oSIST prEN 12586:2021

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

This European Standard specifies safety requirements relating to 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 and disconnect a soother for babies and young children with any other product are included in the scope of this European Standard. The safety requirements of these other products are not considered in this standard.
This European Standard is intended to provide safety requirements for soother holders. These are connecting devices with the holder at one end which retains the soother and the other end has a clasp that attaches to any other product e.g. 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 safety requirements for toys as stated in the Toy Directive 2009/48/EC [6] 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 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

Dieses Dokument legt sicherheitstechnische Anforderungen an Werkstoffe, Ausführung, Leistungsmerkmale, Verpackung und Kennzeichnung von Schnullerhaltern fest (siehe B.1).
Es enthält Prüfverfahren für die festgelegten mechanischen und chemischen Anforderungen.
Dieses Dokument soll sicherheitstechnische Anforderungen an Schnullerhalter bereitstellen. Jedes Produkt, das die Befestigung eines für Säuglinge und Kleinkinder vorgesehenen Schnullers mit einem beliebigen weiteren Produkt ermöglicht, ist in dem Anwendungsbereich erfasst. Der Schnullerhalter verfügt an je einem Ende über eine Halterung für den Schnuller, eine Befestigung am Kleidungsstück zum Anbringen an einem beliebigen anderen Produkt, z. B. an der Kleidung des Kindes, sowie ein Verbindungselement zwischen diesen Teilen. Die sicherheitstechnischen Anforderungen dieser anderen Produkte können in diesem Dokument nicht berücksichtigt werden.
Wenn einem Schnullerhalter ein bedeutender Spielwert zugeordnet wird, wird erwartet, dass der Schnullerhalter den sicherheitstechnischen Anforderungen an Spielzeug nach den Angaben in der Richtlinie 2009/48/EG über Spielzeug [6] ergänzend zu den in diesem Dokument angegebenen entspricht. Das Hinzufügen von Dekoren oder Befestigungselementen in Tierform führt nicht automatisch dazu, dass der Schnullerhalter als Spielzeug einzuordnen ist. Wenn Zweifel bestehen, ob der Schnullerhalter als Spielzeug einzuordnen ist, kann von einer für Spielzeug zuständigen benannten Stelle in der EU oder von der für Spielzeug zuständigen Behörde des Mitgliedstaates Rat eingeholt werden (siehe B.2).

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

Le présent document 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).
Il comprend des méthodes d’essai portant sur les exigences mécaniques et chimiques spécifiées.
Le présent document est destiné à fournir des exigences de sécurité pour les attaches-sucettes. Tous les produits permettant de fixer une sucette pour nourrissons et jeunes enfants à un autre produit entrent dans le domaine d’application du présent document. L’attache-sucette est munie, d’un côté, d’un dispositif de fixation pour la sucette et, de l’autre, d’une fixation côté vêtement qui s’attache à tout autre produit (par exemple le vêtement de l’enfant), ainsi que d’un dispositif de raccordement reliant ces éléments. Les exigences de sécurité de ces autres produits ne peuvent pas être prises en compte dans le présent document.
Si une attache-sucette est considérée comme ayant une valeur ludique significative, elle est censée satisfaire aux exigences de sécurité essentielles relatives aux jouets visées dans la Directive « Jouets » (2009/48/CE) [6] en plus des exigences spécifiées dans le présent document. L’ajout de décorations ou la présence de fixations en forme d’animaux ne classent pas automatiquement l’attache-sucette dans la catégorie jouets. En cas de doute sur la classification d’une attache-sucette comme jouet, 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) peut être demandé.

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

General Information

• Status: Not Published
• Public Enquiry End Date: 02-Jul-2021
• ICS: 97.190 - Equipment for children
• Technical Committee: OTR - Child use and care article
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 22-Apr-2021
• Due Date: 09-Sep-2021
• Completion Date: 15-Nov-2021
• 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: FprEN 12586 - Child care articles - Soother holder - Safety requirements and test methods

Relations

• Revised: SIST EN 12586:2008+A1:2011 - Child use and care articles - Soother holder - Safety requirements and test methods
• Effective Date: 01-Apr-2020
• Revised: SIST EN 12586:2008+A1:2011 - Child use and care articles - Soother holder - Safety requirements and test methods
• Effective Date: 18-Jan-2023
• Revised: SIST EN 12586:2008+A1:2011 - Child use and care articles - Soother holder - Safety requirements and test methods
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 12586:2021
01-junij-2021
Izdelki za otroke - Držalo dude - Varnostne zahteve in preskusne metode
Child care articles - Soother holder - Safety requirements and test methods
Artikel für Säuglinge und Kleinkinder - Schnullerhalter - Sicherheitstechnische
Anforderungen und Prüfverfahren

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

Ta slovenski standard je istoveten z: prEN 12586
ICS:
97.190 Otroška oprema Equipment for children
oSIST prEN 12586:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 12586:2021
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oSIST prEN 12586:2021
DRAFT
EUROPEAN STANDARD
prEN 12586
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2021
ICS 97.190 Will supersede EN 12586:2007+A1:2011
English Version
Child care articles - Soother holder - Safety requirements
and test methods

Articles de puériculture - Attache sucette - Exigences Artikel für Säuglinge und Kleinkinder - Schnullerhalter

de sécurité et méthodes d'essai - Sicherheitstechnische Anforderungen und
Prüfverfahren

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

CEN/TC 252.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 12586:2021 E

worldwide for CEN national Members.
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Contents Page

European foreword ...................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 6

4 Description of a soother holder ................................................................................................................. 8

5 Test equipment and tolerances ............................................................................................................... 12

5.1 Guides ................................................................................................................................................................ 12

5.2 Test spheres .................................................................................................................................................... 14

5.3 Impact mass .................................................................................................................................................... 15

5.4 Tolerances ....................................................................................................................................................... 15

6 Mechanical requirements and test methods....................................................................................... 15

6.1 General requirements ................................................................................................................................. 15

6.2 Length (see B.3) ............................................................................................................................................. 16

6.3 Width ................................................................................................................................................................. 19

6.4 Structural integrity ...................................................................................................................................... 19

6.5 Entrapments ................................................................................................................................................... 22

6.6 Ventilation holes ........................................................................................................................................... 22

6.7 Laceration ........................................................................................................................................................ 23

6.8 Suffocation hazard by packaging ............................................................................................................ 23

7 Chemical requirements and test methods (see B.9) ........................................................................ 24

7.1 General.............................................................................................................................................................. 24

7.2 Requirements by material ......................................................................................................................... 24

7.3 Certain elements (see B.10 and B.11).................................................................................................... 25

7.4 Colour fastness (see B.12) ......................................................................................................................... 27

7.5 Colourants (see B.12) .................................................................................................................................. 28

7.6 Primary aromatic amines (see B.12) ..................................................................................................... 28

7.7 Formaldehyde (see B.13) ........................................................................................................................... 29

7.8 Monomers (see B.14) ................................................................................................................................... 29

7.9 Wood preservatives ..................................................................................................................................... 29

7.10 Leather preservatives ................................................................................................................................. 30

7.11 Release of N-nitrosamines and N-nitrosatable substances ........................................................... 30

7.12 Solvent migration ......................................................................................................................................... 30

8 Consumer packaging ................................................................................................................................... 30

9 Product information .................................................................................................................................... 31

9.1 General.............................................................................................................................................................. 31

9.2 Purchase information.................................................................................................................................. 31

9.3 Warnings .......................................................................................................................................................... 31

9.4 Instructions for use ...................................................................................................................................... 32

9.5 Supply chain information for products that contain vulcanised rubber .................................. 32

10 Test report ....................................................................................................................................................... 33

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Annex A (normative) Warnings .............................................................................................................................. 34

Annex B (informative) Rationales ......................................................................................................................... 38

B.1 General ............................................................................................................................................................. 38

B.2 Relationship with the Toy Directive ...................................................................................................... 38

B.3 Length of soother holder (see 6.2) ......................................................................................................... 38

B.4 Strap width (see 6.3.1) ................................................................................................................................ 39

B.5 Cord width (see 6.3.2) ................................................................................................................................. 39

B.6 Guide tests and ventilation holes (see 6.6) ......................................................................................... 39

B.7 Ventilation holes (see 6.6) ......................................................................................................................... 41

B.8 Permanent attachment (see 6.4.1) ......................................................................................................... 41

B.9 Chemical requirements and test methods (see 7) ............................................................................ 42

B.10 Migration of certain elements (see 7.3) ............................................................................................... 43

B.11 Cr VI Limit (see 7.3) ..................................................................................................................................... 44

B.12 Colour Fastness, Colourants and Primary Aromatic Amines (see 7.4, 7.5, 7.6) ..................... 45

B.13 Formaldehyde (see 7.7).............................................................................................................................. 45

B.14 Monomers (see 7.8) ..................................................................................................................................... 46

B.15 Magnets (see 6.4.3.2) ................................................................................................................................... 46

B.16 Packaging (see 6.8) ...................................................................................................................................... 47

Annex C (informative) Good practice for visibility and legibility............................................................... 48

C.1 General ............................................................................................................................................................. 48

C.2 Warnings .......................................................................................................................................................... 48

C.3 Font .................................................................................................................................................................... 48

C.4 Multi-languages ............................................................................................................................................. 48

Annex ZA (informative) Relationship between this European Standard and the safety

requirements of Directive 2001/95/EC aimed to be covered ...................................................... 49

Bibliography ................................................................................................................................................................. 52

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European foreword

This document (prEN 12586:2021) has been prepared by Technical Committee CEN/TC 252 “Child care

articles”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 12586:2007+A1:2011.

In comparison with the previous edition, the following technical modifications have been made:

— The standard has been completely renewed and a new structure was given. A whole series of new

aspects had to be considered.

— The list of materials used currently for soother holders is wider than the list in the former edition,

therefore additional materials have been included (silicone, rubber, TPE, leather, resin-bonded

materials).

— Introduction: Double testing should be avoided for environmental protection reasons. Therefore,

substances regulated by REACH like Phthalates, Nickel are not included any more.

— 7.3: The list of chemical elements to be tested for migration of certain elements has been enlarged

to cover 19 elements in accordance to last amendment of Directive 2009/48/EC.

— 7.4: Colour fastness test was changed and split in first action and final action method.

— 7.7: Limits and test methods for Formaldehyde release from different materials have been revised

and modified and included in a separate paragraph. The test and the limit for Formaldehyde release

is set based on the pragmatic approach that independently of the material type the amount of

Formaldehyde migrating from the entire product into saliva simulant shall not exceed the health-

based limit.

— 7.8: Migration limits for BPA, Phenol have been revised and set based on the recent amendments of

Appendix C to Annex II of Directive 2009/48/EC.

— 7.9 and 7.10: The list of preservatives was enlarged to cover wood and leader preservatives too.

— Annex B: The specific migration limits have been defined based on the migration scenario usually

applied in the childcare article standards drafted by TC252 WG5, considering the allocated daily

intake, the body weight, and the likely exposure.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this

document.
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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.

The main aim of this document 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 document 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. If the soother holder, in addition to its

functional use, has a significant play value, it could also be considered as a toy.

Chemical hazards have been considered by the Technical Committee for all construction materials

normally encountered in soother holders. Where relevant, requirements have been derived and

included in this document. Restrictions for phthalates, for poly aromatic hydrocarbons (PAH) and for

the release of nickel have not been included in this document as they are regulated by REACH [1]. Flame

retardants are not included as they are regulated by REACH and Regulation (EC) No 1021/2019 [2] and

do not have any relevance to functional soother holders.

Products with claimed biocidal effect or intended biocidal action are falling under the scope of

Regulation (EU) No 528/2012 concerning the market and use of biocidal products [3].

It is considered that, for organic chemical compounds, the requirements, sample preparation and

extraction, and methods of analysis provided in EN 71-9:2005+A1:2007, EN 71-10:2005 and

EN 71-11:2005 are suitable for soother holders, except where stated otherwise.

A normative annex has been included which contains translations of warning phrases into the main

European languages.

It is recommended that manufacturers and suppliers operate to EN ISO 9001 for quality management

systems [4]. It is also recommended that laboratories operate to ISO/IEC 17025, General requirements

for the competence of testing and calibration laboratories [5].
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1 Scope

This document specifies safety requirements relating to materials, construction, performance,

packaging and labelling of soother holders (see B.1).
It includes test methods for the mechanical and chemical requirements specified.

This document is intended to provide safety requirements for soother holders. All products that allow

the attachment of a soother intended for babies and young children with any other product are included

in the scope. The soother holder has a holding device at one end for the soother, a garment fastener that

attaches to any other product, e.g. the child’s garment and a connecting device linking these parts. The

safety requirements of these other products cannot be considered in this document.

Where a soother holder is considered to have significant play value, the soother holder is expected to

meet the safety requirements for toys as stated in the Toy Directive 2009/48/EC [6] in addition to those

in this document. The addition of decorations or providing animal shaped fasteners does not

automatically make the soother holder a toy. Where there is doubt concerning the classification of a

soother holder as a toy, advice can 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 documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 71-1:2014+A1:2018, Safety of toys - Part 1: Mechanical and physical properties

EN 71-3:2019, Safety of toys - Part 3: Migration of certain elements

EN 71-9:2005+A1:2007, Safety of toys - Part 9: Organic chemical compounds - Requirements

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 71-12:2016, Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances

CEN/TR 16792:2014, Safety of children's clothing - Recommendations for the design and manufacture of

children's clothing - Mechanical safety
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
soother holder

article that consists of a soother fastener, a garment fastener and a connecting device in between, e.g. a

strap
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3.2
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.
3.3
garment fastener
device to attach and detach to any other product

Note 1 to entry: Any other product could be a stroller, car seat, plush product, etc.

3.4
soother fastener
device for attaching the soother holder to the soother
3.5 Connecting devices
3.5.1
cord

piece of slender, flexible material including monofilaments, woven and twisted cord, rope, and fibrous

materials commonly called string, normally having a circular cross section
Note 1 to entry: See B.5.
3.5.2
strap
connecting device made of flexible material with a non-circular cross section
3.5.3
chain
connecting device made of multiple interlinked parts
3.6
touch-and-close device
device having interlocking faces, which are secured when pressed together
3.7
press stud
device with two parts that engage when pressed together
3.8
ventilation hole
hole of any shape that includes a circular area of at least 4 mm diameter
Note 1 to entry: See B.7.
3.9
supplementary component

part that is attached to the soother holder other than fasteners, press studs or touch-and-close devices

and soothers and the part connecting the two fasteners
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4 Description of a soother holder

Figures 1 to 3 illustrate typical examples of different items of soother holders and their design features.

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Key
1 garment fastener 4 touch and close device
2 connecting device 5 press stud
3 soother fastener 6 ventilation hole

Figure 1 — Examples of soother holders or parts of soother holders assembled with soothers

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Key
1 garment fastener
2 connecting device
3 soother fastener
4 ventilation hole
Figure 2 — Examples of soother holders or parts of soother holders
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Key
1 soother fastener
2 supplementary component

Figure 3 — Examples of soother holders or parts of soother holders with supplementary

components
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5 Test equipment and tolerances
5.1 Guides
Dimensions in millimetres
Figure 4 — Guide 1
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Dimensions in millimetres
Figure 5 — Guide 2
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Dimensions in millimetres
Figure 6 — Guide 3
5.2 Test spheres
Key
1 edges broken
2 insertion edge radius
Figure 7 — Feeler gauge
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5.3 Impact mass
Dimensions in millimetres
Key
a radius (2 ± 0,5) mm
Figure 8 — Metallic weight
5.4 Tolerances
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: ±2° of the nominal angle;
— Duration of forces for durability tests: ±1 s;
— Duration of forces for static load tests: ±2 s.

Mechanical tests are often 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 affect

the results.
6 Mechanical requirements and test methods
6.1 General requirements
All materials shall comply with the requirements in this document.
Each test shall be carried out on a new sample unless otherwise stated.
Safety pins are not allowed.

Press studs, touch-and-close and similar devices shall not be wider than the width of the strap.

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All magnetic parts used, whether accessible or not, shall have a magnetic flux index less than

2 2
50 kg mm (0,5 T2mm2) when tested according to EN 71-1:2014+A1:2018 (see B.15).

Adhesive decals and adhesive labels shall not be attached to any part of the soother holder.

6.2 Length (see B.3)
6.2.1 Requirements

The length of the soother holder shall not exceed a certain length in order to avoid a strangulation

hazard.

When tested according to 6.2.2, the overall length of the soother holder shall not exceed 300 mm. The

length of the soother holder without the garment fastener (see example in Figure 8) shall not exceed

220 mm. If the length of a connecting device forms a closed loop by design (see Figure 11), e.g. double

strap, it shall not exceed 110 mm. If adjustment to the length of the Connecting Device is possible then

the largest loop shall be created for measurement. In any position the length of a soother holder

without the garment fastener shall not exceed 220 mm.
6.2.2 Test method

The principle is to determine the longest length of the soother holder, which might be a combination of

the connecting device, soother fastener and a supplementary component where present, with or

without the garment fastener (see Figure 10).

All parts of the soother holder that contribute to the length shall be considered in the most onerous

position. Attached components shall be orientated and adjusted in such a way to achieve the longest

length. A force of (25 ± 2) N is applied to both ends of the soother holder to take the measurement. (see

Figure 9).
If the soother fastener can be opened there are two ways of assessment.

If the soother fastener is made of flexible material, e.g. cord, loop or fabric (see Figure 1 A and B), open

the soother fastener and align it in the most onerous position to achieve the longest length. Apply

(25 ± 2) N to the extreme end of the soother fastener. Touch and close, press studs and similar devices

shell be opened.

Clamps or other devices shall hold the components securely during the test without giving rise to

damage which might affect the test result. Any results where such damage occurs shall be disregarded.

If the soother fastener is made of non-flexible material, e.g. a plastic hook, it shall be opened. A metal

rod of 5 mm diameter shall be inserted into the opening of the hook or loop. The axis of the rod shall be

in 90 degrees to the direction of the force (see Figure 9). A force of (25 ± 2) N shall be applied with a

speed of 200 mm/min. If the soother fastener slips off the rod or hook, the measurement shall be

repeated in closed position. If the (25 ± 2) N can be applied without slipping, then the maximum length

of the soother holder is the distance from attachment of the garment fastener to the utmost curve of the

outside of the soother fastener (see Figures 9L and 9M).
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Figure 9 — Measurement of soother holder length with different soother fasteners
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Right side shows inclusion of supplementary component in the measurement.

Figure 10 — Example of the effect on soother holder length when a supplementary component

and a soother fastener in the form of a loop are present
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Figure 11 —Example of an open loop created by the connecting device
6.3 Width
6.3.1 Strap width (see B.4)

The minimum width of the strap shall be 6,0 mm when tested in accordance with 6.3.3.

6.3.2 Cord width (see B.5)
The minimum width of a cord shall be 1,5 mm when tested in accord
...