SIST EN 12586:2025

SLOVENSKI STANDARD
01-julij-2025
Nadomešča:
SIST EN 12586:2008+A1:2011
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: EN 12586:2025
ICS:
97.190 Otroška oprema Equipment for children
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 12586
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2025
EUROPÄISCHE NORM
ICS 97.190 Supersedes 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 European Standard was approved by CEN on 1 December 2024.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12586:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Description of a soother holder . 8
5 Test equipment and tolerances . 12
6 Mechanical requirements and test methods. 16
7 Chemical requirements and test methods (see B.9) . 29
8 Consumer packaging . 37
9 Product information . 37
10 Test report . 39
Annex A (normative) Warnings . 41
Annex B (informative) Rationales . 45
Annex C (informative) Good practice for visibility and legibility . 55
Bibliography . 58

European foreword
This document (EN 12586:2025) has been prepared by Technical Committee CEN/TC 252 “Child care
articles”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2025, and conflicting national standards shall
be withdrawn at the latest by April 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12586:2007+A1:2011.
EN 12586:2024 includes the following significant technical changes with respect to
EN 12586:2007+A1:2011:
— 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 elastomer, 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 with the 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 leather preservatives too.
— Annex B: The specific migration limits have been specified based on the migration scenario usually
applied in the childcare article standards drafted by TC 252 WG5, considering the allocated daily
intake, the body weight, and the likely exposure.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
EN 12586:2024 (E)
NOTE Information about interpretations of CEN TC 252 Standards can be found in the collection of
interpretation requests CEN/TR 16411:2022 [31].
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, 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, Türkiye and the
United Kingdom.
Introduction
Accidents caused by soothers are few and any resulting in the death of a child are 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 dual 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] (See
also part 7.1). Flame retardants are not included as they are regulated by REACH and Regulation (EU)
2019/1021 [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 marketing and use of biocidal products [3].
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].
It is also important that the product or its packaging bears a traceability marking (e.g. batch coding) to
enable traceability of the product through the supply chain.
EN 12586:2024 (E)
1 Scope
This document specifies safety requirements relating to materials, construction, performance,
packaging and labelling of soother holders.
NOTE 1 See B.1.
It includes test methods for the mechanical and chemical requirements specified.
This document covers products for children from birth to 36 months of age, alike the soothers to which
these items are connected to.
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 to any other object 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 products that a soother holder attaches to are not considered in this standard.
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.
NOTE 2 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+A1:2021, 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 71-12:2016, Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances
ISO 4593:1993, Plastics — Film and sheeting — Determination of thickness by mechanical scanning
EN 17394-2:2020, Textiles and textile products - Part 2: Safety of children’s clothing - Security of
attachment of buttons - Test method
CEN/TS 17394-3:2021, Textiles and textile products - Part 3: Safety of children’s clothing - Security of
attachment of metal mechanically applied press fasteners - Test method
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp
• IEC Electropedia: available at https://www.electropedia.org/
3.1
soother holder
article that consists of a soother fastener, a garment fastener and a connecting device in between, e.g. a
strap
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 for attaching the soother holder to garment or any other object
Note 1 to entry: Any other object 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
elements that connect the garment fastener and the soother fastener
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
3.5.4
beaded elements
components of various shapes used to cover the cord
EN 12586:2024 (E)
3.6
touch-and-close device
soother fastener element having fibre interlocking faces, which are secured when pressed together
3.7
press stud
soother fastener element with two parts that engage when pressed together
3.8
ventilation hole
any shape of hole that is large enough to allow sufficient passage of air to sustain life
Note 1 to entry: See B.7.
3.9
supplementary component
any part other than fasteners, press studs or touch-and-close devices, connecting devices, textile labels
and soothers, that is attached to the soother holder
3.10
outer packaging
any packaging used for storage of the product by a retailer, not including the packaging intended for
the consumer
4 Description of a soother holder
Figures 1 to 3 illustrate typical examples of different items of soother holders and their design features.
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
EN 12586:2024 (E)
Key
1 garment fastener
2 connecting device
3 soother fastener
6 ventilation hole
Figure 2 — Examples of soother holders or parts of soother holders
Key
3 soother fastener
7 supplementary component
Figure 3 — Examples of soother holders with supplementary components and soother holder
with beaded elements
EN 12586:2024 (E)
5 Test equipment and tolerances
5.1 Guides
Dimensions in millimetres
Figure 4 — Guide 1
Dimensions in millimetres
Figure 5 — Guide 2
EN 12586:2024 (E)
Dimensions in millimetres
Figure 6 — Guide 3
5.2 Test spheres and feeler gauge
Test spheres A, B, C shall be made from stainless steel of diameters given in Table 1.
Table 1 — Test sphere diameters
Test Diameter
sphere
mm
+01,
A
40,
−0
+0
B
55,
−01,
C +01,
−0
Dimensions in millimetres
Figure 7 — Feeler gauge
5.3 Impact mass
Dimensions in millimetres
Key
a radius (2 ± 0,5) mm
mass (1 ± 0,02) kg
area diameter (80 ± 2) 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;
EN 12586:2024 (E)
— 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
Soother holders shall be designed and manufactured to satisfy the best conditions of hygiene and
cleanliness. They shall be so constructed, and their materials selected so that in normal and foreseeable
use they will not produce mould.
Before starting the test series, the product shall be cleaned in accordance with the instructions given by
manufacturer in the instruction for use (9.4). The product shall not get damaged due to the cleaning
procedure.
All materials shall comply with the requirements in this document.
Each test series shall be carried out on a new sample unless otherwise stated (see 6.4.2.1). In case the
product failed one specific test, then take a new sample for performing further test.
Safety pins are not allowed, due to small parts, sharp points, and sharp edges.
Press studs, touch-and-close and similar devices shall not be wider than the width of the strap.
2 2 2 2
All magnetic parts used shall have a magnetic flux index less than 50 kG mm (0,5 T mm ) when
tested according to EN 71-1:2014+A1:2018 (see B.15).
Adhesive decals and labels intended to stay on the product during use are not allowed on any part of
soother holder. Decorations shall not be attached to any part of the soother holder by glue.
Button and coin batteries are not allowed, due to the severe health risk posed to small children if
inserted, swallowed, or ingested (see B.17).
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 9) shall not exceed
220 mm. If the length of a connecting device forms a closed loop by design (see Figure 13), e.g. double
strap, its length 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. At any adjustment of the length of the
loop the length of the 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 Figures 9.1, 9.2 and 9.3).
All parts of the soother holder that contribute to the length shall be considered in the most onerous
position. Attached supplementary components shall be orientated and adjusted in such a way to achieve
the longest length (see Figure 9). A force of (25 ± 2) N is applied holding both ends of the soother holder
to take the measurement (see Figures 9, 10 and 11).
If the strap contains a double strand for all or part of its length, then the length of any part containing a
loop shall be tested under a tensile force of (25 ± 2) N. If the strap also contains a single strand element
or another part in the form of a loop (see Figure 13) these may be removed before testing. Each part of
the strap containing a loop shall be tested in isolation from any other part.
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), 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 shall 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 or hook of 5 mm diameter shall be inserted into the opening of the hook or loop. The axis of the rod
or hook shall be at 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 ± 10) 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 Figure 9).
EN 12586:2024 (E)
Figure 9 — Measurement of soother holder length with different soother fasteners
Key
1 garment fastener
2 garment fastener
3 open press stud
4 open touch-and-close device
5 maximum length 220 mm
Figure 10 — Measurement of soother holder length when press studs or touch-and-close devices
are present
EN 12586:2024 (E)
Right side shows inclusion of supplementary component in the measurement.
Figure 11 — Example of the effect on soother holder length when a supplementary component
and a soother fastener in the form of a loop are present
6.3 Connecting device width/thickness
6.3.1 Strap and chain width (see B.4)
The minimum width of the strap shall be 6,0 mm when tested in accordance with 6.3.3.
The overall width of the chain shall be minimum 6,0 mm when tested in accordance with 6.3.3.
6.3.2 Cord thickness (see B.5)
The minimum thickness of any cord shall be 1,5 mm when tested in accordance with 6.3.3.
Any cord that can be exposed for less than 15 mm (see 6.3.3) shall have a minimum width of 1,5 mm
when tested in accordance with 6.3.3.
Any cord that can be exposed for more than 15 mm (see 6.3.3) shall have a minimum width of 6 mm
when tested in accordance with 6.3.3.
Cords used to form or are part of a soother fastener are excluded (see B.5).
Cords less than 6 mm thick shall be e.g. beaded or covered with other elements of an outer diameter of
min 6mm.
In all cases, several measurements shall be made in order to ascertain the minimum width.
6.3.3 Measurement of width or thickness
The measurement shall be made with a force of (25 ± 2) N applied along the connecting device, in a
vertical orientation.
For a chain or a beaded cord, the measurement shall apply to the overall width of a link or a bead (see
Figure 12).
In all cases, in order to determine the most onerous condition several measurements shall be made to
ascertain the minimum width.
EN 12586:2024 (E)
Key
1 cloth strap
2 chain strap
3 bead strap
4 minimum width 6 mm
Figure 12 — Measurement of strap width
Figure 13 — Example of an open loop created by the connecting device
6.4 Structural integrity
6.4.1 General requirement
The soother holder shall not present a choking hazard due to small parts. Parts intended to be detached
shall not fit entirely into the small parts cylinder (see EN 71-1:2014+A1:2018, 8.2) and shall not pass
entirely through Guide 3 (see Figure 6) when tested according to 6.6.2.
When tested in accordance with the subsequent requirements, no part of the soother holder shall break,
tear or separate. During the subsequent tests, separation of parts that are meant to be detached is not to
be considered a failure.
NOTE Parts meant to be detached are parts that can be reassembled in the original state without any damage.
At least one fastener shall be attached to the connecting device in such a way that it does not detach
when the tensile test according to 6.4.4 is applied (see B.8).
6.4.2 Impact resistance
6.4.2.1 General
The soother holder shall be tested in accordance with 6.4.2.2 and no part shall break, tear or separate
during this test. The tested soother holder shall, as far as applicable, be used in the subsequent tests.
NOTE All components of the soother holder are included in this test, including but not limited to soother
fastener, garment fastener, connecting device and supplementary components.
6.4.2.2 Test method
Each part of the soother holder shall be tested as follows:
Place the complete soother holder to be tested unsupported on a flat, horizontal steel surface. Drop a
metallic weight (see Figure 8) with a mass of (1 ± 0,02) kg, distributed over an area of diameter (80 ± 2)
mm and corners rounded R = (2 ± 0,5) 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 weight shall be vertically guided during its entire fall to ensure consistency in the
application of the test. The guidance system should, as far as possible, be friction-free. Each test shall be
conducted in an area encompassed by the diameter of the metallic weight. The test shall be carried out
5 times on each part of the same sample. As far as reasonably practicable the same impact area shall not
be impacted more than 5 times. The soother 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.
EN 12586:2024 (E)
The garment fastener of the product shall then be tested in accordance with 6.4.3.
NOTE Combinations of metal and PTFE have proven to have very low friction.
6.4.3 Durability of the garment fastener
6.4.3.1 General
The garment fastener shall be tested in accordance with 6.4.3.2 and no part shall break, tear or separate
during this test or the consecutive tensile strength test.
6.4.3.2 Test method
The jaws of the garment fastener which are designed to grip onto another article or onto clothing are
opened and closed repeatedly onto a test plate. This is followed by a tensile strength test.
Operate the mechanism designed to open and close the jaws of the garment fastener repeatedly for
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 14.
After this test the garment fastener shall be tested for tensile strength in accordance with 6.4.4.
Where magnets are used as the closing device, it shall be opened and closed 1000 times. The magnet
holder shall show no damage at the end of the following test procedure: The magnetic parts shall be
brought together until magnetic attraction assembles the parts as intended by the construction of the
product. The parts shall then be separated until all magnetic attraction ceases. Each assembly and
disassembly shall count as one cycle. It is acceptable for the testing to be automated or to be performed
manually.
Key
1 a 3 mm plate
Figure 14 — Some examples of opening and closing mechanisms (see 6.4.3.2)
6.4.4 Tensile strength
6.4.4.1 General
After the impact resistance test and the garment fastener durability test, the integrity of the soother
holder shall be tested in accordance with 6.4.4.2. For all following tests the same sample (same as in
6.4.2 and 6.4.3) shall be used. No part shall break, tear or separate.
Buttons and similar closing devices shall be tested according to EN 17394-2:2020.
Press studs shall be tested according to CEN/TS 17394-3:2021.
Touch and close devices identified to be grippable shall be tested in accordance with 6.4.4.2.
EN 12586:2024 (E)
The component is grippable if it can be gripped between thumb and forefinger, or the feeler gauge (see
Figure 7) can be inserted between the component and the underlying layer of the soother holder at an
angle between 0°and 10° from the surface using a force of (10 ± 1) N. If the gauge can be inserted more
than 2 mm, the component shall be considered grippable.
6.4.4.2 Test method
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 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.
For the touch and close devices that have been identified as grippable the tensile test shall be applied
accordingly. If the touch and close device separates completely, then the product fails the requirement.
If the touch and close device only partially separates and lengthens the soother holder after the tensile
test, then the length shall not exceed the 220 mm and 300 mm requirements per 6.2 of this document.
The following pairs of components shall be tested (non-exhaustive list depending on the design of the
soother holder):
1) garment fastener and far end of connecting device – connecting device fully extended (where
soother is attached by press studs etc. or touch-and-close devices);
2) soother fastener and garment fastener;
3) supplementary component and connecting device;
4) supplementary component and garment fastener;
5) supplementary component and 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 and at an angle of 90° to the orientation above as well.
Tensile tests shall be carried out on all the pairs of components (if included as part of the construction)-
by exerting the force along the length of the soother holder. For product that has a fastener which opens
during the test this shall not be regarded as a failure. The test shall be continued until (90 ± 5) N is
reached or the product disassembles itself from the test equipment without damage.
Where the soother fastener is manufactured as a separate item and intended by the manufacturer to be
detached from the connecting device 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.
6.5 Entrapments
6.5.1 Finger traps
6.5.1.1 General
Finger traps can restrict blood circulation and shall therefore be avoided.
6.5.1.2 Requirement
When tested in accordance with 6.5.1.3 there shall be no openings that allow test sphere B (see Table 1)
to enter and penetrate at least the complete size of test sphere B (5,5 mm), unless test sphere C (see
Table 1) enters the opening at least the same depth that test sphere B penetrated.
6.5.1.3 Test method
The opening to be tested shall be orientated so that the entry to the opening shall be horizontal. Place
test sphere B (see Table 1) on the hole so that its mass allows it to pass through the opening. If test
sphere B pass through the opening, check whether test sphere C (see Table 1) penetrates fully through
the opening.
This requirement only applies to components made of materials with a Shore A hardness of more than
60.
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, shall be avoided.
6.6 Ventilation holes (see B.6 and B.7)
6.6.1 General
If any permanent or detachable soother fastener, garment fastener or supplementary component
protrudes past the base of Guide 1 (see Figure 4) or past the base of Guide 2 (see Figure 5) when tested
in accordance with subclause 6.6.3 it shall be provided with ventilation as follows:
— at least 2 ventilation holes, having a combined total area of at least 40 mm and each ventilation
hole shall allow the unhindered passage of test sphere A in Table 1 (see 5.2) through the whole
thickness of the material using only the mass of the test sphere;
or
— one ventilation hole allowing the unhindered passage of test sphere C in Table 1 (see 5.2) through
the whole thickness of the material using only the mass of the test sphere;
or
— a ventilation area of minimum 115 mm .
Any permanently attached component (e.g. beads) which are not supplementary components but are
only part of the connecting device and cannot fully cover a 25 mm diameter do not require ventilation
holes (see Figure 15).
Any detachable component shall not pass Guide 3 (see Figure 6) and shall also be checked for
ventilation holes when detached from the product.
EN 12586:2024 (E)
6.6.2 Ventilation hole position
If ventilation holes are required, they shall be placed in such a way that no surface area within a 25 mm
diameter is left unventilated (see Figure 15). Ventilation shall meet the requirements of 6.6.1.
The product meets the requirement if a ventilation hole is at least partly inside of the 25 mm diameter
of the guide, or the 25 mm guide is not completely inside of the rim/edges/outside profile of the
product when tested in accordance with subclause 6.6.3.
Further holes (not ventilation holes) in any position, even if smaller, may be provided.
6.6.3 Test method
Three different guides are used for checking the size of the product and the possible requirement for
ventilation holes, although the basic method is the same for all guides (Guide 1 (see Figure 4), Guide 2
(see Figure 5) and Guide 3 (see Figure 6)).
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, this means any part that shows below the rim of the guide.
The test guide for 25mm diameter (see Figure 15) shall be applied to check the position of ventilation
holes.
Dimensions in millimetres
Figure 15 — Test guide for 25 mm diameter
Place the part to be tested (fastener or supplementary component) on a flat surface and position the
guide above it with the 25 mm diameter opening in a vertical position. Check whether any surface
encompassing a 25 mm diameter circle is unventilated. Check all sides of the product.
If a partial ventilation hole is marginal or requires confirmation, then a light source can be used from
the opposite side of the component to the guide and check if light shows inside the 25 mm diameter of
the guide. If it does, then this partial ventilation hole meets the requirement.
6.7 Laceration
6.7.1 General
All parts of the soother holder shall be assessed according to 6.7.2 in regard to present sharp edges and
points in order to see if there is any laceration hazard present.
All components of the soother holder shall be free from any accessible sharp points or edges and free of
flash and burrs, which could cause injuries.
6.7.2 Test method
All parts shall be assessed by visual and tactile examination. In case of doubt, apply test method given in
EN 71-1:2014+A1:2018, 8.11 and 8.12.
6.8 Suffocation hazard by packaging
6.8.1 General
The packaging shall be considered to present a suffocation hazard if material without air permeability is
used.
6.8.2 Requirement for packaging
Any plastic covering used for packaging with an area greater than 100 mm × 100 mm shall conform to
any of the following requirements:
a) have an average sheet thickness of 0,038 mm or more; or
b) be perforated with specified holes so that a minimum of 1 % of the area has been removed over any
area of 30 mm × 30 mm.
Plastic parts shall be tested according to 6.8.3.
6.8.3 Test method
Procedure:
— For plastic bags, cut along the seams without stretching the bag, so that two single sheets are
produced.
— Measure the thickness of any sheet at 10 equidistant points across the diagonal of any area having
dimensions of at least 100 mm × 100 mm and average the readings.
— Use an indicator dial gauge for the measurement capable of measuring thickness with an accuracy
of 1 µm according to ISO 4593:1993.
7 Chemical requirements and test methods (see B.9)
7.1 General
All materials shall comply with the requirements in this document.
Each test shall be carried out on a new sample. Before starting the test series, the product shall be
cleaned in accordance with the instructions given by manufacturer in the instruction for use (9.4). The
product shall not get damaged due to the cleaning procedure.
When soother holders contain parts manufactured from different materials or in different colours, all
parts shall be tested separately unless otherwise stated.
EN 12586:2024 (E)
Decorations shall be scraped off the part of the material on which they are applied. If scraping off is not
possible or the scraped off weight from one sample is less than 10 mg, the separate test for decorations
can be omitted. In this case decoration will be tested as part of the material on which it is printed. In
this case a new unscraped sample is required for the test.
Soother holders are childcare articles in prolonged contact with skin. As such the requirements of
REACH regarding Ni (entry 27) are applicable.
7.2 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 2 (see B.9.1).
For other materials not listed in the Table 2 the relevant chemical risks should be evaluated and shall
cover at least all the tests included in the table, as applicable. It is the responsibility of the manufacturer
to assess the risks and address the issues as required.
Table 2 — Tests to be carried out on materials
Material
7.5 and
Requirement and Test 7.3 7.4 7.6 7.8  7.7 7.11 7.12
7.6
Textiles x x x    x
Leather x x x x  7.10 x
Decorations, coatings a
x x x x  x  x
x
Wood x x x   7.9 x
Plastics a
x x x x  x
x
Silicone elastomer x x x    x x
Rubber and TPE a
x x x x  x x
x
Resin-bonded materials a
x x x x 7.9 x  x
x
a
It is recommended that the types of materials be disclosed to the test house so that the applicable tests can be
identified. If this information is not available, then the samples have to be tested for all monomers.
7.3 Certain elements (see B.10 and B.11)
7.3.1 Requirement
The migration of certain elements from all materials used in the manufacturing of soother holders shall
not exceed the limits given in Table 3 when tested in accordance with 7.3.2.
Certain elements
Colour fastness, first
action test
Colorants and PAA,
final action test
Primary Aromatic
Amines (PAA)
Monomers
Preservatives
Formaldehyde
Nitrosamines/
Nitrosatables
Solvent
Table 3 — Limits of element migration from soother holder materials
Element Limit
mg/kg
Aluminium Al 18750
Antimony Sb 375
Arsenic As 31
Barium Ba 12500
Boron B 10000
Cadmium Cd 11
Chromium Cr III 313
Chromium Cr VI a
0,006
Cobalt Co 88
Copper Cu 5188
Lead Pb 16
Manganese Mn 1875
Mercury Hg 63
Nickel Ni 175
Selenium Se 313
Strontium Sr 37500
Tin Sn 125000
Organic Tin 8
Zinc Zn 31250
a
If the result is below the limit of quantification of EN 71-3:2019+A1:2021, the sample is to be considered
passed. See B.11 Cr VI Limit Rationale.
7.3.2 Method for determination of the migration of certain elements
The method stated in EN 71-3:2019+A1:2021 shall be used for the determination of migration of
certain elements.
All parts shall be tested individually.
However, components manufactured from the same material but having different colours may be
...