EN 12586:2007

Child use and care articles - Soother holder - Safety requirements and test methods

This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and labelling of soother holders (see B.1).
It includes test methods for the mechanical and chemical requirements specified.
All products that are intended to be used by a child to connect a soother with any other product are included in the scope of this European Standard.
This European Standard is intended to provide safety requirements for soother holders which are generally comprised of a strap with the holder at one end which retains the soother whilst the other end has a clasp that attaches to the child’s garment.
Where a soother holder has been classified as a toy or considered to have significant play value then the soother holder will have to meet the essential safety requirements for toys as stated in the Toy Directive (88/378/EEC) in addition to those in this European Standard. The addition of decorations or providing animal shaped fasteners should not automatically make the soother holder a toy; however the addition of a toy component to the soother holder will require that both the soother holder and the toy meet the essential safety requirements as stated in the Toy Directive. Where there is doubt concerning classification of a soother holder as a toy then advice should be sought from an EU Toy Notified Body or the Member State’s Competent Authority for toys (see B.2).

Artikel für Säuglinge und Kleinkinder - Schnullerhalter - Sicherheitstechnische Anforderungen und Prüfverfahren

In dieser Europäischen Norm werden Sicherheitsanforderungen an Werkstoffe, Bau, Ausführung, Verpackung
und Kennzeichnung von Schnullerhaltern festgelegt.
Sie enthält Prüfverfahren für die festgelegten mechanischen und chemischen Anforderungen.
Sämtliche Produkte, die dafür bestimmt sind, beim Kind den Schnuller mit einem anderen Produkt zu
verbinden, sind im Anwendungsbereich dieser Norm erfasst.
Es gibt einige Produkte, die für mehr als einen Zweck vorgesehen sind, z. B. könnte ein Schnullerhalter eine
Rassel oder ein Weichspielzeug aufnehmen. Andererseits könnte die Verbindungsschnur eine Kordel mit
dekorativ gefärbten Perlen haben. Jedes dieser Produkte sollte den Anforderungen der vorliegenden Norm
entsprechen. Sofern diese Produkte auch Spielzeug sind, sollte das Gesamtprodukt zusätzlich den
entsprechenden Anforderungen der EN 71 entsprechen.

Articles de puériculture - Attache sucette - Exigences de sécurité et méthodes d'essai

La présente Norme européenne spécifie les exigences de sécurité relatives aux matériaux, à la fabrication, aux performances, à l'emballage et à l'étiquetage des attache sucettes.
Elle comprend des méthodes d'essai portant sur les exigences mécaniques et chimiques spécifiées.
Tous les produits destinés à être utilisés pour fixer une sucette à un autre produit entrent dans le cadre de la présente norme.
Certains produits ont plusieurs fonctions, par exemple, une attache sucette peut intégrer un hochet ou un jouet souple. Le lien peut également être assorti d'un rang de perles décoratives de couleur. Il convient que tous ces produits soient conformes aux exigences de la présente norme. Cependant, comme ces produits sont également des jouets, il convient que l'ensemble du produit satisfasse, en outre, aux exigences correspondantes de l'EN 71.

Izdelki za otroke - Držalo dude - Varnostne zahteve in preskusne metode

General Information

• Status: Withdrawn
• Publication Date: 09-Oct-2007
• Withdrawal Date: 11-Jan-2011
• ICS: 97.190 - Equipment for children
• Technical Committee: CEN/TC 252 - Child use and care articles
• Drafting Committee: CEN/TC 252/WG 5 - Feeding, drinking, sucking and similar functions
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 12-Jan-2011
• Completion Date: 12-Jan-2011
• Directive: 2001/95/EC - Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety
• Mandate: M/264 - Mandate to CEN and CENELEC in the field of consumer safety related to the safety of child-care articles
• Ref Project: SIST EN 12586:2008 - Child use and care articles - Soother holder - Safety requirements and test methods

Relations

• Replaces: EN 12586:1999 - Child care articles - Soother holder - Safety requirements and test methods
• Effective Date: 22-Dec-2008
• Replaces: EN 12586:1999/AC:2002 - Child care articles - Soother holder - Safety requirements and test methods
• Effective Date: 22-Dec-2008
• Merged Into: EN 12586:2007+A1:2011 - Child use and care articles - Soother holder - Safety requirements and test methods
• Effective Date: 19-Jan-2023
• Amended By: EN 12586:2007/FprA1 - Child use and care articles - Soother holder - Safety requirements and test methods
• Effective Date: 13-Jun-2009

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Child use and care articles - Soother holder - Safety requirements and test methodsIzdelki za otroke - Držalo dude - Varnostne zahteve in preskusne metodeArticles de puériculture - Attache sucette - Exigences de sécurité et méthodes d'essaiArtikel für Säuglinge und Kleinkinder - Schnullerhalter - Sicherheitstechnische Anforderungen und PrüfverfahrenTa slovenski standard je istoveten z:EN 12586:2007SIST EN 12586:2008en,fr,de97.190Otroška opremaEquipment for childrenICS:SIST EN 12586:2002/AC:2003SIST EN 12586:20021DGRPHãþDSLOVENSKI
STANDARDSIST EN 12586:200801-januar-2008

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 12586October 2007ICS 97.190Supersedes EN 12586:1999
English VersionChild use and care articles - Soother holder - Safetyrequirements and test methodsArticles de puériculture - Attache sucette - Exigences desécurité et méthodes d'essaiArtikel für Säuglinge und Kleinkinder - Schnullerhalter -Sicherheitstechnische Anforderungen und PrüfverfahrenThis European Standard was approved by CEN on 20 July 2007.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 CEN 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 CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 12586:2007: E

Warnings.39 Annex B (informative)
Rationale.42 Annex C (informative)
Suitable method for the determination of phthalate plasticisers.47 Bibliography.51

(ISO 105-A03:1993) EN ISO 105-E01, Textiles — Test for colour fastness — Part E01: Colour fastness to water
(ISO 105-E01:1994) EN ISO 105-E04, Textiles — Test for colour fastness — Part E04: Colour fastness to perspiration
(ISO 105-E04:1994) EN ISO 291, Plastics — Standard atmospheres for conditioning and testing (ISO 291:2005) EN ISO 14184-1, Textiles — Determination of formaldehyde — Part 1: Free and hydrolyzed formaldehyde (water extraction method) (ISO 14184-1:1998)

3.4 soother fastener device for securing the soother holder to the soother 3.5 strap connecting device between a garment fastener and the soother fastener 3.6 touch-and-close device device having fibre interlocking faces, which are secured when pressed together 3.7 clothing fastener device part of the garment fastener that attaches it to the clothing 3.8 press stud device with two parts that engage when pressed together 3.9 ventilation hole (see B.11) hole of any shape that includes a circular area of at least 4 mm diameter 3.10 supplementary component part attached to the soother holder other than fasteners, press studs or touch-and-close devices 3.11 cord (see B.9) piece of slender, flexible material including monofilaments, woven and twisted cord, rope, plastic textile tapes, ribbons and fibrous materials commonly called string 4 Description of a soother holder A soother holder may consist of:  garment fastener;  strap;

Key 1 garment fastener 2 strap 3 soother fastener attached to ring of soother 4 touch-and-close device 5 press stud 6 ventilation hole 7 soother fastener attached to knob of soother Figure 1 — Examples of soother holders assembled with soothers

Key 1 garment fastener 2 strap 3 clothing fastener device 4 soother fastener 5 ventilation hole Figure 2 — Examples of soother holders

Key 1 detachable supplementary component
2 supplementary components in the form of beads 3 soother fastener in the form of a loop of cord 4 permanently attached supplementary component
Figure 3 — Examples of soother holders with supplementary components

5.1.12.6 Supplementary components as toys If any supplementary component resembles a toy then the complete soother holder shall additionally meet the requirements of the Toy Directive. 5.2 Mechanical requirements 5.2.1 Impact resistance (see 6.1.5) The soother holder shall be tested in accordance with 6.1.5 and no part shall break, tear or separate during this test. The tested soother holder shall be used in test 6.1.6. 5.2.2 Durability of the garment fastener (see 6.1.6) The garment fastener shall be tested in accordance with 6.1.6 and no part shall break, tear or separate during this test or the consecutive tensile strength test. 5.2.3 Tensile strength (see 6.1.7) After the impact resistance test and the garment fastener durability test, the integrity of the soother holder shall be tested in accordance with 6.1.7. No part shall break, tear or separate. 5.3 Chemical requirements (see B.3) 5.3.1 General Materials used for the manufacture of soother holders shall be subjected to the tests listed in Table 1 and shall conform to 5.3.3 to 5.3.11. Each test shall be carried out on a new sample. If any part of the soother holder including a supplementary component resembles a toy then the complete soother holder shall additionally meet the requirements of the Toy Directive. 5.3.2 Requirements by material Materials used in the manufacture of components of soother holders shall be subjected to the tests marked with an x in Table 1.

Migration of certain elements Nickel Colour fastness Formal-dehyde Phthalate content Colourants Primary aromatic amines Monomers Wood preserva-tives Requirement clause 5.3.3 5.3.4 5.3.5 5.3.6 5.3.7 5.3.8 5.3.9 5.3.10 5.3.11 Test clause 6.2.1 6.2.2 6.2.3
6.2.4 6.2.5 6.2.6 6.2.7 Textiles - Fabrics, strings, ribbons etc. x
x x
x x
Decorations x
x x
Metal parts x x
Wooden parts x
x x
x x
x Plastics
x
x
x
5.3.3 Migration of certain elements (see 6.2.1) The migration of certain elements from all materials used in the manufacturing of soother holders shall not exceed the limits given in Table 2 when tested in accordance with 6.2.1. When soother holders contain parts manufactured from different materials or in different colours, all parts shall be tested individually. Table 2 — Limits of element migration from soother holder materials Element Limit (mg/kg)Antimony (Sb) Arsenic (As)
Barium (Ba)
Cadmium (Cd) Chromium (Cr)Lead (Pb)
Mercury (Hg)
Selenium (Se) 60 25 1 000 75 60 90 60 500
5.3.4 Nickel (see 6.2.2) Nickel shall not be used in metal parts which may come into direct prolonged contact with the skin if the rate of nickel release from the part of the product in direct contact with the skin is greater than 0,5 µg/cm2/week, when tested in accordance with 6.2.2 [1].

5.3.8 Colourants (see 6.2.4 and B.5) 5.3.8.1 Decorations shall be tested in accordance with 6.2.4 and the concentration of a colourant shall not exceed the limits given in Table 4. 5.3.8.2 Textile components and wooden parts of the soother holder failing the requirement of 5.3.5 shall be tested in accordance with 6.2.4 and the concentration of a colourant shall not exceed the limits given in Table 4.

5.3.9 Primary aromatic amines (see 6.2.5 and B.5) 5.3.9.1 Decorations shall be tested in accordance with 6.2.5 and the concentration of a primary aromatic amine shall not exceed the limits given in Table 5. 5.3.9.2 Textile components and wooden parts of the soother holder failing the requirement of 5.3.5 shall be tested in accordance with 6.2.5 and the concentration of a primary aromatic amine shall not exceed the limits given in Table 5. Table 5 — Primary aromatic amines (see B.5 and B.6) Compound CAS number Limit Benzidine 92-87-5 Action limit 2-Naphthylamine 91-59-8 Action limit 4-Chloroaniline 106-47-8 Action limit 3.3'-Dichlorobenzidine 91-94-1 Action limit 3,3'-Dimethoxybenzidine 119-90-4 Action limit 3.3'-Dimethylbenzidine 119-93-7 Action limit o-Toluidine 95-53-4 Action limit 2-Methoxyaniline (o-Anisidine) 90-04-0 Action limit Aniline 62-53-3 Action limit

a
Limits are expressed as amount of substance per litre of simulant (see EN 71-11).
5.3.11 Wood preservatives (see 6.2.7) When tested in accordance with 6.2.7 the migration of preservatives from wooden components of the soother holder shall not exceed the limits given in Table 7. Table 7 — Wood Preservatives (see B.6) Compound CAS number Limit
Cyfluthrin 68359-37-5 Action limit Cypermethrin 52315-07-8 Action limit Deltamethrin 52918-63-5 Action limit Permethrin 52645-53-1 Action limit Pentachlorophenol and its salts various Action limit Lindane 58-89-9 Action Limit
6 Test methods 6.1 Mechanical tests 6.1.1 Preparation of samples and general testing conditions All samples shall be conditioned before the tests. Conditioning of the samples shall be performed for at least 40 h in a standard atmosphere in accordance with EN ISO 291, temperature (23 ± 2) °C and relative humidity (50 ± 5) %. Samples shall remain in the conditioning atmosphere until the test is carried out. The tests can be carried out in a non-conditioned room.

6.1.1 Preparation of samples
5.1.3 Visual and tactile
5.1.4.1 Finger traps
5.1.5 Decoration
5.1.6 Length
5.1.7 Strap width
5.1.8.1 Cord thickness
5.1.8.2 Exposed cord length
5.1.9 Maximum size of press studs, touch-and -close and similar devices
5.2.1 Impact resistance
5.2.2 Durability of the garment fastener
5.2.3 Tensile strength 5.1.10 Permanent fasteners
5.1.11 Detachable fasteners
5.1.12 Supplementary components
5.1.4.2 Ventilation holes
Figure 4 — Order of testing for general and mechanical requirements 6.1.3 Measurement of length (see 5.1.6 and 5.1.12.2) The principle is to determine the longest length of the soother holder, which might be a combination of the strap, soother fastener and a supplementary component where present. Therefore the tensile force of (25 ± 2) N shall be applied in such a way that the longest length is achieved. All configurations shall be measured in order to ascertain the longest length excluding the garment fastener.

8).
Key 1 garment fastener 2 clothing fastener device 3 open press stud 4 open touch-and-close device 5 maximum length 220 mm Figure 5 — Measurement of soother holder length when press studs or touch-and-close devices are present

Key 1 garment fastener 2 clothing fastener device 3 permanently attached soother fastener 4 maximum length 220 mm Figure 6 — Measurement of soother holder length when a permanently attached soother fastener is present

Key 1 garment fastener 2 clothing fastener device 3 permanently attached soother fastener 4 maximum length 220 mm 5 supplementary component Figure 7 — Measurement of soother holder length when a supplementary component is present

Key 1 length before applying 25 N tensile force 2 length after applying 25 N tensile force Figure 8 — An example of the effect on soother holder length when a supplementary component
and a soother fastener in the form of a loop are present 6.1.4 Measurement of width 6.1.4.1 Strap connecting the soother fastener with the garment fastener (see 5.1.7) The measurement shall be made with a force of (25 ± 2) N applied along the length of the strap, the strap being vertical (see Figure 9). For a chain or a beaded strap, the measurement shall apply to the overall width of a link or a bead (see Figure 9). In all cases several measurements shall be made in order to ascertain the minimum width.

Key 1 cloth strap 2 chain strap 3 bead strap 4 minimum width 6 mm Figure 9 — Measurement of strap width

Key 1 minimum width 6 mm Figure 10 — Measurement of width of strap connecting a supplementary component 6.1.4.3 Cord thickness (see 5.1.8.1) During either tests 6.1.4.1 and 6.1.4.2 measure the thickness of the cord whilst under a tension of (25 ± 2) N between three and five points along its length and determine the average thickness to a tolerance of 0,1 mm. For cords approaching 1,5 mm in thickness use a non-compressible method, e.g. an optical projector. Examples of measurement positions are shown in Figure 11.

Key 1 cord thickness measurement position Figure 11 — Examples of measurement positions for cord thickness 6.1.4.4 Exposed cord length (see 5.1.8.2) During either tests 6.1.4.1 and 6.1.4.2 measure the length of cord exposed whilst under a tension of (25 ± 2) N. If the cord is exposed in more than one position measure each exposure and calculate the total length of exposure. Examples of measurement positions are shown in Figure 12.

Key 1 exposed cord length measurement Figure 12 — Examples of measurement of exposed cord length 6.1.5 Impact resistance test (see 5.2.1) Each part of the soother holder shall be tested as follows: Place the part of the soother holder to be tested unsupported on a flat, horizontal steel surface. Drop a metallic weight with a mass of (1 ± 0,02) kg, distributed over an area of diameter (80 ± 2) mm, from a height of (100 ± 2) mm above the highest point of the part to be tested so that the centre of the weight is the first point to contact each tested part of the soother holder. The test shall be carried out 5 times on each part of the same sample. The holder shall be placed in different stable orientations before each impact. If either fastener has both stable opened and closed positions, as far as practicable both positions shall be used.

1 000 cycles from opening to closing. A (3 ± 0,3) mm test plate with a Shore A hardness of 40 ± 5 shall be placed between the jaws. The duration of each cycle shall be (5 ± 2) s. The test may be carried out either manually or using a suitable test fixture. Some examples of the opening and closing mechanisms are shown in Figure 13. After this test the garment fastener shall be tested for tensile strength in accordance with 6.1.7.

Key 1 3 mm plate Figure 13 — Some examples of opening and closing mechanisms (see 6.1.6.2) 6.1.7 Tensile strength tests (see 5.2.3) 6.1.7.1 General instructions for all tensile strength tests Parts to be tested shall be held securely by clamps or by such other means as might be required depending on the design of the soother holder. The tensile force shall be applied to one component of the holder whilst another part is firmly held. A preload of (5 ± 2) N shall be applied to align the specimen and then the force shall be increased to (90 ± 5) N at a crosshead speed of (200 ± 5) mm/min and maintained at that load for (10 ± 0,5) s. Clamps or other devices shall hold the component securely during the test without giving rise to damage which might affect the test result. Any result where such damage occurs shall be disregarded. The following pairs of components shall be tested (depending on the design of the soother holder):

- strap (7) supplementary component
- garment fastener (8) supplementary component
- soother fastener
Additional tests shall be carried out to ensure the integrity of all components. All single components shall be tested and also every possible combination of pairs of components, if this has not been carried out in other tests. As the purpose of these series of tests is to reduce the risk of the soother holder coming apart, the force shall be applied in the most onerous position. 6.1.7.2 Test along the length of the soother holder Tensile tests shall be carried out on all the above pairs of components (if fitted) by exerting the force along the length of the soother holder. Where the soother fastener is manufactured as a separate item but is permanently fixed to the strap/chain it is permissible for the fastener to open below (90 ± 5) N and this shall not be counted as a failure. If the fastener does open the test shall be continued until the limit is reached. 6.1.7.3 Test at right angles to the main axis of the soother holder Tensile tests shall be carried out as described in 6.1.7.2 but by holding the garment fastener or soother fastener at right angles to the direction in 6.1.7.2. Depending on the design of the parts of the soother holder there may be more than one way in which a force can be exerted at right angles to that in 6.1.7.2. Tests shall be carried out in all these directions. Where the soother fastener is manufactured as a separate item but is permanently fixed to the strap/chain it is permissible for the fastener to open below (90 ± 5) N and this shall not be counted as a failure. If the fastener does open the test shall be continued until the limit is reached. 6.1.8 Finger traps test (see 5.1.4.1) Using a 5,5 mm probe (see Figure 14) measure the penetration of any accessible hole. If the unhindered penetration is more than 10 mm, repeat using a 12 mm diameter probe.

Key 1 radius 2 scribed line
3 diameter of probe: 5,501,0− mm or 121,00+ mm Figure 14 — Probes for holes (finger traps) test method 6.1.9 Guide tests (see B.10) 6.1.9.1 Principle Three different guides (see Figure 15, Figure 16 and Figure 17) are used for this test although the basic method is the same for all guides. 6.1.9.2 Method Position and clamp the appropriate guide so that the slot is horizontal and unobstructed at its top and bottom openings. Orientate the part to be tested (fastener or supplementary component) in a position that would most likely permit the entry of the part through the slot in the guide. Place the part in the slot so that the only force on the fastener or supplementary component is the force due to its mass. Observe whether any part of the fastener or supplementary component protrudes past the base of the guide. If the fastener is permanently attached to the strap, the penetration of the strap past the base of the guide shall be ignored. If any supplementary component has a length of strap, then the penetration of the strap past the base of the guide shall be ignored.

Figure 15 — Guide 1
Figure 16 — Guide 2
Figure 17 — Guide 3 6.2 Chemical tests 6.2.1 Determination of migration of certain elements (see 5.3.3) The method stated in EN 71-3 shall be used for the determination of migration of certain elements in soother holders. NOTE Since EN 71-3 was originally written to cover all possible materials for toys and related products, it is recommended that the following titles and clauses are used when testing soother holders:

EN 71-3:1994 Clauses
5 Principle
6 Reagents and apparatus
6.1 Reagents
6.2 Apparatus
7 Selection of test portions
8 Preparation and analysis of test portions
8.1 Coatings of paints, varnish, lacquer, printing ink, polymer and similar coatings
8.2 Polymeric and similar materials including laminates, whether reinforced textile or not, but excluding other textiles
9 Determination of the quantity of migrated elements
10 Test report 6.2.2 Determination of the release of nickel (see 5.3.4) Metal parts regardless of coating shall be tested in accordance with EN 1811. 6.2.3 Determination of colour fastness (see 5.3.5) Colour fastness to water shall be tested in accordance with EN ISO 105-E01 and colour fastness to perspiration shall be tested in accordance with EN ISO 105-E04. The fastness grade determined on the adjacent fabric shall be determined by using the grey scale for assessing staining according to EN 20105-A03. 6.2.4 Test method for colourants (see 5.3.8) 6.2.4.1 Textile sample preparation, extraction and analysis Different colours of the same textile material shall be treated separately provided a single test portion with a minimum area of 1 cm2 can be taken. If single test portions of a minimum of 1 cm2 cannot be taken, then the test portions described below shall be representative of all the colours present. Remove test portions from the sample with a suitable blade. Cut each test portion such that no dimension exceeds 3 mm. Store each test portion separately in a suitable container. Weigh, to the nearest 1 mg, approximately 0,5 g of the test portion into a 40 ml amber glass vial with a
PTFE-liner screw cap. Add 10 ml ethanol and place the vial in an ultrasonic bath for 15 min. Transfer the extract into a test tube and concentrate to about 1 ml under a stream of air or nitrogen. Filter the extract, transfer to a 2 ml vial and crimp. Analyse the extract in accordance with 5.3 of EN 71-11:2005. 6.2.4.2 Wooden sample preparation, extraction and analysis Prepare and extract the sample in accordance with 8.3 of EN 71-10:2005. Analyse the extract in accordance with 5.3 of EN 71-11:2005.
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