommended by the
manufacturer.
WARNING. Damage of the skin may occur after prolonged or repeated surface application
on one site.
WARNING. Misuse can lead to eye damage. Protect the eye from exposure. Do not use
the appliance over the eye lids or close to the eye.
WARNING. Do not override the safety mechanisms inherent to the device.
WARNING. If taking a photosensitizing medication or herbal remedy, seek medical advice
prior to application of the appliance as use may harm the skin.
– 10 – IEC 60335-2-113:2016 © IEC 2016
The instructions shall include the substance of the following, if applicable:
– do not use the appliance in areas where skin integrity has been impaired (for example, in
the presence of burns, lesions, blisters, scars, cuts, open wounds, active skin disease,
recent sun tan or sun burn, and/ or infection);
– this appliance is not intended for the treatment of medical conditions. Medical advice
should be sought to address, for example, moles, skin rash, itchy skin, skin fungus or
infection, skin bumps, or skin tags;
– indications for how to use on various skin colour pigmentations, hair colours and hair
thicknesses;
– these appliances are not to be used on children;
– avoid over-usage which includes excessive passes, stacking of pulses and/or increased
frequency of use;
– verify that there is no visible damage to the emission optic or the appliance housing. If
there is damage, do not use appliance;
– a description of how to test the skin reaction prior to the full area treatment;
– a description of how to prepare the skin before application, e.g. by applying lotions or
removal of make-up;
– information concerning handling, disinfection, cleaning, care and storage of the device;
– information on use in the presence of injectable filler and toxins;
– a list of possible side effects, including blistering, pain, and scarring;
– when to seek medical advice prior to or during a use cycle;
– white or grey hair cannot be epilated;
– how to prepare the hair prior to use.
The instructions of appliances that use disposable parts or consumable materials shall list
these products and give advice on the safe disposal of them after use.
For appliance incorporating lasers, the instructions shall additionally provide specific
information about:
– the maximum laser output delivered to the skin;
– the embedded laser class, wavelength/s, pulse duration, pulse repetition rate, output
radiant power or radiant energy;
2 2
– irradiance in W/m or radiant exposure in J/m for each output setting of the device;
– the anticipated effects of the laser radiation on the skin, for a Class 1C laser product
appliance that contains an embedded laser;
– repairs and, if applicable, recommended replacement components and accessories
compatible with the product.
For appliances incorporating ILS the instructions shall additionally provide specific information
about:
– the appliance optical output, wavelength range, pulse duration, pulse repetition rate,
output irradiance or radiance;
– repairs and, if applicable, recommended replacement components and accessories that
are compatible with the product, including lamps, timers, reflectors, and filters.
If symbol ISO 7000-1329 or symbol ISO 7010-W027 is used, its meaning shall be explained.
7.14 Addition:
The outer diameter of symbol ISO 7000-1329 and the height of the triangle in symbol
ISO 7010-W027 shall be at least 10 mm.
7.15 Addition:
Warnings on the housing shall be permanently fixed, legible, and clearly visible during use,
maintenance, and service. They shall be so positioned that they can be read without the
necessity for human exposure to laser radiation in excess of the AEL for Class 1 laser
product or optical radiation in excess of the AEL of the exempt group.
8 Protection against access to live parts
This clause of Part 1 is applicable.
9 Starting of motor-operated appliances
This clause of Part 1 is not applicable.
10 Power input and current
This clause of Part 1 is applicable.
11 Heating
This clause of Part 1 is applicable except as follows.
11.2 Addition:
Appliances intended to be used on a stand or attached to a support are placed to give the
most unfavourable results.
11.7 Replacement:
Appliances without a timer are operated
– for 30 min, for hand-held appliances and appliances with hand-held applicators;
– until steady conditions are established, for other appliances.
Appliances incorporating a timer are operated in cycles until steady conditions are
established. Each cycle consists of the maximum operating time of the timer followed by
either the programmed rest period, or a minimum rest period of 5 s.
11.8 Addition:
An appliance intended to be operated when in contact with the skin shall be tested using the
artificial skin. All other appliances are tested in air. The maximum temperature rise of
appliance parts intended to be in contact with the human body in normal use shall not exceed
the following values:
– if of metals and liquids 26 K
– if of glass, porcelain and vitreous material 31 K
– if of moulded material, plastics, rubber and wood 35 K
The temperature rise of the artificial skin is not measured.
– 12 – IEC 60335-2-113:2016 © IEC 2016
12 Void
13 Leakage current and electric strength at operating temperature
This clause of Part 1 is applicable.
14 Transient overvoltages
This clause of Part 1 is applicable.
15 Moisture resistance
This clause of Part 1 is applicable.
16 Leakage current and electric strength
This clause of Part 1 is applicable.
17 Overload protection of transformers and associated circuits
This clause of Part 1 is applicable.
18 Endurance
This clause of Part 1 is applicable.
19 Abnormal operation
This clause of Part 1 is applicable except as follows.
19.13 Addition:
During and after the tests, if the appliance is operational, it shall comply with Clause 32.
20 Stability and mechanical hazards
This clause of Part 1 is applicable.
21 Mechanical strength
This clause of Part 1 is applicable except as follows.
21.1 Addition:
Hand-held appliances and hand-held parts of the appliance are also subjected to the test of
21.101.
21.101 The appliance is placed on a horizontal surface positioned 700 mm above a rigidly
supported hardwood board and operated while supplied at rated voltage.
It is pulled from the surface by its supply cord and allowed to drop freely. The test is carried
out five times, the appliance being placed on the horizontal surface in different positions likely
to occur.
The appliance shall not be damaged to such an extent that compliance with this standard is
impaired. In particular, the requirements of Clauses 8 and 29 shall be fulfilled.
22 Construction
This clause of Part 1 is applicable except as follows.
22.7 Addition:
This requirement also applies to negative pressure.
22.101 Appliances incorporating rechargeable non-sealed batteries shall be ventilated.
Compliance is checked by inspection.
22.102 Appliances incorporating parts that are suspended or intended to be raised and
lowered over a person shall incorporate a safety device to prevent injury if the suspension
means fails or there is excessive travel of the part.
Compliance is checked by inspection and by manual test.
22.103 Foot-operated control devices shall be able to support the weight of a person.
Compliance is checked by applying to the foot-operated control device, in its position of
normal use, an actuating force of 1 350 N for 1 min. The force is applied over an area of
625 mm . There shall be no damage to the device that is likely to cause a hazard.
22.104 Foot-operated control devices and hand-held control devices shall not change their
control setting when inadvertently placed in an unintended position.
Compliance is checked by turning the device in all positions where the control device can be
activated or kept activated under the weight of the control and placing it on a supporting
surface. There shall not be any inadvertent change of control setting that is likely to cause a
hazard.
22.105 Appliances using vacuum or pressure aperture shall be constructed so that
– gas flow, by means of cooling gas supply, shall not exceed an output pressure of 20 kPa;
– the suction applicators or probes shall not induce a vacuum exceeding 75 kPa.
Compliance is checked by inspection and measurement.
22.106 Any appliance incorporating
– an embedded laser, other than a Class 1 laser product, Class 1M laser product, Class
2 laser product, Class 2M laser product; or
– an ILS other than those classified as exempt group in 6.1.1 of IEC 62471:2006 or
classified as risk group 1 in 6.1.2 of IEC 62471:2006
shall give a visible, audible or tactile signal when the interlock system senses good contact
with the skin and enables the appliance for emission.
– 14 – IEC 60335-2-113:2016 © IEC 2016
If a tactile signal is used, the indication of good contact shall be other than the sense of
pressure on the skin. An example of an acceptable tactile signal is vibration.
Compliance is checked by inspection and by functional tests.
22.107 If an appliance incorporates
– a laser, other than a Class 1 laser product, Class 1M laser product, Class 2 laser
product, Class 2M laser product, that emits above the AEL of a Class 1 laser product
for the skin in IEC 60825-1; or
– an ILS, other than those classified as exempt group in 6.1.1 of IEC 62471:2006 or
classified as risk group 1 in 6.1.2 of IEC 62471:2006, that emits above the AEL of
exempt group for the skin specified in 4.3.8 of IEC 62471:2006
it shall have means to assess the skin pigmentation level and means to adjust the output
according to the skin pigmentation level so that damage to the bulk tissue is avoided.
NOTE The means to assess the skin pigmentation level can be via a colour chart.
Means of assessing the pigmentation level is not required if the appliance is not capable of
damaging the bulk tissue of any skin type when set at the maximum output.
Compliance is checked by inspection. For devices without means to adjust the output, the
manufacturer shall supply a validation study on human skin showing that damage to the bulk
tissue does not occur. The study shall be a registered clinical study in accordance with good
clinical practice as described in ISO 14155.
If compliance relies on a programmable electronic circuit the software shall contain
measures to control the fault/error conditions specified in Table R.1 and it is evaluated in
accordance with the relevant requirements of Annex R.
22.108 Appliances incorporating an embedded laser other than a Class 1 laser product
shall be equipped with an interlock system which is capable of detecting whether good
contact with the human skin is established.
If continuous action by the user is required to maintain the enabled status (for example an
activation button is continuously depressed) the appliance shall keep emitting, unless good
contact with the skin is lost. While this continuous action is maintained by the user, any loss
of good contact shall be detected by the interlock system and the laser emission shall shut
off.
The time interval between loss of good contact with the skin and disabling the triggering of
laser emission shall not exceed 0,1 s. For pulsed systems, the time between loss of good
contact and disabling of emissions shall be less than the minimum pulse interval.
The emission may resume automatically if good contact is re-established within 10 s. When
the loss of good contact exceeds 10 s the appliance shall require active retriggering by the
user in order to resume emission.
Compliance is checked by the following tests.
The function of the interlock system shall be tested with a cylindrical test specimen, designed
to simulate human skin, with the following properties:
– a cylindrical rod with an outer diameter exceeding the maximal dimension of the applicator
footprint by 40 mm and having a smooth surface, made of a flexible material with a Shore
hardness not exceeding 25;
– the material shall simulate the optical properties of the skin with regard to absorption,
reflection and scattering, in order to assess the stray optical radiation;
– the surface of the artificial skin used for detecting the skin contact is modified in turn as
follows:
• dry skin is simulated using the artificial skin without any modification;
• the presence of dried sweat is simulated by using a 0,9 g/l saline solution on the
artificial skin surface, that is then air dried;
• the presence of sebum is simulated by using petroleum jelly on the artificial skin
surface.
For appliances using an auxiliary material such as a gel as specified in the instructions as the
contact means for normal operation, the test shall be performed with and without this
material.
The reaction time of the interlock system is tested by placing the output window of the
appliance applicator on the test specimen, subsequently removing the applicator from the test
specimen and the emission of light shall cease within a time interval of 0,1 s.
The output window of the appliance applicator shall be placed on the test specimen and
rotated, tilted and raised to test whether the sensors in the interlock system correctly detect
good contact with the test specimen.
If stray optical radiation from the target skin occurs it shall be measured by placing the
appliance applicator in contact with the test specimen at varying positions of orientation. The
emission level shall not exceed the AEL of Class 1 laser products as specified in Table 3 of
IEC 60825-1:2014 for an emission duration of 10 s, unless the appliance is limited to a shorter
emission duration.
If compliance with the requirement of this subclause relies on the operation of an electronic
circuit, the appliance is further tested as follows.
a) The appliance is supplied at rated voltage and operated under normal operation.
The electromagnetic phenomena tests of 19.11.4.1 to 19.11.4.7 are then applied. The tests
are carried out with surge protective devices disconnected, unless they incorporate spark
gaps.
The emission level shall be below the limit of Class 1 laser products after the loss of good
contact with the skin.
b) The appliance is supplied at rated voltage and operated under normal operation.
The fault conditions in a) to g) of 19.11.2 are then considered and, if necessary, applied one
at a time to the electronic circuit monitoring the interlock.
After and during each individual test, the emission level shall be below the AEL of Class 1
laser products after the loss of good cont
...
IEC 60335-2-113 ®
Edition 1.1 2021-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Household and similar electrical appliances – Safety –
Part 2-113: Particular requirements for cosmetic and beauty care appliances
incorporating lasers and intense light sources
Appareils électrodomestiques et analogues – Sécurité –
Partie 2-113: Exigences particulières pour les appareils destinés aux soins
cosmétiques et esthétiques comportant des lasers et des sources de lumière
de forte intensité
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IEC 60335-2-113 ®
Edition 1.1 2021-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Household and similar electrical appliances – Safety –
Part 2-113: Particular requirements for cosmetic and beauty care appliances
incorporating lasers and intense light sources
Appareils électrodomestiques et analogues – Sécurité –
Partie 2-113: Exigences particulières pour les appareils destinés aux soins
cosmétiques et esthétiques comportant des lasers et des sources de lumière
de forte intensité
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 13.120; 97.170 ISBN 978-2-8322-4173-8
IEC 60335-2-113 ®
Edition 1.1 2021-11
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Household and similar electrical appliances – Safety –
Part 2-113: Particular requirements for cosmetic and beauty care appliances
incorporating lasers and intense light sources
Appareils électrodomestiques et analogues – Sécurité –
Partie 2-113: Exigences particulières pour les appareils destinés aux soins
cosmétiques et esthétiques comportant des lasers et des sources de lumière
de forte intensité
– 2 – IEC 60335-2-113:2016+AMD1:2021 CSV
© IEC 2021
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 7
3 Terms and definitions . 7
4 General requirement . 8
5 General conditions for the tests . 8
6 Classification . 9
7 Marking and instructions . 9
8 Protection against access to live parts . 11
9 Starting of motor-operated appliances . 11
10 Power input and current . 11
11 Heating . 11
12 Void . 12
13 Leakage current and electric strength at operating temperature . 12
14 Transient overvoltages . 12
15 Moisture resistance . 12
16 Leakage current and electric strength . 12
17 Overload protection of transformers and associated circuits . 12
18 Endurance . 13
19 Abnormal operation . 13
20 Stability and mechanical hazards . 13
21 Mechanical strength . 13
22 Construction . 14
23 Internal wiring . 19
24 Components . 19
25 Supply connection and external flexible cords . 19
26 Terminals for external conductors . 20
27 Provision for earthing . 20
28 Screws and connections . 20
29 Clearances, creepage distances and solid insulation . 20
30 Resistance to heat and fire . 20
31 Resistance to rusting . 20
32 Radiation, toxicity and similar hazards . 20
Annexes . 22
Annex R (normative) Software evaluation . 22
Bibliography . 23
Figure 101 – Sign for Class 1C laser product appliances . 21
© IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES –
SAFETY –
Part 2-113: Particular requirements for cosmetic and beauty care
appliances incorporating lasers and intense light sources
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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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
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other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) 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.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60335-2-113 edition 1.1 contains the first edition (2016-04) [documents 61/5112/FDIS
and 61/5132/RVD] and its amendment 1 (2021-11) [documents 61/6367/FDIS and
61/6417/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
– 4 – IEC 60335-2-113:2016+AMD1:2021 CSV
© IEC 2021
IEC 60335-2-113 has been prepared by IEC technical committee 61: Safety of household and
similar electrical appliances.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
This part 2 is to be used in conjunction with the latest edition of IEC 60335-1 and its
amendments. It was established on the basis of the fifth edition (2010) of that standard.
NOTE 1 When “Part 1” is mentioned in this standard, it refers to IEC 60335-1.
This part 2 supplements or modifies the corresponding clauses in IEC 60335-1, so as to
convert that publication into the IEC standard: Safety requirements for cosmetic and beauty
care appliances incorporating lasers and intense light sources.
When a particular subclause of Part 1 is not mentioned in this part 2, that subclause applies
as far as is reasonable. When this standard states “addition”, “modification” or “replacement”,
the relevant text in Part 1 is to be adapted accordingly.
NOTE 2 The following numbering system is used:
– subclauses, tables and figures that are numbered starting from 101 are additional to those in Part 1;
– unless notes are in a new subclause or involve notes in Part 1, they are numbered starting from 101, including
those in a replaced clause or subclause;
– additional annexes are lettered AA, BB, etc.
NOTE 3 The following print types are used:
– requirements: in roman type;
– test specifications: in italic type;
– notes: in small roman type.
Words in bold in the text are defined in Clause 3. When a definition concerns an adjective, the adjective and the
associated noun are also in bold.
A list of all parts of the IEC 60335 series, under the general title: Household and similar
electrical appliances – Safety, can be found on the IEC website.
The committee has decided that the contents of the base publication and its amendment will
remain unchanged until the stability date indicated on the IEC web site under webstore.iec.ch
in the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE 4 The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests.
It is the recommendation of the committee that the content of this standard be adopted for implementation
nationally not earlier than 12 months or later than 36 months from the date of publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
© 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.
When a part 2 standard does not include additional requirements to cover hazards dealt with
in Part 1, Part 1 applies.
NOTE 1 This means that the technical committees responsible for the part 2 standards have determined that it is
not necessary to specify particular requirements for the appliance in question over and above the general
requirements.
This standard is a product family standard dealing with the safety of appliances and takes
precedence over horizontal and generic standards covering the same subject.
NOTE 2 Horizontal and generic standards covering a hazard are not applicable since they have been taken into
consideration when developing the general and particular requirements for the IEC 60335 series of standards. For
example, in the case of temperature requirements for surfaces on many appliances, generic standards, such as
ISO 13732-1 for hot surfaces, are not applicable in addition to Part 1 or this part 2 standard. This does not apply to
IEC 60825-1, except where specified in this part 2 standard.
An appliance that complies with the text of this standard will not necessarily be considered to
comply with the safety principles of the standard if, when examined and tested, it is found to
have other features that impair the level of safety covered by these requirements.
An appliance employing materials or having forms of construction differing from those detailed
in the requirements of this standard may be examined and tested according to the intent of
the requirements and, if found to be substantially equivalent, may be considered to comply
with the standard.
– 6 – IEC 60335-2-113:2016+AMD1:2021 CSV
© IEC 2021
HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES –
SAFETY –
Part 2-113: Particular requirements for cosmetic and beauty care
appliances incorporating lasers and intense light sources
1 Scope
This clause of Part 1 is replaced by the following.
This International Standard deals with the safety of cosmetic and beauty care appliances
incorporating lasers or intense light sources for household and similar purposes, where their
operation relies on contact with the skin, their rated voltage being not more than 250 V.
NOTE 101 Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard.
Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated appliances
when operated in the battery mode.
This standard covers appliances with a light emitting surface less than 25 cm . Appliances
with a light emitting surface equal to or greater than 25 cm are within the scope
of IEC 60335-2-27.
Appliances not intended for normal household use but which nevertheless may be a source of
danger to the public such as appliances intended to be used in beauty salons and similar
premises are also within the scope of this standard.
Appliances covered by the scope of this standard include but are not limited to:
– appliances for control of hair growth;
– appliances for skin and beauty care incorporating lasers or intense light sources (ILS).
NOTE 102 Appliances incorporating lasers or intense light sources (ILS) either heat up hair follicles or skin
tissue to produce thermal effects or to produce photo-biological effects from specific wavelengths.
As far as is practicable, this standard deals with the common hazards presented by
appliances that are encountered by all persons in and around the home. However, in general,
it does not take into account:
– persons (including children) whose physical, sensory or mental capabilities or lack of
experience and knowledge prevents them from using the appliance safely without
supervision or instruction;
– children playing with the appliance.
NOTE 103 Attention is drawn to the fact that in many countries additional requirements are specified by the
national health authorities.
NOTE 104 This standard does not apply to
– appliances for medical purposes (IEC 60601);
– appliances for skin or hair care (IEC 60335-2-23);
– appliances for nail hardening;
– appliances for skin exposure to optical radiation with a light emitting surface equal to or greater than 25 cm
(IEC 60335-2-27).
© IEC 2021
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and
requirements
IEC 62471:2006, Photobiological safety of lamps and lamp systems
ISO 7010:2019, Graphical symbols – Safety colours and safety signs – Registered safety
signs
ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical
practice
3 Terms and definitions
This clause of Part 1 is applicable except as follows.
Addition:
Additional terms and definitions given in IEC 60825-1:2014 and IEC 62471:2006 are also
applicable.
3.1.9 Replacement:
normal operation
use of the appliance applied in accordance with the manufacturer’s instructions
3.101
accessible emission limit
AEL
maximum accessible emission permitted within a particular class of laser product or ILS risk
group
Note 1 to entry: Accessible emission limit is hereinafter referred to as AEL.
Note 2 to entry: Wherever the text refers to “emission level not exceeding the AEL” or similar wording, it is
implicit that the accessible emission is determined following the measurement criteria specified in Clause 5 of
IEC 60825-1:2014 or Clause 5 of IEC 62471:2006.
3.102
Class 1C laser product
laser product that during operation does not permit stray optical radiation in excess of the
AEL of Class 1 for applicable wavelengths and emission durations
3.103 Void
embedded laser
laser that emits radiation within the AEL of Class 3R laser products, Class 3B laser
products or Class 4 laser products, and that is incorporated in an appliance classified in a
lower class
3.104
good contact
state that is established when the applicator is positioned at the target skin so that the skin
acts to effectively prevent stray optical radiation exposure in excess of the ocular MPE
– 8 – IEC 60335-2-113:2016+AMD1:2021 CSV
© IEC 2021
emission in excess of the AEL for Class 1 laser products or the emission limits for the exempt
group for intense light sources
Note 1 to entry: Hazardous radiation emission refers to levels in excess of the ocular MPE.
3.105
intense light source
source of intense broadband non-laser light which emits optical radiation exceeding that of
the exempt group, and that is intended to cause a thermal or photo-chemical effect to the
target tissue
Note 1 to entry: Intense light sources are hereinafter referred to as ILS.
Note 2 to entry: ILS may incorporate continuously emitting or pulsed xenon light bulbs, incandescent bulbs, LEDs
or similar.
3.106
risk group
lamp classification according to IEC 62471
3.107
stray optical radiation
optical energy that is unintentionally emitted from the applicator, including scattered, reflected,
and leakage radiation
3.108 Void
maximum permissible exposure
level of optical radiation to which, under normal circumstances, persons may be exposed
without suffering adverse effects
Note 1 to entry: Maximum permissible exposure is hereinafter referred to as MPE.
3.109
swivel connection
means for connecting the supply cord so that the appliance can be rotated continuously
without twisting the cord
4 General requirement
This clause of Part 1 is applicable.
5 General conditions for the tests
This clause of Part 1 is applicable except as follows.
5.2 Addition:
The additional test of 25.14 for hand-held appliances is carried out on a separate appliance.
5.101 Beauty care appliances are tested as a motor-operated appliance.
5.102 Where a test specification requires testing on skin or artificial skin, the artificial skin
shall be similar in softness, heat capacity and reflection conditions of human skin.
© IEC 2021
NOTE Suitable material for the artificial skin is silicone rubber with a thickness of 10 mm [e.g., (Wacker Chemie
AG Elastosil RT 604, A/B) mix ratio = 9:1 with 0,6 % colour (Max Factor Creme Puff Compact Powder – 41 Medium
Beige) and 6 % scattering material (Sigma Aldrich Chemical Co. AL203)] .
For appliances with interlock system using a capacitive detection, the artificial skin shall also
be similar in dielectric constant condition of human skin.
6 Classification
This clause of Part 1 is applicable.
7 Marking and instructions
This clause of Part 1 is applicable except as follows.
7.1 Addition:
Appliances shall also be marked with the following, if applicable:
– a warning that intense visible and invisible optical radiation emitted from the device may
cause eye injury;
– indication to avoid eye exposure;
– symbol ISO 7000-1329 (2004-01), for Class 1C laser product appliances;
• sign shown in Figure 101; or
• warning sign ISO 7010-W004 (2019-07) and the substance of the following:
Laser radiation. Follow instructions. Class 1C laser product.
– symbol warning sign ISO 7010-W027 (2011-05), for appliances incorporating an ILS;
– symbol ISO 7000-0790 (2004-01) to indicate the need to consult the user manual.
7.6 Addition:
[symbol ISO 7000-1329 (2004-01)] laser beam
[warning sign ISO 7010-W004 (2019-07)] Warning: Laser beam
[symbol warning sign ISO 7010-W027
Warning; Optical radiation
(2011-05 2019-07)]
______________
This information is given for the convenience of users of this document and does not constitute an endorsement
by IEC of these products.
– 10 – IEC 60335-2-113:2016+AMD1:2021 CSV
© IEC 2021
7.12 Addition:
The instructions shall include the substance of the following warnings, if applicable:
WARNING. Possible eye injury (potentially leading to loss of vision) or skin injury if
instructions are not followed. Read and follow the instructions.
WARNING. Only use disposable and consumable materials recommended by the
manufacturer.
WARNING. Damage of the skin may occur after prolonged or repeated surface application
on one site.
WARNING. Misuse can lead to eye damage. Protect the eye from exposure. Do not use
the appliance over the eye lids or close to the eye.
WARNING. Do not override the safety mechanisms inherent to the device.
WARNING. If taking a photosensitizing medication or herbal remedy, seek medical advice
prior to application of the appliance as use may harm the skin.
The instructions shall include the substance of the following, if applicable:
– do not use the appliance in areas where skin integrity has been impaired (for example, in
the presence of burns, lesions, blisters, scars, cuts, open wounds, active skin disease,
recent sun tan or sun burn, and/ or infection);
– this appliance is not intended for the treatment of medical conditions. Medical advice
should be sought to address, for example, moles, skin rash, itchy skin, skin fungus or
infection, skin bumps, or skin tags;
– indications for how to use on various skin colour pigmentations, hair colours and hair
thicknesses;
– these appliances are not to be used on children;
– avoid over-usage which includes excessive passes, stacking of pulses and/or increased
frequency of use;
– verify that there is no visible damage to the emission optic or the appliance housing. If
there is damage, do not use appliance;
– a description of how to test the skin reaction prior to the full area treatment;
– a description of how to prepare the skin before application, e.g. by applying lotions or
removal of make-up;
– information concerning handling, disinfection, cleaning, care and storage of the device;
– information on use in the presence of injectable filler and toxins;
– a list of possible side effects, including blistering, pain, and scarring;
– when to seek medical advice prior to or during a use cycle;
– white or grey hair cannot be epilated;
– how to prepare the hair prior to use.
The instructions of appliances that use disposable parts or consumable materials shall list
these products and give advice on the safe disposal of them after use.
For appliance incorporating lasers, the instructions shall additionally provide specific
information about:
– the maximum laser output delivered to the skin;
– the embedded laser laser product class, wavelength/s, pulse duration, pulse repetition
rate, output radiant power or radiant energy;
2 2
– irradiance in W/m or radiant exposure in J/m for each output setting of the device;
– the anticipated effects of the laser radiation on the skin, for a Class 1C laser product
appliance that contains an embedded laser;
© IEC 2021
– repairs and, if applicable, recommended replacement components and accessories
compatible with the product.
For appliances incorporating ILS the instructions shall additionally provide specific information
about:
– the appliance optical output, wavelength range, pulse duration, pulse repetition rate,
output irradiance or radiance;
– repairs and, if applicable, recommended replacement components and accessories that
are compatible with the product, including lamps, timers, reflectors, and filters.
If symbol ISO 7000-1329 warning sign ISO 7010-W004, sign shown in Figure 101 or symbol
warning sign ISO 7010-W027 (2019-07) is used, its meaning shall be explained.
7.14 Addition:
The outer diameter of symbol ISO 7000-1329 height of the triangle in warning sign ISO 7010-
W004, height of the sign shown in Figure 101, and the height of the triangle in symbol warning
sign ISO 7010-W027 (2019-07) shall be at least 10 mm.
7.15 Addition:
Warnings on the housing shall be permanently fixed, legible, and clearly visible during use,
maintenance, and service. They shall be so positioned that they can be read without the
necessity for human exposure to laser radiation in excess of the AEL for Class 1 laser
product or optical radiation in excess of the AEL emission limits of the exempt group.
8 Protection against access to live parts
This clause of Part 1 is applicable.
9 Starting of motor-operated appliances
This clause of Part 1 is not applicable.
10 Power input and current
This clause of Part 1 is applicable.
11 Heating
This clause of Part 1 is applicable except as follows.
11.2 Addition:
Appliances intended to be used on a stand or attached to a support are placed to give the
most unfavourable results.
11.7 Replacement:
Appliances without a timer are operated
– for 30 min, for hand-held appliances and appliances with hand-held applicators;
– until steady conditions are established, for other appliances.
– 12 – IEC 60335-2-113:2016+AMD1:2021 CSV
© IEC 2021
Appliances incorporating a timer are operated in cycles until steady conditions are
established. Each cycle consists of the maximum operating time of the timer followed by
either the programmed rest period, or a minimum rest period of 5 s.
11.8 Addition:
An appliance intended to be operated when in contact with the skin shall be tested using the
artificial skin. All other appliances are tested in air. The maximum temperature rise of
appliance parts intended to be in contact with the human body in normal use shall not exceed
the following values:
– if of metals and liquids 26 K
– if of glass, porcelain and vitreous material 31 K
– if of moulded material, plastics, rubber and wood 35 K
The temperature rise of the artificial skin is not measured.
12 Void
13 Leakage current and electric strength at operating temperature
This clause of Part 1 is applicable except as follows:
13.1 Addition:
Compliance is also checked by the test of 13.101.
13.2 Addition:
For an applicator intended to make contact with the human body, the allowable limit for
leakage current is 0,1 mA.
13.101 The leakage current for the applicator intended to make contact with the human body
shall also be measured between the part in contact with the human body and the poles of the
supply with each supply conductor interrupted one at a time and shall not exceed 0,5 mA.
14 Transient overvoltages
This clause of Part 1 is applicable.
15 Moisture resistance
This clause of Part 1 is applicable.
16 Leakage current and electric strength
This clause of Part 1 is applicable.
17 Overload protection of transformers and associated circuits
This clause of Part 1 is applicable.
© IEC 2021
18 Endurance
This clause of Part 1 is applicable.
19 Abnormal operation
This clause of Part 1 is applicable except as follows.
19.13 Addition:
During and after the tests, if the appliance is operational, it shall comply with Clause 32.
20 Stability and mechanical hazards
This clause of Part 1 is applicable.
21 Mechanical strength
This clause of Part 1 is applicable except as follows.
21.1 Addition:
Hand-held appliances and hand-held parts of the appliance are also subjected to the test of
21.101.
21.101 The appliance is placed on a horizontal surface positioned 700 mm above a rigidly
supported hardwood board and operated while supplied at rated voltage.
It is pulled from the surface by its supply cord and allowed to drop freely. The test is carried
out five times, the appliance being placed on the horizontal surface in different positions likely
to occur.
The appliance shall not be damaged to such an extent that compliance with this standard is
impaired. In particular, the requirements of Clauses 8 and 29 shall be fulfilled.
21.102 The enclosure of a detachable power supply part used in a flexible cord shall have
adequate mechanical strength against crushing.
Compliance is checked by the following test.
The appliance is operated under the conditions of Clause 11 with the detachable power
supply part placed on the floor of the test corner.
After steady conditions are established, a compression force of 1 350 N is applied to the
detachable power supply part enclosure. The compression force is applied for one minute
using a flat surface 100 mm × 250 mm and repeated with the detachable power supply part
placed in all possible different orientations.
The detachable power supply part shall not be damaged to such an extent that compliance
with 8.1 and Clause 29 is impaired and it shall not emit flames or molten metal.
21.103 The enclosure of a detachable power supply part used in a flexible cord shall have
adequate mechanical strength against dropping.
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© IEC 2021
Compliance is checked by the following test.
The detachable power supply part is placed in a sling that is constructed by tying together
the four corners of a single layer of cheesecloth. The lowest point of the sling is suspended at
a height of 900 mm above a concrete or similar hard surface.
The detachable power supply part in the sling is dropped from a stationary position. The
test is carried out a total of five times with the detachable power supply part being
positioned so that it falls onto the concrete surface in five different orientations.
The detachable power supply part shall not be damaged to such an extent that compliance
with 8.1 and Clause 29 is impaired.
22 Construction
This clause of Part 1 is applicable except as follows.
22.7 Addition:
This requirement also applies to negative pressure.
22.101 Appliances incorporating rechargeable non-sealed batteries shall be ventilated.
Compliance is checked by inspection.
22.102 Appliances incorporating parts that are suspended or intended to be raised and
lowered over a person shall incorporate a safety device to prevent injury if the suspension
means fails or there is excessive travel of the part.
Compliance is checked by inspection and by manual test.
22.103 Foot-operated control devices shall be able to support the weight of a person.
Compliance is checked by applying to the foot-operated control device, in its position of
normal use, an actuating force of 1 350 N for 1 min. The force is applied over an area of
625 mm . There shall be no damage to the device that is likely to cause a hazard.
22.104 Foot-operated control devices and hand-held control devices shall not change their
control setting when inadvertently placed in an unintended position.
Compliance is checked by turning the device in all positions where the control device can be
activated or kept activated under the weight of the control and placing it on a supporting
surface. There shall not be any inadvertent change of control setting that is likely to cause a
hazard.
22.105 Appliances using vacuum or pressure aperture shall be constructed so that
– gas flow, by means of cooling gas supply, shall not exceed an output pressure of 20 kPa;
– the suction applicators or probes shall not induce a vacuum exceeding 75 kPa.
Compliance is checked by inspection and measurement.
22.106 Any appliance incorporating
– an embedded laser a laser product, other than a Class 1 laser product, Class 1M laser
product, Class 2 laser product, Class 2M laser product; or
© IEC 2021
– an ILS other than those classified as exempt group in 6.1.1 of IEC 62471:2006 or
classified as risk group 1 in 6.1.2 of IEC 62471:2006
shall give a visible, audible or tactile signal when the interlock system senses good contact
with the skin and enables the appliance for emission.
If a tactile signal is used, the indication of good contact shall be other than the sense of
pressure on the skin. An example of an acceptable tactile signal is vibration.
Compliance is checked by inspection and by functional tests.
22.107 If an appliance incorporates
– a laser, other than a Class 1 laser product, Class 1M laser product, Class 2 laser
product, Class 2M laser product, that emits above the AEL of a Class 1 laser product
for the skin in IEC 60825-1; or
– an ILS, other than those classified as exempt group in 6.1.1 of IEC 62471:2006 or
classified as risk group 1 in 6.1.2 of IEC 62471:2006, that emits above the AEL of
exempt group for the skin specified in 4.3.8 of IEC 62471:2006
– a laser product that emits above the AEL of a Class 3B laser product in IEC 60825-
1:2014; or
– an ILS classified as risk group 3 as defined in 6.1.4 of IEC 62471:2006 (continuous wave
light source) or in 6.2 of IEC 62471:2006 (pulsed light source),
it shall have means to assess the skin pigmentation level and means to adjust the output
according to the skin pigmentation level so that damage to the bulk tissue is avoided.
NOTE The means to assess the skin pigmentation level can be via a colour chart.
Means of assessing the pigmentation level is not required if the appliance is not capable of
damaging the bulk tissue of any skin type when set at the maximum output.
Compliance is checked by inspection. For devices without means to adjust the output, the
manufacturer shall supply a validation study on human skin showing that damage to the bulk
tissue does not occur. The study shall be a registered clinical study in accordance with good
clinical practice as described in ISO 14155.
If compliance relies on a programmable an electronic circuit that is programmable, the
software shall contain measures to control the fault/error conditions specified in Table R.1
and it is evaluated in accordance with the relevant requirements of Annex R.
22.108 Appliances incorporating an embedded laser a laser product other than a Class 1
laser product shall be equipped with an interlock system which is capable of detecting
whether good contact with the human skin is established.
If continuous action by the user is required to maintain the enabled status (for example an
activation button is continuously depressed) the appliance shall keep emitting, unless good
contact with the skin is lost.
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