EN 1400:2013+A2:2018
(Main)Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and product information for soothers.
This European Standard is applicable to products that resemble or function as a soother. Some soothers may be marketed with other functions. This standard is applicable to these products (some examples are given in Annex C).
This European Standard does not apply to products designed for specialist clinical medical applications, e.g. those relating to Pierre-Robin Syndrome or premature babies (see Annex C).
The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats are included in all parts of EN 14350 [2], [3].
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Sicherheitstechnische Anforderungen und Prüfverfahren
Diese Europäische Norm legt Sicherheitsanforderungen hinsichtlich der Werkstoffe, der Gestaltung, der Leistungsmerkmale, Verpackung und der Produktinformationen für Schnuller fest.
Diese Europäische Norm gilt für Produkte, die das Aussehen eines Schnullers haben oder die als Schnuller dienen. Einige Schnuller können mit weiteren Funktionen verkauft werden. Diese Norm gilt auch für solche Produkte (einige Beispiel dafür sind in Anhang C angegeben).
Diese Europäische Norm gilt nicht für Produkte für besondere klinische medizinische Anwendungen, z. B. beim Pierre-Robin-Syndrom oder bei Frühgeborenen (siehe Anhang C).
Die Norm gilt nicht für Ernährungssauger. Sicherheitsanforderungen und Prüfverfahren für Ernährungs-sauger sind in EN 14350 [2], [3] festgelegt.
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Exigences de sécurité et méthodes d'essai
La présente Norme européenne spécifie les exigences de sécurité relatives aux matériaux constitutifs, à la construction, à la performance, à l’emballage et aux informations relatives au produit des sucettes.
La présente Norme européenne est applicable aux produits qui ressemblent à une sucette ou qui fonctionnent de la même façon. Certaines sucettes mises sur le marché peuvent avoir d’autres fonctions. La norme s’applique également à ces produits (l’Annexe C donne des exemples).
La présente Norme européenne n’est pas applicable aux produits destinés à des applications médicales cliniques spécialisées, tels que ceux destinés aux nourrissons prématurés ou présentant le Syndrome de Pierre Robin (voir l’Annexe C).
La présente norme ne s’applique pas aux tétines de biberons. Les exigences de sécurité et méthodes d’essai applicables aux tétines de biberons sont incluses dans toutes les parties de l’EN 14350 [2], [3].
Izdelki za otroke - Dude za dojenčke in mlajše otroke - Varnostne zahteve in preskusne metode (z dopolnili do vključno A2)
Ta evropski standard določa varnostne zahteve v zvezi z materiali, sestavo, lastnostmi, pakiranjem in informacijami o izdelku za dude.
Ta evropski standard se uporablja za izdelke, ki so podobni dudam ali delujejo kot dude. Nekatere dude se lahko oglašujejo z drugimi funkcijami. Ta standard velja za te izdelke (nekateri primeri so podani v Dodatku C).
Ta evropski standard se ne uporablja za izdelke, namenjene specialistični klinični medicinski uporabi, npr. v zvezi s Pierre-Robinovim sindromom ali nedonošenčki (glej Dodatek C).
Ta standard se ne uporablja za cuclje za hranjenje. Varnostne zahteve in preskusne metode za cuclje za hranjenje so vključene v vse dele standarda EN 14350 [2], [3].
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2018
Nadomešča:
SIST EN 1400:2013+A1:2014
Izdelki za otroke - Dude za dojenčke in mlajše otroke - Varnostne zahteve in
preskusne metode (z dopolnili do vključno A2)
Child use and care articles - Soothers for babies and young children - Safety
requirements and test methods
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder -
Sicherheitstechnische Anforderungen und Prüfverfahren
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Exigences de
sécurité et méthodes d'essai
Ta slovenski standard je istoveten z: EN 1400:2013+A2:2018
ICS:
97.190 Otroška oprema Equipment for children
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 1400:2013+A2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2018
EUROPÄISCHE NORM
ICS 97.190 Supersedes EN 1400:2013+A1:2014
English Version
Child use and care articles - Soothers for babies and young
children - Safety requirements and test methods
Articles de puériculture - Sucettes pour nourrissons et Artikel für Säuglinge und Kleinkinder - Schnuller für
jeunes enfants - Exigences de sécurité et méthodes Säuglinge und Kleinkinder - Sicherheitstechnische
d'essai Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 25 February 2014 and includes Amendment 2 approved by CEN on 23 April
2018.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 9 January 2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISA T IO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1400:2013+A2:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Description of a soother . 7
5 Test equipment . 11
6 General . 18
7 Printing and decals . 21
8 Construction properties and tests . 21
9 Mechanical properties . 35
10 Chemical requirements and test methods . 43
11 Teat protectors . 51
12 Consumer packaging . 53
13 Product information . 53
14 Test report . 55
Annex A (normative) Warnings . 57
Annex B (informative) Rationale . 61
Annex C (informative) Information for products resembling a soother . 73
Annex D (informative) Some examples of suitable fixing devices . 75
Annex E (informative) Soothers — Assessment of compliance with standard — Sampling
plan and compliance levels for freshly manufactured samples . 78
Annex F (informative) A suitable HPLC apparatus and method for determination of 2-
Mercaptobenzothiazole (MBT) and antioxidants BHT, 2246, Cyanox 425, Wingstay L
and Irganox 1520 . 79
Annex G (informative) Graphical representation for determining puncture resistance of a
teat . 83
Annex H (informative) A–deviations . 84
Bibliography . 85
European foreword
This document (EN 1400:2013+A2:2018) has been prepared by Technical Committee CEN/TC 252
“Child care articles”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2019, and conflicting national standards shall
be withdrawn at the latest by March 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document includes Amendment 1, approved by CEN on 2014-02-25 and Amendment 2, approved
by CEN on 2018-04-23.
This document supersedes #EN 1400:2013+A1:2014$.
The start and finish of text introduced or altered by amendment is indicated in the text by tags !"
and #$.
This document has been prepared under a mandate (M/264) given to CEN by the European
Commission and the European Free Trade Association.
This standard is linked to the General Product Safety Directive (GPSD) but no Annex ZA is needed
because GPSD is not a New Approach Directive and does not include Essential Requirements to which
such an annex should refer.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Introduction
Soothers are widely used throughout Europe to satisfy non-nutritive sucking needs and to pacify
children.
They are designed to be in the mouths of babies and young children for long periods. Accidents, some of
which have been fatal, have occurred in the past and a prime purpose of this standard is to reduce the
risk of accidents occurring in the future. It is stressed that this European Standard cannot eliminate all
possible risks to babies and young children using such a product and that parental or guardian control
is of paramount importance. It is essential that all warnings and instructions specified in this standard
are given clearly by the manufacturer, to allow the consumer to ensure that the soother is used
correctly and safely.
This European Standard harmonises minimum safety requirements and test methods for soothers. Most
of the provisions have been taken from other existing national and European Standards.
It is recommended that manufacturers and suppliers operate to EN ISO 9001, the standard for quality
management systems [1]. It is also recommended that laboratories operate to ISO/IEC 17025, General
requirements for the competence of testing and calibration laboratories [4].
In addition, it is recognised that some organisations require reference testing. A suggested sampling
plan and compliance levels for freshly manufactured soothers are provided in Annex E (informative).
This procedure can be used as a voluntary type approval procedure.
Latex protein allergy risk has not been included in this standard. Nevertheless, provision for packaging
information for soothers containing natural rubber has been made in this standard. There is no
published information that sensitisation is caused by soother teats. In addition, there is an extremely
low incidence of latex protein allergy among young children and babies. However, the issue of
subsequent allergic reaction from rubber teats will be reconsidered when further information becomes
available.
Phthalates have not been included in this standard because the use of phthalates in childcare articles is
restricted by Annex XVII of REACH Regulation [5].
A normative annex has been included which contains translations of warning phrases into the main
European languages.
# Since the publication of EN 1400:2013+A1:2014 it has come to the attention of the Technical
Committee that some of the TDI's used to calculate the limits of a certain number of element migration
from soothers are out of date. During the drafting of this amendment the Technical committee reviewed
all the previous sources of TDI's to ascertain the current state of knowledge.
The migration limits for Arsenic, Barium, and Nickel have been changed to reflect the latest information.
In addition migration limits for Chromium VI and Organic Tin have been added.
The Technical Committee has also included a requirement for Bisphenol A (BPA) in soothers based on
the most recent TDI from the 2015 EFSA Opinion and an A-Deviation from France.$
1 Scope
This European Standard specifies safety requirements relating to the materials, construction,
performance, packaging and product information for soothers.
This European Standard is applicable to products that resemble or function as a soother. Some soothers
may be marketed with other functions. This standard is applicable to these products (some examples
are given in Annex C).
This European Standard does not apply to products designed for specialist clinical medical applications,
e.g. those relating to Pierre-Robin Syndrome or premature babies (see Annex C).
The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats
are included in all parts of EN 14350 [2], [3].
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
DIN 53160-1, Determination of the colourfastness of articles for common use — Part 1: Test with artificial
saliva
EN 71-1, Safety of toys — Part 1: Mechanical and physical properties
EN 71-3, Safety of toys — Part 3: Migration of certain elements
EN 71-11:2005, Safety of toys — Part 11: Organic chemical compounds — Methods of analysis
EN 12868, Child use and care articles — Methods for determining the release of N-Nitrosamines and N-
Nitrosatable substances from elastomer or rubber teats and soothers
EN 20105-A03, Textiles — Tests for colour fastness — Part A03: Grey scale for assessing staining
(ISO 105-A03)
EN ISO 1302, Geometrical Product Specifications (GPS) — Indication of surface texture in technical
product documentation (ISO 1302)
EN ISO 3696, Water for analytical laboratory use — Specification and test methods (ISO 3696)
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing or heat resistance tests
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
soother
article which includes a teat and which is intended to satisfy the non-nutr
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Sicherheitstechnische Anforderungen und PrüfverfahrenArticles de puériculture - Sucettes pour nourrissons et jeunes enfants - Exigences de sécurité et méthodes d'essaiChild use and care articles - Soothers for babies and young children - Safety requirements and test methods97.190Otroška opremaEquipment for childrenICS:Ta slovenski standard je istoveten z:EN 1400:2013+A2:2018SIST EN 1400:2013+A2:2018en,fr,de01-oktober-2018SIST EN 1400:2013+A2:2018SLOVENSKI
STANDARDSIST EN 1400:2013+A1:20141DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1400:2013+A2
September 2018 ICS 97.190
English Version
Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Exigences de sécurité et méthodes d'essai
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Sicherheitstechnische Anforderungen und Prüfverfahren This European Standard was approved by CEN on 25 February 2014 and includes Amendment 1, approved by CEN on 2014-02-25 and Amendment 2, approved by CEN on 2018-04-23.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels © 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1400:2013+A2:2018 E SIST EN 1400:2013+A2:2018
Warnings . 57 Annex B (informative)
Rationale . 61 Annex C (informative)
Information for products resembling a soother . 73 Annex D (informative)
Some examples of suitable fixing devices . 75 Annex E (informative)
Soothers — Assessment of compliance with standard — Sampling plan and compliance levels for freshly manufactured samples . 78 Annex F (informative)
A suitable HPLC apparatus and method for determination of 2-Mercaptobenzothiazole (MBT) and antioxidants BHT, 2246, Cyanox 425, Wingstay L and Irganox 1520 . 79 Annex G (informative)
Graphical representation for determining puncture resistance of a teat . 83 Annex H (informative)
A–deviations . 84 Bibliography . 85 SIST EN 1400:2013+A2:2018
...
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