SIST EN 1400-1:2003
(Main)Child use and care articles - Soothers for babies and young children - Part 1: General safety requirements and product information
Child use and care articles - Soothers for babies and young children - Part 1: General safety requirements and product information
This part of this European Standard specifies general safety requirements relating to the materials, construction, packaging and labelling of soothers. It includes also requirements relating to the instructions for use.
This European Standard is applicable to products that resemble or function as a soother unless they are being marketed as medical devices.
This European Standard does not apply to products designed for specialist medical applications, e. g., those relating to Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex (see Annex A).
NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied.
The standard is not applicable to feeding teats.
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Teil 1 : Allgemeine Sicherheitstechnische Anforderungen und Produktinformationen
Dieser Teil dieser Europäischen Norm legt allgemeine Sicherheitsanforderungen hinsichtlich der Materialien, der Gestaltung, Verpackung und Kennzeichnung von Schnullern fest. Er enthält auch Anforderungen hinsichtlich der Gebrauchsanweisungen.
Diese Europäische Norm gilt für alle Produkte, die einem Schnuller ähnlich sind oder die als Schnuller dienen, ausgenommen solche, die zu medizinischen Zwecken abgegeben werden.
Diese Norm gilt nicht für Produkte für besondere medizinische Anwendungen oder den Einsatz unter medizinischer Aufsicht, z. B. beim Pierre-Robin-Syndrom oder bei Frühgeborenen. Diese Sonderfälle werden in einem informativen Anhang beschrieben (siehe Anhang A).
ANMERKUNG Es wird empfohlen, dass Schnuller, die vom Anwendungsbereich dieser Europäischen Norm ausgenommen sind, jene Anforderungen erfüllen sollten, die auf sie anwendbar sind.
Die Norm gilt nicht für Ernährungssauger ).
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Partie 1 : Exigences générales et informations relatives au produit
La présente partie de cette Norme européenne fixe les exigences de sécurité générales relatives aux matériaux constitutifs, a la construction, a l'emballage et a l'étiquetage des sucettes. Elle comprend également des exigences concernant le mode d'emploi.
La présente Norme européenne est applicable aux produits qui ressemblent a une sucette ou qui fonctionnent de la meme façon, excepté ceux qui sont mis sur le marché en tant que dispositifs médicaux.
La présente Norme européenne n'est pas applicable aux produits destinés a des applications médicales spécialisées, tels que ceux destinés aux nourrissons prématurés ou présentant le Syndrome de Robin. Ces cas particuliers sont décrits dans une annexe informative (voir annexe A).
NOTE Il est recommandé que les sucettes exclues du domaine d'application de la présente Norme européenne satisfassent aux exigences qui leur sont applicables.
La présente norme ne s'applique pas aux tétines de biberons ).
Izdelki za otroke - Dude za dojenčke in malčke - 1. del: Splošne varnostne zahteve in informacije o izdelkih
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Child use and care articles - Soothers for babies and young children - Part 1: General safety requirements and product informationArticles de puériculture - Sucettes pour nourrissons et jeunes enfants - Partie 1 : Exigences générales et informations relatives au produitArtikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Teil 1 : Allgemeine Sicherheitstechnische Anforderungen und ProduktinformationenTa slovenski standard je istoveten z:EN 1400-1:2002SIST EN 1400-1:2003en97.190ICS:SLOVENSKI
STANDARDSIST EN 1400-1:200301-maj-2003
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1400-1September 2002ICS 97.190English versionChild use and care articles - Soothers for babies and youngchildren - Part 1: General safety requirements and productinformationArticles de puériculture - Sucettes pour nourrissons etjeunes enfants - Partie 1 : Exigences générales etinformations relatives au produitArtikel für Säuglinge und Kleinkinder - Schnuller fürSäuglinge und Kleinkinder - Teil 1 : AllgemeineSicherheitstechnische Anforderungen undProduktinformationenThis European Standard was approved by CEN on 28 July 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1400-1:2002 E
EN 1400-1:2002 (E)2ContentspageForeword.3Introduction.41Scope.52Normative references.53Terms and definitions.54Description of a soother.65Requirements and test methods.105.1Materials.105.2Construction.116Consumer packaging.237Product information.237.1General.237.2Purchase information.237.3Instructions for use.23Annex A (informative)
Information for medical devices.25A.1 Resemble a soother but no other function.25A.2 Resemble a soother but having another minor function.25A.3 Resemble a soother but having another major function.25A.4 Specialised applications.25A.5 Medical devices.26Bibliography.27
EN 1400-1:2002 (E)3ForewordThis document EN 1400-1:2002 has been prepared by Technical Committee CEN/TC 252 "Child use and carearticles", 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 orby endorsement, at the latest by March 2003, and conflicting national standards shall be withdrawn at the latest byMarch 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association.This European Standard EN 1400 “Child use and care articles – Soothers for babies and young children” consistsof the following parts:— Part 1: General safety requirements and product information— Part 2: Mechanical requirements and tests— Part 3: Chemical requirements and testsThis part of this European Standard contains one annex:— annex A (informative) Information for medical devicesAccording to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.
EN 1400-1:2002 (E)4IntroductionSoothers 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 whichhave been fatal, have occurred in the past and a prime purpose of this standard is to reduce the risk of accidentsoccurring in the future. It is stressed that this European Standard cannot eliminate all possible risks to babies andyoung children using such a product and that parental or guardian control is of paramount importance. It isessential that all warnings and instructions specified in this standard are given clearly by the manufacturer, to allowthe consumer to ensure that the soother is used correctly and safely.This European Standard for soothers for babies and young children consists of the following parts:-Part 1:General safety requirements and product information-Part 2:Mechanical requirements and tests-Part 3:Chemical requirements and testsThe complete European Standard harmonises for the first time minimum safety requirements and test methods forsoothers. Most of the provisions have been taken from other existing national and European Standards and forthese provisions the Technical Committee has relied on previous validation.It is not permitted to claim compliance with individual parts of this standard. Any claim relates to all published parts.It is recommended that manufacturers and suppliers operate to EN ISO 9000 series standards for qualitymanagement systems.In addition it is recognised that some organisations require reference testing. A suggested sampling plan andcompliance levels for freshly manufactured soothers are provided in Part 2, annex B (informative). This procedurecan be used as a voluntary type approval procedure.It is noted that all plastic components are regulated by the Commission Directive 90/128/EEC relating to plasticmaterials and articles intended to come into contact with foodstuffs.NOTEIt is also noted that the release of N-nitrosamines and N-nitrosatables substances from elastomer or rubber teatsand soothers is controlled by the provisions of Commission Directive 93/11/EEC.
EN 1400-1:2002 (E)51 ScopeThis part of this European Standard specifies general safety requirements relating to the materials, construction,packaging and labelling of soothers. It includes also requirements relating to the instructions for use.This European Standard is applicable to products that resemble or function as a soother unless they are beingmarketed as medical devices.This European Standard does not apply to products designed for specialist medical applications, e.g., thoserelating to Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex(see annex A).NOTEIt is recommended that soothers excluded from the scope of this European Standard should meet thoserequirements that can be applied.The standard is not applicable to feeding teats.12 Normative referencesThis European Standard incorporates, by dated or undated references, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 1400-2,Child use and care articles - Soothers for babies and young children - Part 2: Mechanicalrequirements and tests.EN 1400-3,Child use and care articles - Soothers for babies and young children - Part3: Chemical requirementsand tests.3 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1sootherarticle intended for satisfying the non-nutritive sucking need of childrenNOTESoothers are also known as pacifiers or babies' dummies.3.2teatflexible nipple which is the part of the soother designed to be placed in the mouth3.3shieldstructure positioned at the rear of the teat to reduce the likelihood of the soother being drawn entirely into thechild's mouth
1 A standard for safety requirements and test methods for drinking equipment is in preparation.
EN 1400-1:2002 (E)63.4ring or knobstructure positioned adjacent to or on the shield to facilitate handling of the sootherNOTEThe ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached tothe shield or plug.3.5plugdevice located within the neck of the teat that secures the teat to the shield3.6coverdevice that prevents open access to the plug3.7ventilation holesholes in the shield of a soother which provide an air passage through which a child can breath, should the sootherbecome accidentally lodged in the mouth. The holes also reduce the risk of the soother being sucked into thepharynx through the generation of negative pressure4 Description of a sootherA soother as shown in Figures 1, 2, 3 and 4 can consist of:a) teat (1) d) plug (4)b) shield (2) e) cover (5)c) ring (3) f) knob (6)NOTESimilar components are marked with the same number in Figures 1 to 4.
EN 1400-1:2002 (E)7Key1 Teat2 Shield3 Ring4 Plug5 Cover7 Sucking face of shieldFigure 1 - Example of a soother with ring
EN 1400-1:2002 (E)8Key1 Teat2 Shield4 Plug6 Knob7 Sucking face of shieldFigure 2 - Example of a soother with knob
EN 1400-1:2002 (E)9Key1 Teat2 Shield4 Plug5 Cover7 Sucking face of shieldFigure 3 - Example of a soother with plug and cover
EN 1400-1:2002 (E)10Key1 Teat2 Shield4 Plug5 Cover6 Knob7 Sucking face of shieldFigure 4 - Example of a soother with a combined plug, cover and knob5 Requirements and test methods5.1 MaterialsFor manufacturing of the different soother parts only such materials shall be used which comply with therequirements set forth in EN 1400-2 and EN 1400-3.If used, imprinted and moulded decorations shall be applied only to the parts of the soother behind the sucking faceof the shield (see Figure 1 to 4). Adhesive labels and decorations shall not be used.If the soother contains loose particles to produce a rattle effect, the particles shall be inert smooth beads. Suchbeads shall not be present in the teat.
EN 1400-1:2002 (E)115.2 Construction5.2.1 GeneralThe soother shall be free from any sharp projecting points or edges. The surface of the sucking part shall besmooth. The soother shall have no removable parts.NOTESoothers have been known to become lodged in a child's mouth. Attention should therefore be made to the designof all soother components to allow the assembled soother to be gripped as easily as possible, thereby facilitating removal of thesoother from the child's mouth.5.2.2 TeatThe effective penetration of the teat shall be a maximum of 35 mm. It shall be checked using for example the testpenetration gauge shown in Figure 52. The soother shall be inserted into the centre of the gauge with its major axisvertical and its teat in a downward position. The jaws of the gauge shall be adjusted until they just touch the neck ofthe teat. The soother shall be rotated to obtain the greatest depth of penetration, solely under the weight of thesoother. The tip of the teat shall not touch the top of the gauge block as shown in Figure 6.NOTEAdjust the opening of the jaws slightly if the teat does not have a circular cross section.The teat shall not include any hole in front of the shield.Any hollow section of the teat shall not contain solid, fluid or gaseous substances (except air) nor shall contain anyinserts except for the plug.
2 For this gauge please contac
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