SIST EN 60335-2-52:2003/A11:2011

Household and similar electrical appliances - Safety - Part 2-52: Particular requirements for oral hygiene appliances

This international standard deals with the safety of electric oral hygiene appliances for household and similar purposes, their rated voltage being not more than 250 V.

Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-52: Besondere Anforderungen für Mundpflegegeräte

Appareils électrodomestiques et analogues - Sécurité - Partie 2-52: Règles particulières pour les appareils d'hygiène buccale

Gospodinjski in podobni električni aparati - Varnost - 2-52. del: Posebne zahteve za aparate za ustno nego - Dodatek A11

Uporabljati ga je treba v povezavi z zadnjo izdajo standarda IEC 335-1 in njegovimi spremembami, določen pa je bil na podlagi tretje izdaje (1991) navedenega standarda. Uporabljajo se točke iz dela 1, razen za navedene zamenjave, izbrise, dodatke in spremembe. Uporablja se za električne aparate za ustno nego, katerih nazivna napetost ne presega 250 V. V največji možni meri obravnava splošne nevarnosti, ki jih predstavljajo aparati ter s katerimi se srečujejo osebe doma in v okolici doma.

General Information

• Status: Published
• Publication Date: 07-Apr-2011
• 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: 30-Mar-2011
• Due Date: 04-Jun-2011
• Completion Date: 08-Apr-2011
• Directive: 2006/95/EC - Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version)
• 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/392 - Mandate to CENELEC in the field of the Low Voltage Directive 73/23/EC
• Ref Project: EN 60335-2-52:2003/A11:2010 - Household and similar electrical appliances - Safety - Part 2-52: Particular requirements for oral hygiene appliances

Relations

• Amends: SIST EN 60335-2-52:2003 - Household and similar electrical appliances - Safety -- Part 2-52: Particular requirements for oral hygiene appliances
• Effective Date: 01-May-2011
• Corrected By: SIST EN 60335-2-52:2003/A11:2011/AC:2012 - Household and similar electrical appliances - Safety - Part 2-52: Particular requirements for oral hygiene appliances
• Effective Date: 01-Sep-2012

Overview

SIST EN 60335-2-52:2003/A11:2011 is a vital European standard specifically addressing the safety of household and similar electrical appliances designed for oral hygiene. This amendment to the original EN 60335-2-52:2003 standard provides updated, particular requirements for oral hygiene appliances such as electric toothbrushes and oral irrigators. Developed under the auspices of the European Committee for Electrotechnical Standardization (CENELEC), this standard ensures products meet rigorous safety benchmarks to protect all users, including vulnerable populations like children and the elderly.

The standard is applicable throughout Europe and forms a critical part of domestic safety regulations concerning body care electrical equipment. It focuses on minimizing risks like electric shock, mechanical hazards, and ingestion or choking dangers associated with oral hygiene appliances.

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Key Topics

• Scope and User Considerations
  The standard covers common hazards related to oral hygiene appliances in household and similar environments. It explicitly addresses the differentiated needs of various user groups, including:

  • Very young children (0–36 months) who require supervision.
  • Young children (over 36 months to under 8 years) needing close supervision for safe use.
  • Older children (8–14 years) who can use appliances safely after instruction.
  • Vulnerable and very vulnerable people with reduced physical, sensory, or mental capabilities.

• Safety and Construction Requirements

  • Appliances shall be designed to prevent ingestion or choking hazards, especially for vulnerable users.
  • Detachable brushes must either not pose a choking hazard or require tools to remove them.
  • Appliances must withstand corrosive effects from chemicals commonly used in oral hygiene devices.

• Marking and Instructions

  • Clear, legible instructions with minimum font size requirements (at least 4 mm capital letters) must be provided.
  • Devices controlling operation (on/off) require tactile, audible, or visual feedback to assure safe operation.
  • Specific usage instructions emphasizing child supervision, cleaning, maintenance, and correct use of oral irrigators with cold or warm water or manufacturer-specified solutions.

• Testing and Compliance Measures

  • Mechanical strength testing includes free-fall impact tests to simulate everyday use scenarios ensuring no critical damage occurs.
  • Protection against access to live parts is rigorously tested using IEC 61032 probes ensuring user safety.
  • Temperature rise limits on appliance surfaces are specified to prevent burns or discomfort.

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Applications

SIST EN 60335-2-52:2003/A11:2011 applies primarily to manufacturers, testing laboratories, and regulators involved in the design, production, and certification of oral hygiene electrical appliances. Key applications include:

• Product Development:
  Guidance for engineering safer electric toothbrushes, oral irrigators, and similar devices.

• Safety Compliance:
  Ensures products meet European safety legislation requirements before market release.

• Quality Assurance:
  Implementation in quality control processes to test mechanical durability and electrical safety.

• User Guidance and Labeling:
  Helps manufacturers create clear safety instructions and user interfaces suitable for all ages and vulnerable groups.

• Risk Mitigation:
  Protects consumers, especially children and vulnerable individuals, from hazards such as electric shock, choking, and mechanical injury.

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Related Standards

• EN ISO 20127 – Dentistry - Powered toothbrushes - General requirements and test methods
  Complementary standard referenced for testing protocols specific to powered toothbrush components.

• IEC 62079 – Preparation of instructions - Structuring, content, and presentation
  Provides guidelines to enhance the clarity, legibility, and effectiveness of appliance instructions for safe use.

• ISO/IEC Guide 50 – Safety aspects - Guidelines for child safety
  Supports the inclusion of child safety considerations in product design and standards development.

• ISO/IEC Guide 71 – Guidelines for addressing needs of older persons and persons with disabilities
  Ensures standardization efforts incorporate safety and usability for vulnerable user groups.

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Keywords: oral hygiene appliance safety, EN 60335-2-52 amendment, electric toothbrush safety, oral irrigator standard, household electrical appliance safety, vulnerable user protection, child safety standards, domestic electrical equipment, CENELEC electrotechnical standards.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2011
*RVSRGLQMVNLLQSRGREQLHOHNWULþQLDSDUDWL9DUQRVWGHO3RVHEQH]DKWHYH
]DDSDUDWH]DXVWQRQHJR'RGDWHN$
Household and similar electrical appliances - Safety - Part 2-52: Particular requirements
for oral hygiene appliances
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-52:
Besondere Anforderungen für Mundpflegegeräte
Appareils électrodomestiques et analogues - Sécurité - Partie 2-52: Règles particulières
pour les appareils d'hygiène buccale
Ta slovenski standard je istoveten z: EN 60335-2-52:2003/A11:2010
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 60335-2-52/A11
NORME EUROPÉENNE
May 2010
EUROPÄISCHE NORM
ICS 97.170
English version
Household and similar electrical appliances -
Safety -
Part 2-52: Particular requirements for oral hygiene appliances

Appareils électrodomestiques  Sicherheit elektrischer Geräte
et analogues - Sécurité - für den Hausgebrauch
Partie 2-52: Règles particulières und ähnliche Zwecke -
pour les appareils d'hygiène buccale Teil 2-52: Besondere Anforderungen
für Mundpflegegeräte
This amendment A11 modifies the European Standard EN 60335-2-52:2003; it was approved by CENELEC on
2010-04-14. 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 Central Secretariat 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
Central Secretariat 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60335-2-52:2003/A11:2010 E

Foreword
A proposal to amend EN 60335-2-52:2003, document CLC/TC 61(SEC)1688, was discussed during the
Brussels meeting of CENELEC TC 61 in June 2009, when it was decided to submit a draft for an
amendment to the Unique Acceptance Procedure.
The draft was circulated in June 2009 and was approved by CENELEC as amendment A11 to
EN 60335-2-52:2003 on 2010-04-14.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates are applicable:
– latest date by which the amendment has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2011-05-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2013-04-14
This amendment supplements or modifies the corresponding clauses of EN 60335-2-52:2003.
There are no special national conditions causing a deviation from this amendment.
There are no national deviations from this amendment.
____________
– 3 – EN 60335-2-52:2003/A11:2010
1 Scope
Replace the third paragraph including the two dashed items by the following:
As far as is practicable, this standard deals with the common hazards presented by appliances that are
encountered by all persons in household and similar environments
However, in general, it does not take into account:
– children playing with the appliance,
– the use of toothbrushes and oral irrigators by very young children without supervision
– the use of oral irrigators by very young children
– user maintenance by children, including cleaning the appliance.
It is recognized that very vulnerable people may have needs beyond the level addressed in this
standard.
2 Normative references
Add the following reference:
EN ISO 20127, Dentistry -Powered toothbrushes - General requirements and test methods
3 Definitions
3.6.3
accessible part
Modification:
Insert “and probe 18” after “test probe B”.
Add the following new definitions:
3.Z101
children
young persons comprising very young children, young children and older children
NOTE Children are not expected to perform cleaning or user maintenance of the appliance.
3.Z102
very young children
young persons aged from 0 up to and including 36 months
NOTE Very young children are not expected to use toothbrushes safely unless continuous supervision is given and they are not
expected to use oral irrigators.
3.Z103
young children
young persons older than 36 months and younger than 8 years
NOTE Young children are not expected to use oral irrigators safely unless continuous supervision is given.

3.Z104
older children
young persons aged from 8 years up to and including 14 years
NOTE Older children can use appliances safely after they have been given appropriate supervision or instruction concerning use
of the appliance.
3.Z105
vulnerable people
persons having reduced physical, sensory or mental capabilities (e.g. partially disabled, elderly having
some reduction in their physical and mental capabilities), or lack of experience and knowledge (e.g. older
children)
NOTE Vulnerable people can use appliances safely after they have been given appropriate supervision or instruction concerning
use of the appliance.
3.Z106
very vulnerable people
persons having very extensive and complex disabilities
NOTE Very vulnerable people are not expected to use appliances safely unless continuous supervision is given or appliances
are adapted accordingly with arrangements beyond the scope of this standard.
3.Z107
use of the appliance
all actions required to have the appliance perform its intended function, such as plugging in, switching on,
using, regulating, cleaning the appliance or performing user maintenance
7 Marking and instructions
Add:
7.10 Addition:
De
...