SIST EN 12586:2008+A1:2011
(Main)Child use and care articles - Soother holder - Safety requirements and test methods
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 connect a soother for babies and young children 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.
Artikel für Säuglinge und Kleinkinder- Schnullerhalter - Sicherheitstechnische Anforderungen und Prüfverfahren
Diese Europäischen Norm legt sicherheitstechnische Anforderungen an Werkstoffe, Bau, Ausführung, Verpackung und Kennzeichnung von Schnullerhaltern fest (siehe B.1).
Sie enthält Prüfverfahren für die festgelegten mechanischen und chemischen Anforderungen.
Sämtliche Produkte, die dafür bestimmt sind, einen Schnuller für ein Baby oder Kleinkind mit einem anderen Produkt zu verbinden, sind im Anwendungsbereich dieser Europäischen Norm erfasst.
Das Ziel dieser Europäischen Norm ist die Festlegung von Sicherheitsanforderungen an Schnullerhalter, die üblicherweise aus einem Band bestehen, der an einem Ende die Befestigung für den Schnuller und am anderen Ende eine Klammer hat, die am Kleidungsstück des Kindes befestigt wird.
Wenn ein Schnullerhalter als Spielzeug klassifiziert wurde oder ihm ein wesentlicher Spielwert zuzuordnen ist, dann muss dieser Schnullerhalter zusätzlich zu den Anforderungen dieser Europäischen Norm alle wesentlichen Sicherheitsanforderungen an Spielzeug erfüllen, die in der Spielzeug Richtlinie (88/378/EWG) angegeben sind. Wenn Verzierungen vorhanden oder Befestigungselemente in Tierform gestaltet sind, sollte der Schnullerhalter nicht automatisch als ein Spielzeug angesehen werden; das Hinzufügen eines Spielzeugelements bewirkt jedoch, dass sowohl der Schnullerhalter als auch das Spielzeug die in der Spielzeug Richtlinie angegebenen wesentlichen sicherheitstechnischen Anforderungen erfüllen müssen. Wenn keine eindeutige Klassifizierung des Schnullerhalters als Spielzeug möglich ist, sollte die innerhalb der EU notifizierte Stelle für Spielzeug (Toy Notified Body) oder die für Spielzeug zuständige Behörde des Mitgliedstaates konsultiert werden (siehe B.2).
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 attaches sucettes (voir en B.1).
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 pour nourrissons et jeunes enfants à un autre produit entrent dans le cadre de la présente Norme européenne.
La présente Norme européenne a pour but de spécifier les exigences de sécurité relatives aux attaches sucettes généralement constituées d’un lien muni d’une attache à une extrémité qui retient la sucette, l’autre extrémité étant munie d’un clip qui permet de la fixer au vêtement de l’enfant.
Si une attache sucette a été classée dans la catégorie des jouets ou est considérée comme ayant une valeur ludique significative, l’attache sucette devra satisfaire aux exigences de sécurité essentielles relatives aux jouets visées dans la Directive «Jouets» (88/378/CEE) en plus des exigences spécifiées dans la présente Norme européenne. Il convient de ne pas considérer que l’ajout de décorations ou la présence de fixations en forme d’animaux classent automatiquement l’attache sucette dans la catégorie jouets ; toutefois, l’ajout d’un élément ludique à l’attache sucette nécessite que l’attache sucette et le jouet satisfassent aux exigences de sécurité essentielles visées dans la Directive «Jouets». En cas de doute relatif à la classification d’une attache sucette dans la catégorie jouets, il convient de demander l’avis d’un organisme de jouets notifié par l’UE ou de l’Autorité compétente de l’État membre en matière de jouets (voir en B.2).
Izdelki za otroke - Držalo dude - Varnostne zahteve in preskusne metode (vključno z dopolnilom A1)
Ta evropski standard določa varnostne zahteve, ki se nanašajo na materiale, sestavo, delovanje, pakiranje in označevanje držal dude. Vključuje preskusne metode za določene mehanske in kemične zahteve. Vsi proizvodi za povezavo držala dude za dojenčke in majhne otroke, s katerim koli drugim proizvodom so v območju uporabe tega evropskega standarda. Ta evropski standard zagotavlja varnostne zahteve za držala dud, ki so na splošno sestavljene iz paščka z držalom na eni strani, ki trdno drži dudo, medtem ko je na drugi strani zaponka, ki se pritrdi na otrokova oblačila. Kjer je bilo držalo dude klasificirano kot igrača ali kjer se je štelo, da ima pomembno težo pri igranju, mora držalo dude izpolnjevati bistvene varnostne zahteve za igrače, kot je navedeno v Direktivi o igračah (88/378/EGS), poleg navedenih v tem evropskem standardu. Dodatki v obliki dekoracij ali zaponke v obliki živali ne pomenijo samodejno, da je držalo dude igrača; vendar držalu dude dodana komponenta v obliki igrače zahteva, da držalo dude in igrača izpolnjujeta bistvene zahteve, kot so navedene v Direktivi o igračah. V primeru dvoma glede klasifikacije držala dude kot igrače se je treba obrniti na organ EU, ki se obvešča o igračah, ali ustrezni organ države članice, pristojen za igrače.
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- Schnullerhalter - Sicherheitstechnische Anforderungen und PrüfverfahrenArticles de puériculture - Attache sucette - Exigences de sécurité et méthodes d'essaiChild use and care articles - Soother holder - Safety requirements and test methods97.190Otroška opremaEquipment for childrenICS:Ta slovenski standard je istoveten z:EN 12586:2007+A1:2011SIST EN 12586:2008+A1:2011en,fr,de01-marec-2011SIST EN 12586:2008+A1:2011SLOVENSKI
STANDARDSIST EN 12586:20081DGRPHãþD
SIST EN 12586:2008+A1:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12586:2007+A1
January 2011 ICS 97.190 Supersedes EN 12586:2007English Version
Child use and care articles - Soother holder - Safety requirements and test methods
Articles de puériculture - Attache sucette - Exigences de sécurité et méthodes d'essai
Artikel für Säuglinge und Kleinkinder- Schnullerhalter - Sicherheitstechnische Anforderungen und Prüfverfahren This European Standard was approved by CEN on 20 July 2007 and includes Amendment 1 approved by CEN on 23 November 2010.
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, 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12586:2010+A1:2011: ESIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Terms and definitions .64Description of a soother holder .65Requirements . 106Test methods . 177Consumer packaging . 388Product information. 39Annex A (normative)
Warnings . 41Annex B (informative)
Rationale . 44Annex C (informative)
Suitable method for the determination of phthalate plasticisers . 49Bibliography . 53 SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 3 Foreword This document (EN 12586:2007+A1:2011) has been prepared by Technical Committee CEN/TC 252 “Child use and 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 July 2011, and conflicting national standards shall be withdrawn at the latest by July 2011. This document supersedes !EN 12586:2007". This document includes Amendment 1, approved by CEN on 2010-11-23. The start and finish of text introduced or altered by amendment is indicated in the text by tags ! ". Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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.
SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 4 Introduction Accidents caused by soothers are few and any resulting in the death of a child are almost unknown. However, a small number of children die as a result of accidents where a soother is involved, but in these cases death almost always results from strangulation by a cord being used to hang the soother around the child's neck. Such cords are usually either home-made or made for some other purpose, e.g. a coiled key ring holder. This European Standard is the first for this type of product and its main aim is to eliminate the risk of strangulation. This has only been made possible by severely restricting the length of the soother holder. The length should be sufficient for its purpose while not being so long that the strap can encircle the neck and strangle even the smallest child. The lack of reported incidents involving accidents or fatalities since its introduction would suggest that this standard has achieved this main aim. A functional soother holder is not to be considered as a toy. However, a soother holder may contain a part or be designed in such a way as to present a double use. That is the soother holder, in addition to its functional use, also has a significant playing value and therefore could also be considered as a toy [2]. In these instances the entire product becomes a toy as well as being a soother holder and needs to meet the requirements of both the Toy Directive [3] as well as this European Standard. Chemical requirements for silicone rubber, vulcanized rubber and for thermoplastic elastomers have each been considered by the Technical Committee. They have not been included in this standard at this stage and will be reconsidered when further information becomes available. It is considered that for organic chemical compounds, the requirements, sample preparation and extraction, and methods of analysis provided in EN 71-9, EN 71-10 and EN 71-11 are suitable for soother holders. According to where they are applicable, they have been used in this European Standard. A Normative Annex has been included which contains translations of warning phrases into the main European languages. SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 5 1 Scope 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 connect a soother for babies and young children 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). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 71-3:1994, Safety of toys — Part 3: Migration of certain elements EN 71-10:2005, Safety of toys — Part 10: Organic chemical compounds — Sample preparation and extraction EN 71-11:2005, Safety of toys — Part 11: Organic chemical compounds — Methods of analysis EN 717-3, Wood-based panels — Determination of formaldehyde release — Part 3: Formaldehyde release by the flask method EN 1811, Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin EN 20105-A03, Textiles — Tests of colour fastness — Part A03: Grey scale for assessing staining
(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) SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 soother holder article that enables a soother to be secured to a child's garment etc. 3.2 soother article intended for satisfying the non-nutritive sucking need of children 3.3 garment fastener device for securing the soother holder to a child's garment etc. 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; SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 7 soother fastener; supplementary component(s). NOTE See Figure 1, Figure 2 and Figure 3.
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 SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 8
Key 1 garment fastener 2 strap 3 clothing fastener device 4 soother fastener 5 ventilation hole Figure 2 — Examples of soother holders SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 9
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 SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 10 5 Requirements 5.1 General requirements 5.1.1 General All materials shall comply with the requirements in this European Standard. 5.1.2 Integrity The components of the soother holder shall be so fixed that they cannot become detached when tested in accordance with the test methods given in 6.1.7. The soother holder shall have at least one permanently attached fastener (see 5.1.10). If there are two fasteners e.g. a garment fastener (see 3.3) and a soother fastener (see 3.4) then detachment of one of the fasteners shall not constitute a failure provided the detached fastener conforms to the requirements of 5.1.11. If there are supplementary components then detachment of these components shall not constitute a failure provided each detached supplementary component conforms to the requirements of 5.1.12.5. 5.1.3 Visual and tactile inspection The soother holder shall have no accessible sharp points, sharp edges or burrs. Safety pins are not allowed. 5.1.4 Holes 5.1.4.1 Finger traps (see 6.1.8) To avoid entrapment of fingers in any part of the soother holder, all accessible holes more than 10 mm deep shall not have an opening width between 5,5 mm and 12 mm, when tested in accordance with 6.1.8. This requirement only applies to components made of materials with a Shore A hardness of more than 60 IRHD. NOTE Circular holes not meeting this requirement present a risk of restricting circulation. Also, non- circular holes with acute V-shaped angles or inward facing angles, that are not well rounded, should be avoided. 5.1.4.2 Ventilation holes (see 3.9 and B.11) If any permanent or detachable fastener (see 5.1.10 and 5.1.11) or any permanent or detachable supplementary component (see 5.1.12.4 and 5.1.12.5) protrude past the base of guides 1 and 2 (see !Figure 16 and Figure 17)" when tested in accordance with 6.1.9 it shall be provided with ventilation holes as follows: at least 2 ventilation holes, having a combined total area of at least 40 mm2 and each allowing the unhindered passage of a 401,0− mm diameter rod, through the whole thickness of the material shall be provided, or one ventilation hole allowing the unhindered passage of a 121,00+ mm diameter rod, through the whole thickness of the material or an area of at least 115 mm2 shall be provided. SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 11 Any surface area encompassing a 25 mm diameter circle shall include at least one ventilation hole. Further holes (not ventilation holes) in any position, even if smaller, may be provided and shall comply with the requirements of 5.1.4.1. Ventilation holes not allowing the unhindered passage of a 121,00+ mm diameter rod shall comply with the requirements of 5.1.4.1. 5.1.5 Decoration Adhesive decals and labels shall not be attached to any part of the soother holder. NOTE Decorations may be moulded into or imprinted on the soother holder. 5.1.6 Length (see 6.1.3 and B.7) A soother holder shall have a maximum length of 220 mm when tested in accordance with 6.1.3. !If the strap contains a double strand for all or part of its length capable of forming a loop, as shown in
Figure 9, then that part of the strap forming a loop shall have a maximum length of 110 mm when tested in accordance with 6.1.3." 5.1.7 Strap width (see 6.1.4 and B.8) The minimum width of the strap shall be 6 mm when tested in accordance with 6.1.4. 5.1.8 Cords (see B.9) 5.1.8.1 Thickness (see 6.1.4.3) If any cord (see 3.11) is exposed either before or during the width tests, 6.1.4.1 and 6.1.4.2 then the minimum thickness shall be 1,5 mm when tested in accordance with 6.1.4.3. 5.1.8.2 Exposed cord length If any cord (see 3.11) (excluding a cord forming a fastener) is exposed either before or during the width tests, 6.1.4.1 and 6.1.4.2 then the maximum total length of exposed cord (including any cord used to connect a supplementary component) shall be 15 mm when tested in accordance with 6.1.4.4. 5.1.9 Maximum size of press studs, touch-and-close and similar devices Press studs, touch-and-close and similar devices shall not be wider than the width of the strap. 5.1.10 Permanent fasteners At least one fastener shall be permanently attached to the strap. Permanently attached means: fastener shall not be capable of being separated from the strap by undoing a clip, press stud, touch-and-close or similar device and no fastener or part of a fastener shall become detached when tested in accordance with 6.1.7. SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 12 When tested in accordance with 6.1.9 any permanent fastener protruding past the base of guides 1 and 2 (see !Figure 16 and Figure 17"), shall be provided with a ventilation hole or holes (see 5.1.4.2). If the permanent fastener is also permanently attached to a supplementary component then the test in accordance with 6.1.9 shall be carried out with the combined component. 5.1.11 Detachable fasteners When tested in accordance with 6.1.9 if detachable fasteners protrude past the base of guides 1 and 2 they shall not pass completely through guide 3. If detachable fasteners protrude past the base of guides 1 and 2 when tested in accordance with 6.1.9 they shall be provided with a ventilation hole or holes (see 5.1.4.2). If the detachable fastener is permanently attached to a supplementary component then the tests in accordance with 6.1.9 shall be carried out with the combined component. 5.1.12 Supplementary components 5.1.12.1 Attachment (see B12) Supplementary components may be permanently attached (see 5.1.12.4) or detachable (see 5.1.12.5). 5.1.12.2 Length (see 6.1.3 and B.7) The attachment of supplementary components to a soother holder shall not increase the maximum length of the soother holder to more than 220 mm, when measured according to 6.1.3. 5.1.12.3 Width (see 6.1.4 and B.8) The minimum width of the strap attaching any supplementary component to the soother holder shall be 6 mm when tested in accordance with 6.1.4. If the supplementary component is attached by means of a cord then the cord shall conform to the requirements of 5.1.8. 5.1.12.4 Supplementary components permanently attached to the strap or to the fasteners (see B.12) Permanently attached means: supplementary component shall not be capable of being separated from the strap or the fasteners by undoing a clip, press stud, touch-and-close or similar device and no supplementary component or part of a supplementary component shall become detached when tested in accordance with 6.1.7. All supplementary components permanently attached to either the strap or to a fastener shall be tested in accordance with 6.1.9 in combination with the component to which it is attached. When tested in accordance with 6.1.9 if the combined component protrudes past the base of guides 1 and 2, it shall be provided with a ventilation hole or holes (see 5.1.4.2). SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 13 5.1.12.5 Detachable supplementary components When tested in accordance with 6.1.9 if detachable supplementary components protrude past the base of guides 1 and 2 when they shall not pass completely through guide 3. If detachable supplementary components protrude past the base of guides 1 and 2 when tested in accordance with 6.1.9 they shall be provided with a ventilation holes or holes (see 5.1.4.2). All detachable supplementary components shall be tested in accordance with 6.1.5 and no part shall break, tear or separate during this test. 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. SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 14 Table 1 — Tests to be carried out on materials
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]. SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 15 NOTE Soother holders may include nickel containing or nickel coated parts, usually the garment fastener and/or connecting rivets and press studs. Nickel is a sensitizer which may give rise to an allergic reaction. 5.3.5 Colour fastness (see 6.2.3) Textiles and wooden parts shall be tested in accordance with 6.2.3. If colour fastness to water or to perspiration results is more than 4 on the grey scale as defined in EN 20105-A03 then these parts shall be subjected to the requirements of 5.3.8 (colourants) and 5.3.9 (primary aromatic amines). 5.3.6 Formaldehyde (see B.4) 5.3.6.1 Textile components (fabrics, strings, ribbons etc.) of the soother holder shall not contain free and hydrolyzed formaldehyde in excess of 30 mg/kg when tested in accordance with EN ISO 14184-1. 5.3.6.2 Wooden components of the soother holder shall not release formaldehyde in excess of 80 mg/kg when tested in accordance with EN 717-3. 5.3.7 Phthalate content (see B.13 and Annex C) When plastic components of the soother holder are tested in accordance with a validated method the total content of phthalates given in Table 3 shall not exceed 0,1 % (m/m). An example of a validated method is provided in Annex C (informative). Table 3 — Phthalates to be tested Compound CAS number Di-isononyl phthalate (DINP) 28553-12-0 Di-(2-ethylhexyl) phthalate (DEHP) 117-81-7 Di-n-octyl phthalate (DNOP) 117-84-0 Di-iso-decyl phthalate (DIDP) 26761-40-0 Butyl benzyl phthalate (BBP) 85-68-7 Di-butyl phthalate (DBP) 84-74-2
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. SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 16 Table 4 — Limits for Colourants (see B.5 and B.6) Colour Index Name CAS Number Limit Disperse Blue 1 2475-45-8 Action Limit Disperse Blue 3 2475-46-9 Action Limit Disperse Blue 106 12223-01-7 Action Limit Disperse Blue 124 61951-51-7 Action Limit Disperse Yellow 3 2832-40-8 Action Limit Disperse Orange 3 730-40-5 Action Limit Disperse Orange 37/76 12223-33-5 13301-61-6 Action Limit Disperse Red 1 2872-52-8 Action Limit Solvent Yellow 1 60-09-3 Action Limit Solvent Yellow 2 60-11-7 Action Limit Solvent Yellow 3 97-56-3 Action Limit Basic Red 9 569-61-9 Action Limit Basic Violet 1 8004-87-3 Action Limit Basic Violet 3 548-62-9 Action Limit Acid Red 26 3761-53-3 Action Limit Acid Violet 49 1694-09-3 Action Limit
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
SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 17 5.3.10 Monomers (see 6.2.6 and B.6) When tested in accordance with 6.2.6 the migration of monomers from plastic materials shall not exceed the limits given in Table 6. Table 6 — Monomers (migration) (see B.6) Compound CAS number Limit a Acrylamide 79-06-1 Action limit Bisphenol A 80-05-7 0,1 mg/l Formaldehyde 50-00-0 2,5 mg/l Phenol 108-95-2 15 mg/l Styrene 100-42-5 0,75 mg/l
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. SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 18 6.1.2 Order of testing for general and mechanical requirements All soother holders shall be examined in the order given in Figure 4 using the same sample for all tests.
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 SIST EN 12586:2008+A1:2011
EN 12586:2007+A1:2011 (E) 19 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
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