EN 1400:2013
(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 Ernährungssauger sind in EN 14350 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 (voir l’Annexe C).
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).
NOTE Il est recommandé que les sucettes exclues du domaine d’application de la présente Norme européenne satisfassent à ces exigences lorsqu’elles sont applicables.
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 l’EN 14350.
Izdelki za otroke - Dude za dojenčke in mlajše otroke - Varnostne zahteve in preskusne metode
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 se uporablja za te izdelke. Ta evropski standard se ne uporablja za izdelke, namenjene specialistični klinični medicinski uporabi, npr. v zvezi s Pierre-Robinovim sindromom ali prezgodaj rojenimi nedonošenčki. Ta standard se ne uporablja za cuclje za hranjenje. Varnostne zahteve in preskusne metode za cuclje za hranjenje so vključene v standard EN 14350.
General Information
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Standards Content (Sample)
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 PrüfmethodenArticles 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 1400:2013SIST EN 1400:2013en,fr,de01-maj-2013SIST EN 1400:2013SLOVENSKI
STANDARDSIST EN 1400-3:2003SIST EN 1400-2:2003SIST EN 1400-1:20031DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1400
March 2013 ICS 97.190 Supersedes EN 1400-1:2002, EN 1400-2:2002, EN 1400-3:2002English 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 12 January 2013.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1400:2013: ESIST EN 1400:2013
Warnings . 55 Annex B (informative)
Rationale . 60 Annex C (informative)
Information for products resembling a soother . 71 Annex D (informative)
Some examples of suitable fixing devices . 73 Annex E (informative)
Soothers — Assessment of compliance with standard — Sampling plan and compliance levels for freshly manufactured samples . 76 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 . 77 Annex G (informative)
Graphical representation for determining puncture resistance of a teat . 80 Annex H (informative)
A–deviations . 81 Bibliography. 82 SIST EN 1400:2013
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. SIST EN 1400:2013
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-nutritive sucking need of children Note 1 to entry: Soothers are also known as pacifiers or babies' dummies. 3.2 teat part of the soother designed to be placed in the mouth SIST EN 1400:2013
structure positioned adjacent to or on the shield to facilitate handling of the soother Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached to the shield or plug Note 2 to entry: See Figure 1. 3.5 knob structure positioned adjacent to or on the shield to facilitate gripping of the soother Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached to the shield or plug. Note 2 to entry: See Figure 2. 3.6 plug device located within the neck of the teat that secures the teat to the shield Note 1 to entry: See Figure 3. 3.7 cover device that prevents open access to the plug Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached to the shield or plug. Note 2 to entry: See Figure 3. 3.8 ventilation hole (see B.7) any shape of hole in the shield or teat protector that is large enough to allow sufficient passage of air to sustain life Note 1 to entry: See also 8.4.1 and 11.3.1. 3.9 teat protector device that can be attached to and detached from the soother to cover the teat 3.10 outer packaging any packaging used for storage of the product by a retailer, not including the packaging intended for the consumer 3.11 major axis of the soother ma
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