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

Status
Published
Publication Date
04-Sep-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
05-Sep-2018
Completion Date
05-Sep-2018

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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
SIST EN 1400:2013+A2:2018
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

EN 1400:2013+A2:2018 (E) 2 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 SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 3 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. SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 4 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.$ SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 5 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-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+A2:2018

EN 1400:2013+A2:2018 (E) 6 3.3 shield structure positioned at the rear of the teat to reduce the likelihood of the soother being drawn entirely into the child's mouth 3.4 ring 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 SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 7 3.11 major axis of the soother major axis of the soother goes at right angles to the shield and through the centre of the teat, where the teat enters the shield Note 1 to entry: See Figure 14. 3.12 major axis of the shield major axis of the shield is parallel to the longest dimension of the shield and in the middle of the width Note 1 to entry: See Figure 15. 4 Description of a soother A soother, as shown in Figures 1, 2, 3 and 4, normally consists of: — a teat, — a shield, and — either a ring or knob, and can include: — a plug, and — a cover. NOTE 1 Similar components are marked with the same number in Figures 1 to 4. NOTE 2 Some or all of the components may be manufactured from the same material which may result in the components not being separately distinguishable. NOTE 3 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. SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 8

Key 1 teat 2 shield 3 ring 5 cover 7 sucking face of shield 8 rear face of shield Figure 1 — Example of a soother with ring SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 9

Key 1 teat 2 shield 4 plug 6 knob Figure 2 — Example of a soother with knob SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 10

Key 1 teat 2 shield 4 plug 5 cover 6 knob 7 sucking face of shield 8 rear face of shield Figure 3 — Example of a soother with plug and cover

SIST EN 1400:2013+A2:2018
EN 1400:2013+A2:2018 (E) 11

Key 1 teat 2 shield 4 plug 6 knob Figure 4 — Example of a soother with a combined plug and knob 5 Test equipment 5.1 Shield template The shield template shall be made from Polyoxymethylene (POM), standard (natural, non pigmented, unfilled), E-modulus: 3000 MPa to 3300 MPa, hardness: 80 to 90 Shore D, Surface roughness: lower than Ra 2,2. NOTE Extruded sheets of POM normally meet the surface roughness requirement. The dimensions shall be as shown in Figure 5. SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 12 Dimensions in millimetres

Key 1 enlarged part section A – A 2 permanent marks for major and minor axes Figure 5 — Shield template 5.2 Test spheres Test spheres A, B, C and D, shall be made from stainless steel of diameters given in Table 1. SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 13 Table 1 — Test sphere diameters Test sphere Diameter mm A 10004,,+− B 01,05,5+− C 0,1012+− D 1,0014+− 5.3 Indentor The indentor is made from H13 high chrome tool steel or equivalent and hardened to a minimum of 50 Rockwell C and shall have dimensions as shown in Figure 6. All dimensions with a tolerance are machined as in EN ISO 1302 to Ra0,4.The larger diameter of the indentor has not been specified, as it should be of a size to fit into the equipment for applying the necessary force specified in the test methods. Dimensions in millimetres

Key a This face is flat and has dimensions of (3,0 x 0,20) mm. Figure 6 — Indentor 5.4 Cutting board The cutting board is made from a polymeric material of (70 ± 5) Shore D hardness with a stop made from any suitable material to the dimensions as shown in Figure 7. All dimensions shall have a tolerance SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 14 of ± 2 mm except where indicated. A centre line and point of puncture is to be marked onto the surface as shown in Figure 7. Dimensions in millimetres

Key 1 stop for cut edge of teat 2 position of teat 3 point of puncture Figure 7 — Cutting board 5.5 Bite endurance jaws The jaws are made from H13 high chrome tool steel or equivalent and hardened to (45 to 50) Rockwell C and shall have dimensions as shown in Figure 8. All dimensions with a tolerance are machined as in EN ISO 1302 to Ra0,4. All dimensions for the top and bottom jaws are identical. SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 15 Dimensions in millimetres

Figure 8 — Bite endurance jaws 5.6 Impact mass A flat stainless steel weight with radiused edges (2 ± 0,5) mm and a mass of (1 ± 0,02) kg, distributed over an area of diameter (80 ± 2) mm, see Figure 9. Dimensions in millimetres

Key a radius (2 ± 0,5) mm Figure 9 — Impact mass SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 16 5.7 Guides Guides 1, 2 and 3 with dimensions as shown in Figures 10, 11 and 12. Dimensions in millimetres

Figure 10 — Guide 1 SIST EN 1400:2013+A2:2018
EN 1400:2013+A2:2018 (E) 17 Dimensions in millimetres
Figure 11 — Guide 2 SIST EN 1400:2013+A2:2018
EN 1400:2013+A2:2018 (E) 18 Dimensions in millimetres

Figure 12 — Guide 3 6 General 6.1 Tolerances for construction and mechanical properties Unless otherwise stated, the following tolerances apply: — forces: ± 5 % of the nominal force; — masses: ± 0,5 % of the nominal mass; — dimensions: ±1,0 mm of the nominal dimension; — angles: ± 2º of the nominal angle; SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 19 — duration of forces for durability tests:

± 1 s; — duration of forces for static load tests: ± 2 s. The tests are described in terms of the application of forces. Masses can however be used. 1 kg mass may be used for 10 N force. Unless otherwise specified, the test forces may be applied by any suitable device which does not adversely affect the results. 6.2 Order of tests for construction and mechanical properties The tests shall be carried out in the order given in Table 2. Table 2 — Order of testing for construction and mechanical properties Order of Testing Test Clause Samples taken direct from manufacturer prior to being placed on the market All Other samples

6.3.1 Pre-treatment No pre-treatment
6.3.2 Boiling
6.3.3 Conditioning

6.3.4 A sample used in any of the tests below shall not be used in any further tests 1 8.1 - 8.9 Construction properties and tests 2 9.1.2 9.7.2.2 Impact resistance followed by Tensile test along the major axis (see Annex D, Figure D.1) 3 9.2.2.1 Puncture resistance of teat 4 9.3.2.1 9.7.2.2 Tear resistance of teat followed by Tensile test at right angles to the major axis (see Annex D, Figure D.2) 5 9.4.2 Knob, plug and/or cover retention 6 9.5.2 9.7.2.2 Bite endurance of elastomeric components followed by Tensile test at right angles to the major axis (see Annex D, Figure D.2) 7 9.7.2.3 Tensile tests for single components and pairs of components 8 9.7.2 Integrity

Additional requirements for soothers with knobs made of flexible materials 9 9.2.2.2 Puncture resistance of knob made of flexible materials SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 20 Order of Testing Test Clause Samples taken direct from manufacturer prior to being placed on the market All Other samples 10 9.3.2.2 9.7.2.2 Tear resistance of knob made of flexible materials followed by Tensile test at right angles to the major axis (see Annex D, Figure D.2) 11 9.5.2 9.7.2.2 Bite endurance of elastomeric components followed by Tensile test at right angles to the major axis (see Annex D, Figure D.2)

Additional tests for soothers where a part rotates inside the teat (See 9.6) 12 9.6.2 9.7.2.2 Rotation endurance followed by Tensile test along the major axis (see Annex D, Figure D.1)

6.3 Preparation of samples for construction and mechanical tests 6.3.1 Pre-treatment Only samples taken directly from the manufacturer (see B.4.1) prior to being placed on the market shall be artificially aged for (7 days) ± 2 h in a cabinet oven with forced air circulation by means of a fan and a ventilation of three to ten changes per hour (as described as Method B in ISO 188) at a temperature of (70 ± 2) °C and conditioned as described in 6.3.3. 6.3.2 Boiling All samples shall be immersed in boiling water, to the requirements of EN ISO 3696, Grade 3, for (10 ± 1) min without touching the walls of the container and removed (see B.4.2). Afterwards, allow the samples to cool to room temperature. 6.3.3 Conditioning All samples shall be conditioned before the tests. The conditioning of the samples shall be performed for at least 40 h in a temperature (23 ± 2) °C, and relative humidity (50 ± 5) %. Samples shall remain in the conditioning atmosphere until the test is carried out. The tests may be carried out in a non-conditioned room. 6.3.4 New samples New samples, preferably from the same batch, shall be used for each test (i.e. samples used in one test shall not be used in another test) or for each testing orientation, unless otherwise stated. SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 21 6.4 Preparation of samples for chemical tests 6.4.1 General The sample preparation (6.4.2) applies to all tests except N-Nitrosamines and N-Nitrosatable substances release; see 10.4. Samples and test portions shall only be handled with suitable (for example, non-rubber) gloves and shall only be stored in securely fastened, migration free containers and protected from the light. 6.4.2 Boiling All samples shall be immersed in boiling water, to the requirements of EN ISO 3696, Grade 3, for (10 ± 1) min without touching the walls of the container and removed. Store in a closed container; a desiccator for example is ideal for this purpose. This is to reduce the risk of contamination. 6.4.3 New samples New samples, preferably from the same batch, shall be used for each test, i.e. samples used in one test shall not be used in another test unless otherwise stated. 7 Printing and decals There shall be no printing on the sucking face of the shield. Adhesive decals and labels shall not be attached to any part of the soother. No decorations shall be attached to any part of the soother by glue. A soother may be decorated, including moulded in, imprinting and printing. Imprinting may include techniques such as stamping and laser etching. No form of decoration shall be removed during the boiling stage (see 6.3.2). 8 Construction properties and tests 8.1 General The soother shall be free from any sharp points or edges and free of flash and burrs. The soother shall have no removable parts other than a teat protector (see Clause 11). Soothers have been known to become lodged in a child's mouth. Attention should therefore be made to the design of all soother components to allow the assembled soother to be gripped as easily as possible, thereby facilitating removal of the soother from the child's mouth. Attention should also be made to the design of the soother to ensure that it may be cleaned as easily and as efficiently as possible (see B.3). 8.2 Teat (see B.5) 8.2.1 Requirements When tested in accordance with 8.2.2, the effective penetration of the teat shall not be greater than 35 mm. The teat shall not include any hole in front of the sucking face side of the shield. Any hollow section of the teat shall not contain solid, fluid or gaseous substances (except air) nor shall it contain any inserts except for the plug. SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 22 8.2.2 Test method for effective penetration The effective penetration is the distance from the tip of the teat to where the teat enters the shield along the major axis, see Figure 13, and shall be measured using a suitable measuring device with an accuracy of 0,1 mm. Dimensions in millimetres

Figure 13 — Measurement of teat penetration 8.3 Shield (see B.6) 8.3.1 Requirements The soother shall incorporate a shield. When tested in accordance with 8.3.2, the shield shall not pass through the shield template. 8.3.2 Test method The shield template, see 5.1, shall be supported horizontally so that it remains firm and horizontal throughout the test and there is no lateral movement of the shield template. NOTE It will assist the test if the shield is marked with its major and minor axes on both the sucking face and the rear face. These marked axes can then be lined up with the permanent marks on the shield template (see Figure 5). Immerse the soother for at least 10 s in an aqueous solution of a wetting agent. A 2 % (V/V) solution of polyoxyethylene (20) sorbitan mono-oleate is suitable. Position the wet soother with the sucking face of the shield against the opening in the template; such that the major axis of the soother goes through the intersection of the axes marked on the template (see Figure 14). Orientate the soother, until the major axis of the shield (see Figure 15) is parallel to the major axis of the template. At a crosshead speed of (100 ± 5) mm per min, apply a tensile force of (10 ± 0,5) N to the teat along the direction of the major axis of the soother, ensuring that there is no lateral movement causing a pendulum effect. That is, the major axis of the soother shall always be aligned with the centre of the template throughout the test. Maintain the load for (10 ± 0,5) s (see Figure 16 a)). Reverse the soother and repeat the test by pulling on the ring or the knob, using a suitable device (see Figure 16 b)). SIST EN 1400:2013+A2:2018

EN 1400:2013+A2:2018 (E) 23 If the design or position of the soother ring or knob makes this impossible, or if the shield slides sideways through the template during the test then cut off the teat and repeat the test with the soother reversed over the template. The force is applied from above through a rod centred in the hole left by the teat and along the major axis (see Figure 16 c)). The rod shall be a little larger in diameter than the size of the hole left by the teat. With some soothers (e.g. full rubber or full silicone soothers) using this rod may not be possible. In these instances a tube with an internal diameter of (15 ± 0/1) mm and a wall thickness of (1 ± 0,1) mm shall be used (see Figure 16d)). The teat shall be cut off as far as necessary to accommodate the tube.

Key a major axis of soother b intersection of major and minor axes of shield template c shield template (side view) d shield template (top view) Figure 14 — Major axis of soother in relation to the intersection of the axes marked on the shield template

SIST EN 1400:2013+A2:2018
EN 1400:2013+A2:2018 (E) 24

Key w half of shield width a-a major axis of shield Figure 15 — Example of the major axis of a shield

SIST EN 1400:2013+A2:2018
EN 1400:2013+A2:2018 (E) 25
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