SIST EN 1400-2:2003

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 2 : Mechanical requirements and testsSUHVNXVLArticles de puériculture - Sucettes pour nourrissons et jeunes enfants - Partie 2 : Exigences mécaniques et essaisArtikel für Säuglinge and Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Teil 2 : Mechanische Anforderungen und PrüfungenTa slovenski standard je istoveten z:EN 1400-2:2002SIST EN 1400-2:2003en97.190ICS:SLOVENSKI
STANDARDSIST EN 1400-2:200301-maj-2003







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1400-2September 2002ICS 97.190English versionChild use and care articles - Soothers for babies and youngchildren - Part 2 : Mechanical requirements and testsArticles de puériculture - Sucettes pour nourrissons - Partie2 : Exigences mécaniques et essaisArtikel für Säuglinge and Kleinkinder - Schnuller fürSäuglinge und Kleinkinder - Teil 2 : MechanischeAnforderungen und PrüfungenThis 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 1400-2:2002 E



EN 1400-2:2002 (E)2ContentspageForeword.3Introduction.41Scope.52Normative references.53Terms and definitions.54Description of a soother.75Performance of the soother.105.1Impact resistance.105.2Puncture resistance.105.3Tear resistance.115.4Knob, plug and/or cover retention.115.5Biting endurance.115.6Rotation endurance.115.7Integrity.116Testing.126.1Preparation of samples and general testing methods for oven treatment.136.2Test methods.13Annex A (informative)
Some examples of suitable fixing devices.22Annex B (informative)
Soothers - Assessment of compliance with standard - Sampling plan andcompliance levels for freshly manufactured samples.25B.1General.25B.2Sampling.25B.3Compliance level.25B.4Test methods and procedure.25B.5Threshold value.26



EN 1400-2:2002 (E)3ForewordThis document EN 1400-2:2002 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 1400 “Child use and care articles – Soothers for babies and young children” consists ofthe 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 two annexes:- annex A (informative) Some examples of suitable fixing devices- annex B (informative) Soothers - Assessment of compliance with standard - Sampling plan and compliance levelsfor freshly manufactured samplesAccording 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 1400-2:2002 (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 annex B (informative). This procedure can beused as a voluntary type approval procedure.Some concern was expressed regarding the softness of the soother teat. However as no approved testing methodwas found, it was decided to consider this aspect at the time of revision of this standard.



EN 1400-2:2002 (E)51 ScopeThis part of this European Standard specifies mechanical requirements and test methods for the performance ofsoothers for babies and young children.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 EN 1400-1:2002, 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 1400-1, Child use and care articles - Soothers for babies and young children - Part 1: General safetyrequirements and product information.EN 1400-3, Child use and care articles - Soothers for babies and young children - Part 3: Chemical requirementsand tests.EN ISO 1302, Geometrical Product Specifications (GPS) - Indication of surface texture in technical productdocumentation (ISO 1302:2002).ISO 188, Rubber, vulcanized or thermoplastic - Accelerated ageing or heat-resistance tests.EN ISO 3696, Water for analytical laboratory use - Specification and test methods (ISO 3696:1987).ISO 291, Plastics - Standard atmospheres for conditioning and testing.ISO 2859-1, Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptancequality limit (AQL) for lot-by-lot inspection.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 children
1 A standard for safety requirements and test methods for drinking equipment is in preparation.



EN 1400-2:2002 (E)6NOTESoothers 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 mouth3.4ring 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 pressure



EN 1400-2:2002 (E)74 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.Key1 Teat2 Shield3 Ring4 Plug5 Cover7 Sucking face of shieldFigure 1 - Example of a soother with ring



EN 1400-2:2002 (E)8Key1 Teat2 Shield4 Plug6 KnobFigure 2 - Example of a soother with knob



EN 1400-2:2002 (E)9Key1 Teat2 Shield4 Plug5 Cover7 Sucking face of shieldFigure 3 - Example of a soother with plug and cover



EN 1400-2:2002 (E)10Key1 Teat2 Shield4 Plug5 Cover6 KnobFigure 4 - Example of a soother with a combined plug, cover and knob5 Performance of the soother5.1 Impact resistanceThe soother shall be tested as described in 6.2.1 and no part shall break, tear or separate during this test or thetensile strength test described in 6.2.7.1.5.2 Puncture resistanceThe soother shall be tested as described in 6.2.2. When tested for puncture resistance as described in 6.2.2.1, theload to cut completely through one wall of the teat shall be greater than 30 N.If the soother is fitted with a flexible knob, when tested for puncture resistance as described in 6.2.2.2, the load tocut completely through one wall of the knob shall be greater than 30 N.



EN 1400-2:2002 (E)115.3 Tear resistanceThe soother shall be tested as described in 6.2.3. When tested for tear resistance as described in 6.2.3.1, the teatshall not break or separate during the tensile strength test.If the soother is fitted with a flexible knob, when tested for tear resistance as described in 6.2.3.2, the knob shall notbreak or separate during the tensile strength test.5.4 Knob, plug and/or cover retentionThe soother shall be tested as described in 6.2.4 and no part shall break or separate to become an accessible part.5.5 Biting enduranceThe teat and soft flexible knobs of the soother shall be tested as described in 6.2.5 and no part shall break, tear orseparate during this test or tensile strength test as described in 6.2.7.1. If the design of the soother makes itimpossible to apply a tensile force to the two sides of the biting surface on the flexible material, then the materialshall not exhibit either any evidence of being cut or any separation between flexible and rigid parts of the soother.Marks, confined to the surface of the flexible material, shall be ignored.5.6 Rotation enduranceSoothers incorporating any part capable of being rotated (360°) within the teat of the soother when a torque of(1 ± 0,2) Nm is applied, shall be tested as described in 6.2.6 and the teat shall not tear or separate during this testor tensile strength test as described in 6.2.7.1.5.7 IntegrityAdditional tests shall be carried out to ensure the integrity of all components not already examined as part of 6.2.1to 6.2.6.The soother shall be tested as described in 6.2.7.2 and no part shall break, tear or separate during the test.



EN 1400-2:2002 (E)126 TestingSamples taken direct from manufacturerprior to being placed on the marketAll other samples6.1.1 Pretreatment6.1.3 Conditioning6.1.2 Boiling6.1.3 Conditioning6.1.4 A sample used in any of the tests below shall not be used in any further testsAll soothers6.2.1 ImpactresistancetestFollowed by6.2.7.1Tensile testalong themajor axis(see FigureA.1)6.2.2.1Punctureresistancetest of teat6.2.3.1 Tearresistancetest of teatFollowed by6.2.7.1Tensile testAt rightangles tothe majoraxis(see FigureA.2)6.2.4 Knob,plug and/orcoverretentiontest6.2.
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