SIST EN IEC 60335-2-113:2023/A11:2023

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

This European 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

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

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

Gospodinjski in podobni električni aparati - Varnost - 2-113. del: Posebne zahteve za kozmetične in lepotne aparate z laserji in viri močne svetlobe - Dopolnilo A11

General Information

• Status: Published
• Publication Date: 23-May-2023
• ICS: 13.120 - Domestic safety
• ICS: 97.170 - Body care equipment
• Technical Committee: VGA - Safety of household and similar electrical appliances
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 17-May-2023
• Due Date: 22-Jul-2023
• Completion Date: 24-May-2023
• Directive: 2014/35/EU - Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
• Mandate: M/511 - Mandate to CEN, CENELEC and ETSI relating to harmonised standards in the field of the Low Voltage Directive
• Ref Project: EN IEC 60335-2-113:2023/A11:2023 - Household and similar electrical appliances - Safety - Part 2-113: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources

Relations

• Amends: SIST EN IEC 60335-2-113:2023 - 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)
• Effective Date: 09-Feb-2021

Overview

EN IEC 60335-2-113:2023/A11:2023 is a CENELEC amendment to the European standard for household and similar electrical appliances - specifically the particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources. It applies to appliances intended to operate in contact with skin at a rated voltage not exceeding 250 V. Amendment A11 updates scope, definitions, marking, test procedures and safety requirements to reflect photobiological risks, interlock behaviour and user instructions for devices such as home-use laser and intense pulsed light (IPL) hair-removal or cosmetic devices.

Key Topics and Requirements

• Scope and user restrictions: Appliances covered are for adults; they are not intended for use by children nor to be applied to children's skin. Persons with reduced capabilities may use them only with supervision or instruction.
• Photobiological safety: Cross-references and evaluation requirements from EN 62471 (photobiological safety of lamps and lamp systems) are incorporated, including guidance for pulsed sources (see EN 62471 clauses 6.1.1 and 6.2).
• Laser safety classification: Normative references include IEC 60825-1 for laser product classification and requirements; the amendment updates symbols and warning practices (ISO 7010-W004).
• Marking and instructions: Updated requirements for user manuals and marking - e.g., inclusion of warnings about jewellery and piercings, side-effect listings if instructions are not followed, and mandated safety symbols with minimum dimensions (triangle height ≥ 10 mm).
• Interlocks and emission control: Test modifications require interlock systems to prevent resumed emission after re-application during an interlock test (re-applying the applicator after 10 s shall not restart emission).
• Definitions and operational notes: Clarifies that during intended operation irradiance or radiant exposure may exceed skin MPE when in contact with skin/non-ocular tissue, with a specific note added to the terms.
• Software and construction: Annex R (software evaluation) and modifications to construction and mechanical strength clauses are included to ensure compliance with critical clauses (e.g., Clause 19, 22.107, 22.108).

Applications and Who Uses This Standard

• Manufacturers and product designers of home-use laser/IPL cosmetic devices - for safe design, labelling and instructions.
• Test laboratories and conformity assessment bodies - for type testing, interlock and photobiological evaluations.
• Regulatory and compliance teams, notified bodies, importers - to demonstrate conformity with European safety requirements.
• Safety engineers and QA teams - to integrate safety controls, warnings and software assessment into product development.

Related Standards

• EN IEC 60335-2-113:2023 (Part 2 main document)
• EN 60335-1 (Part 1 general requirements)
• EN 62471 (Photobiological safety of lamps and lamp systems)
• EN 60825-1 / IEC 60825-1 (Safety of laser products)
• EN ISO 7010 (Safety symbols)
• EN ISO 14155 (clinical investigation of medical devices) - referenced for clinical aspects

Keywords: EN IEC 60335-2-113:2023/A11:2023, cosmetic and beauty care appliances, laser safety, IPL devices, household appliance safety, CENELEC, photobiological safety, EN 62471.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2023
Gospodinjski in podobni električni aparati - Varnost - 2-113. del: Posebne zahteve
za kozmetične in lepotne aparate z laserji in viri močne svetlobe - Dopolnilo A11
Household and similar electrical appliances - Safety - Part 2-113: Particular requirements
for cosmetic and beauty care appliances incorporating lasers and intense light sources
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-113:
Besondere Anforderungen für Kosmetik- und Schönheitspflegegeräte mit eingebauten
Lasern und Intensivlichtquellen
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
Ta slovenski standard je istoveten z: EN IEC 60335-2-113:2023/A11:2023
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-
113:2023/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2023
ICS 13.120; 97.170
English Version
Household and similar electrical appliances - Safety - Part 2-
113: Particular requirements for cosmetic and beauty care
appliances incorporating lasers and intense light sources
Appareils électrodomestiques et analogues - Sécurité - Sicherheit elektrischer Geräte für den Hausgebrauch und
Partie 2-113: Exigences particulières pour les appareils ähnliche Zwecke - Teil 2-113: Besondere Anforderungen
destinés aux soins cosmétiques et esthétiques comportant für Kosmetik- und Schönheitspflegegeräte mit eingebauten
des lasers et des sources de lumière de forte intensité Lasern und Intensivlichtquellen
This amendment A11 modifies the European Standard EN IEC 60335-2-113:2023; it 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
amendment 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 amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status
as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60335-2-113:2023/A11:2023 E

European foreword
This document (EN IEC 60335-2-113:2023/A11:2023) has been prepared by CLC/TC 61, “Safety of
household and similar electrical appliances”.
The following dates are fixed:
• latest date by which this document has to be (dop) 2024-03-01
implemented at national level by publication of an
identical national standard or by endorsement
• latest date by which the national standards (dow) 2026-03-01
conflicting with this document have to be
withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document is read in conjunction with EN IEC 60335-2-113:2023.
The numbering system for European clauses, subclauses, notes, tables, figures and annexes that are
additional to those in the IEC standard are prefixed with the letter “Z”.
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.
1 Modification to the Introduction
Addition:
This European amendment A11 supplements or modifies the corresponding clauses of the standards
below:
— EN 60335-1:2012+A11:2014+ A13:2017+A1:2019+A14:2019+A2:2019+A15:2021+A16:—
(Part 1)
— EN IEC 60335-2-113:2023 (Part 2)
2 Modification to Clause 1, “Scope”
Delete the fourth paragraph.
Replace the sixth paragraph, including the two dashed items, starting with ”As far as is practicable,…” by
the following:
This document deals with the reasonably foreseeable hazards presented by appliances that are
encountered by all persons.
However, in general, it does not take into account children playing with the appliance. Appliances covered
by this document are not intended to be used by children nor applied on the skin of children.
It is recognized that very vulnerable people can have needs beyond the level addressed in this
document.
3 Modification to Clause 3, “Terms and definitions”
3.102
Add the following Note 1 to entry:
Note 1 to entry: During operation and when in contact with skin or non-ocular tissue, irradiance or radiant exposure
levels may exceed the skin MPE as necessary for the intended use.
4 Modification to Clause 5, “General conditions for the tests”
5.101
...