Bsi bs en 01400 2013 + a1 2014

Key w half of shield width a-a major axis of shield Figure 15 — Example of the major axis of a shield Key a force applied to the teat b force applied to the ring or knob c force applie

BSI Standards Publication

Child use and care articles — Soothers for babies and young children — Safety requirements and test methods

This British Standard is the UK implementation of EN 1400:2013+A1:2014

It supersedes BS EN 1400:2013 which is withdrawn

The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the CEN amendment For example, text altered by CEN amendment A1 is indicated by 

The UK participation in its preparation was entrusted by Technical Committee CW/1, Safety of child use and child care products, to Subcommittee CW/1/4, Feeding, drinking and mouthing

A list of organizations represented on this subcommittee can be obtained on request to its secretary

This publication does not purport to include all the necessary provisions

of a contract Users are responsible for its correct application

© The British Standards Institution 2014

Published by BSI Standards Limited 2014ISBN 978 0 580 84086 9

Amendments/corrigenda issued since publication

30 June 2014 Implementation of CEN amendment A1:2014

EUROPÄISCHE NORM April 2014

English Version

Child use and care articles - Soothers for babies and young

children - Safety requirements and test methods

Articles de puériculture - Sucettes pour nourrissons et

jeunes enfants - Exigences de sécurité et méthodes d'essai Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Sicherheitstechnische

Anforderungen und Prüfverfahren

This European Standard was approved by CEN on 12 January 2013 and includes Amendment 1 approved by CEN on 25 February 2014 CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member

This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom

EUROPEAN COMMITTEE FOR STANDARDIZATION

C O M IT É E U R OP É E N D E N O RM A LIS A T IO N EURO PÄ ISC HES KOM ITE E FÜR NORM UNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2014 CEN All rights of exploitation in any form and by any means reserved Ref No EN 1400:2013+A1:2014 E

Contents Page

Foreword 3

Introduction 4

1 Scope 5

2 Normative references 5

3 Terms and definitions 5

4 Description of a soother 7

5 Test equipment 11

6 General 18

7 Printing and decals 21

8 Construction properties and tests 21

9 Mechanical properties 35

10 Chemical requirements and test methods 43

11 Teat protectors 51

12 Consumer packaging 53

13 Product information 53

14 Test report 55

Annex A (normative) Warnings 57

Annex B (informative) Rationale 61

Annex C (informative) Information for products resembling a soother 72

Annex D (informative) Some examples of suitable fixing devices 74

Annex E (informative) Soothers — Assessment of compliance with standard — Sampling plan and compliance levels for freshly manufactured samples 77

Annex F (informative) A suitable HPLC apparatus and method for determination of 2-Mercaptobenzothiazole (MBT) and antioxidants BHT, 2246, Cyanox 425, Wingstay L and Irganox 1520 79

Annex G (informative) Graphical representation for determining puncture resistance of a teat 83

Annex H (informative) A–deviations 84

Bibliography 85

Contents Page

Foreword 3

Introduction 4

1 Scope 5

2 Normative references 5

3 Terms and definitions 5

4 Description of a soother 7

5 Test equipment 11

6 General 18

7 Printing and decals 21

8 Construction properties and tests 21

9 Mechanical properties 35

10 Chemical requirements and test methods 43

11 Teat protectors 51

12 Consumer packaging 53

13 Product information 53

14 Test report 55

Annex A (normative) Warnings 57

Annex B (informative) Rationale 61

Annex C (informative) Information for products resembling a soother 72

Annex D (informative) Some examples of suitable fixing devices 74

Annex E (informative) Soothers — Assessment of compliance with standard — Sampling plan and compliance levels for freshly manufactured samples 77

Annex F (informative) A suitable HPLC apparatus and method for determination of 2-Mercaptobenzothiazole (MBT) and antioxidants BHT, 2246, Cyanox 425, Wingstay L and Irganox 1520 79

Annex G (informative) Graphical representation for determining puncture resistance of a teat 83

Annex H (informative) A–deviations 84

Bibliography 85

Foreword

This document (EN 1400:2013+A1:2014) 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 October 2014, and conflicting national standards shall be withdrawn at the latest by October 2014

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 This document includes Amendment 1 approved by CEN on 25 February 2014

This document supersedes !EN 1400:2013"

The start and finish of text introduced or altered by amendment is indicated in the text by tags !"

This document has been prepared under a mandate (M/264) given to CEN by the European Commission and the European Free Trade Association

This standard is linked to the General Product Safety Directive (GPSD) but no Annex ZA is needed because GPSD is not a New Approach Directive and does not include Essential Requirements to which such an annex should refer

The most significant change from EN 1400:2002 is that the three parts of that standard have been combined into one single document

In addition, improvements to several of the testing equipment have been made, including the shield template and probes for ventilation holes and finger traps

A number of common migration rules have been adopted as has the concept of allocating only a proportion of TDI's when setting migration limits

For the first time, requirements have been set for teat protectors as has supply chain information for products that contain vulcanised rubber

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom

Introduction

Soothers are widely used throughout Europe to satisfy non-nutritive sucking needs and to pacify children They are designed to be in the mouths of babies and young children for long periods Accidents, some of which have been fatal, have occurred in the past and a prime purpose of this standard is to reduce the risk of accidents occurring in the future It is stressed that this European Standard cannot eliminate all possible risks

to babies and young children using such a product and that parental or guardian control is of paramount importance It is essential that all warnings and instructions specified in this standard are given clearly by the manufacturer, to allow the consumer to ensure that the soother is used correctly and safely

This European Standard harmonises minimum safety requirements and test methods for soothers Most of the provisions have been taken from other existing national and European Standards

It is recommended that manufacturers and suppliers operate to EN ISO 9001, the standard for quality management systems [1] It is also recommended that laboratories operate to ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories [4]

In addition, it is recognised that some organisations require reference testing A suggested sampling plan and compliance levels for freshly manufactured soothers are provided in Annex E (informative) This procedure can be used as a voluntary type approval procedure

Latex protein allergy risk has not been included in this standard Nevertheless, provision for packaging information for soothers containing natural rubber has been made in this standard There is no published information that sensitisation is caused by soother teats In addition, there is an extremely low incidence of latex protein allergy among young children and babies However, the issue of subsequent allergic reaction from rubber teats will be reconsidered when further information becomes available

Phthalates have not been included in this standard because the use of phthalates in childcare articles is restricted by Annex XVII of REACH Regulation [5]

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

Introduction

Soothers are widely used throughout Europe to satisfy non-nutritive sucking needs and to pacify children

They are designed to be in the mouths of babies and young children for long periods Accidents, some of

which have been fatal, have occurred in the past and a prime purpose of this standard is to reduce the risk of

accidents occurring in the future It is stressed that this European Standard cannot eliminate all possible risks

to babies and young children using such a product and that parental or guardian control is of paramount

importance It is essential that all warnings and instructions specified in this standard are given clearly by the

manufacturer, to allow the consumer to ensure that the soother is used correctly and safely

This European Standard harmonises minimum safety requirements and test methods for soothers Most of the

provisions have been taken from other existing national and European Standards

It is recommended that manufacturers and suppliers operate to EN ISO 9001, the standard for quality

management systems [1] It is also recommended that laboratories operate to ISO/IEC 17025, General

requirements for the competence of testing and calibration laboratories [4]

In addition, it is recognised that some organisations require reference testing A suggested sampling plan and

compliance levels for freshly manufactured soothers are provided in Annex E (informative) This procedure

can be used as a voluntary type approval procedure

Latex protein allergy risk has not been included in this standard Nevertheless, provision for packaging

information for soothers containing natural rubber has been made in this standard There is no published

information that sensitisation is caused by soother teats In addition, there is an extremely low incidence of

latex protein allergy among young children and babies However, the issue of subsequent allergic reaction

from rubber teats will be reconsidered when further information becomes available

Phthalates have not been included in this standard because the use of phthalates in childcare articles is

restricted by Annex XVII of REACH Regulation [5]

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

languages

1 Scope

This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and product information for soothers

This European Standard is applicable to products that resemble or function as a soother Some soothers may

be marketed with other functions This standard is applicable to these products (some examples are given in Annex C)

This European Standard does not apply to products designed for specialist clinical medical applications, e.g those relating to Pierre-Robin Syndrome or premature babies (see Annex C)

The standard is not applicable to feeding teats Safety requirements and test methods for feeding teats are included in all parts of EN 14350 [2], [3]

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies

DIN 53160-1, Determination of the colourfastness of articles for common use — Part 1: Test with artificial

saliva

EN 71-1, Safety of toys — Part 1: Mechanical and physical properties

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

EN 71-11:2005, Safety of toys — Part 11: Organic chemical compounds — Methods of analysis

EN 12868, Child use and care articles — Methods for determining the release of Nitrosamines and

N-Nitrosatable substances from elastomer or rubber teats and soothers

EN 20A03, Textiles — Tests for colour fastness — Part A03: Grey scale for assessing staining (ISO

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply

3.1 soother

article which includes a teat and which is intended to satisfy the non-nutritive sucking need of children Note 1 to entry: Soothers are also known as pacifiers or babies' dummies

3.2 teat

part of the soother designed to be placed in the mouth

structure positioned adjacent to or on the shield to facilitate handling of the soother

Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached to the shield or plug

Note 2 to entry: See Figure 1

3.5

knob

structure positioned adjacent to or on the shield to facilitate gripping of the soother

Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached to the shield or plug

Note 2 to entry: See Figure 2

3.6

plug

device located within the neck of the teat that secures the teat to the shield

Note 1 to entry: See Figure 3

3.7

cover

device that prevents open access to the plug

Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached to the shield or plug

Note 2 to entry: See Figure 3

3.8

ventilation hole (see B.7)

any shape of hole in the shield or teat protector that is large enough to allow sufficient passage of air to sustain life

Note 1 to entry: See also 8.4.1 and 11.3.1

major axis of the soother

major axis of the soother goes at right angles to the shield and through the centre of the teat, where the teat enters the shield

structure positioned adjacent to or on the shield to facilitate handling of the soother

Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is

attached to the shield or plug

Note 2 to entry: See Figure 1

3.5

knob

structure positioned adjacent to or on the shield to facilitate gripping of the soother

Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is

attached to the shield or plug

Note 2 to entry: See Figure 2

3.6

plug

device located within the neck of the teat that secures the teat to the shield

Note 1 to entry: See Figure 3

3.7

cover

device that prevents open access to the plug

Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is

attached to the shield or plug

Note 2 to entry: See Figure 3

3.8

ventilation hole (see B.7)

any shape of hole in the shield or teat protector that is large enough to allow sufficient passage of air to

major axis of the soother

major axis of the soother goes at right angles to the shield and through the centre of the teat, where the teat

enters the shield

Note 1 to entry: See Figure 14

3.12 major axis of the shield

major axis of the shield is parallel to the longest dimension of the shield and in the middle of the width Note 1 to entry: See Figure 15

NOTE 1 Similar components are marked with the same number in Figures 1 to 4

NOTE 2 Some or all of the components may be manufactured from the same material which may result in the components not being separately distinguishable

NOTE 3 The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached to the shield or plug

7 sucking face of shield

8 rear face of shield

Figure 1 — Example of a soother with ring

7 sucking face of shield

8 rear face of shield

7 sucking face of shield

8 rear face of shield

Figure 3 — Example of a soother with plug and cover

7 sucking face of shield

8 rear face of shield

Figure 3 — Example of a soother with plug and cover

The dimensions shall be as shown in Figure 5

Dimensions in millimetres

Key

1 enlarged part section A – A

2 permanent marks for major and minor axes

Figure 5 — Shield template

5.2 Test spheres

Test spheres A, B, C and D, shall be made from stainless steel of diameters given in Table 1

Dimensions in millimetres

Key

1 enlarged part section A – A

2 permanent marks for major and minor axes

Figure 5 — Shield template

5.2 Test spheres

Test spheres A, B, C and D, shall be made from stainless steel of diameters given in Table 1

Table 1 — Test sphere diameters

The indentor is made from H13 high chrome tool steel or equivalent and hardened to a minimum of

50 Rockwell C and shall have dimensions as shown in Figure 6 All dimensions with a tolerance are machined

as in EN ISO 1302 to Ra 0,4 The larger diameter of the indentor has not been specified, as it should be of a size to fit into the equipment for applying the necessary force specified in the test methods

Figure 7 — Cutting board

5.5 Bite endurance jaws

The jaws are made from H13 high chrome tool steel or equivalent and hardened to (45 to 50) Rockwell C and shall have dimensions as shown in Figure 8

All dimensions with a tolerance are machined as in EN ISO 1302 to Ra 0,4 All dimensions for the top and bottom jaws are identical

Figure 7 — Cutting board

5.5 Bite endurance jaws

The jaws are made from H13 high chrome tool steel or equivalent and hardened to (45 to 50) Rockwell C and

shall have dimensions as shown in Figure 8

All dimensions with a tolerance are machined as in EN ISO 1302 to Ra 0,4 All dimensions for the top and

bottom jaws are identical

5.7 Guides

Guides 1, 2 and 3 with dimensions as shown in Figures 10, 11 and 12

Dimensions in millimetres

Figure 10 — Guide 1

Dimensions in millimetres

Figure 12 — Guide 3

6 General

6.1 Tolerances for construction and mechanical properties

Unless otherwise stated, the following tolerances apply:

— duration of forces for durability tests: ± 1 s;

— duration of forces for static load tests: ± 2 s

Dimensions in millimetres

Figure 12 — Guide 3

6 General

6.1 Tolerances for construction and mechanical properties

Unless otherwise stated, the following tolerances apply:

— duration of forces for durability tests: ± 1 s;

— duration of forces for static load tests: ± 2 s

The tests are described in terms of the application of forces Masses can however be used 1 kg mass may be used for 10 N force

Unless otherwise specified, the test forces may be applied by any suitable device which does not adversely affect the results

6.2 Order of tests for construction and mechanical properties

The tests shall be carried out in the order given in Table 2

Table 2 — Order of testing for construction and mechanical properties Order of

Testing Clause Test manufacturer prior to being Samples taken direct from

placed on the market

All Other samples

9.7.2.2

Tear resistance of teat followed by Tensile test

at right angles to the major axis (see Annex D, Figure D.2)

9.7.2.2

Bite endurance of elastomeric components

followed by Tensile test

at right angles to the major axis (see Annex D, Figure D.2)

7 9.7.2.3 Tensile tests for single components and pairs of components

Order of

Testing Clause Test manufacturer prior to being Samples taken direct from

placed on the market

All Other samples

at right angles to the major axis (see Annex D, Figure D.2)

9.7.2.2

Bite endurance of elastomeric components

followed by Tensile test

at right angles to the major axis (see Annex D, Figure D.2) Additional tests for soothers where a part rotates inside the teat

(See 9.6)

9.7.2.2

Rotation endurance followed by Tensile test along the major axis (see Annex D, Figure D.1)

6.3 Preparation of samples for construction and mechanical tests

6.3.1 Pre-treatment

Only samples taken directly from the manufacturer (see B.4.1) prior to being placed on the market shall be artificially aged for (7 days) ± 2 h in a cabinet oven with forced air circulation by means of a fan and a ventilation of three to ten changes per hour (as described as Method B in ISO 188) at a temperature of (70 ± 2) °C and conditioned as described in 6.3.3

6.3.2 Boiling

All samples shall be immersed in boiling water, to the requirements of EN ISO 3696, Grade 3, for (10 ± 1) min without touching the walls of the container and removed (see B.4.2) Afterwards, allow the samples to cool to room temperature

6.3.3 Conditioning

All samples shall be conditioned before the tests The conditioning of the samples shall be performed for at least 40 h in a temperature (23 ± 2) °C, and relative humidity (50 ± 5) % Samples shall remain in the conditioning atmosphere until the test is carried out The tests may be carried out in a non-conditioned room

Order of

Testing Clause Test manufacturer prior to being Samples taken direct from

placed on the market

All Other samples

at right angles to the major axis (see Annex D, Figure D.2)

9.7.2.2

Bite endurance of elastomeric components

followed by Tensile test

at right angles to the major axis (see Annex D, Figure D.2)

Additional tests for soothers where a part rotates inside the teat

(See 9.6)

9.7.2.2

Rotation endurance followed by

Tensile test along the major axis

(see Annex D, Figure D.1)

6.3 Preparation of samples for construction and mechanical tests

6.3.1 Pre-treatment

Only samples taken directly from the manufacturer (see B.4.1) prior to being placed on the market shall be

artificially aged for (7 days) ± 2 h in a cabinet oven with forced air circulation by means of a fan and a

ventilation of three to ten changes per hour (as described as Method B in ISO 188) at a temperature of

(70 ± 2) °C and conditioned as described in 6.3.3

6.3.2 Boiling

All samples shall be immersed in boiling water, to the requirements of EN ISO 3696, Grade 3, for (10 ± 1) min

without touching the walls of the container and removed (see B.4.2) Afterwards, allow the samples to cool to

room temperature

6.3.3 Conditioning

All samples shall be conditioned before the tests The conditioning of the samples shall be performed for at

least 40 h in a temperature (23 ± 2) °C, and relative humidity (50 ± 5) % Samples shall remain in the

conditioning atmosphere until the test is carried out The tests may be carried out in a non-conditioned room

6.3.4 New samples

New samples, preferably from the same batch, shall be used for each test (i.e samples used in one test shall

not be used in another test) or for each testing orientation, unless otherwise stated

6.4 Preparation of samples for chemical tests

6.4.1 General

The sample preparation (6.4.2) applies to all tests except N-Nitrosamines and N-Nitrosatable substances

release; see 10.4

Samples and test portions shall only be handled with suitable (for example, non-rubber) gloves and shall only

be stored in securely fastened, migration free containers and protected from the light

7 Printing and decals

There shall be no printing on the sucking face of the shield

Adhesive decals and labels shall not be attached to any part of the soother No decorations shall be attached

to any part of the soother by glue

A soother may be decorated, including moulded in, imprinting and printing Imprinting may include techniques such as stamping and laser etching No form of decoration shall be removed during the boiling stage (see 6.3.2)

8 Construction properties and tests

8.1 General

The soother shall be free from any sharp points or edges and free of flash and burrs

The soother shall have no removable parts other than a teat protector (see Clause 11)

Soothers have been known to become lodged in a child's mouth Attention should therefore be made to the design of all soother components to allow the assembled soother to be gripped as easily as possible, thereby facilitating removal of the soother from the child's mouth

Attention should also be made to the design of the soother to ensure that it may be cleaned as easily and as efficiently as possible (see B.3)

8.2.2 Test method for effective penetration

The effective penetration is the distance from the tip of the teat to where the teat enters the shield along the major axis, see Figure 13, and shall be measured using a suitable measuring device with an accuracy of 0,1 mm

Dimensions in millimetres

Figure 13 — Measurement of teat penetration

8.3 Shield (see B.6)

8.3.1 Requirements

The soother shall incorporate a shield

When tested in accordance with 8.3.2, the shield shall not pass through the shield template

At a crosshead speed of (100 ± 5) mm per min, apply a tensile force of (10 ± 0,5) N to the teat along the direction of the major axis of the soother, ensuring that there is no lateral movement causing a pendulum effect That is, the major axis of the soother shall always be aligned with the centre of the template throughout the test Maintain the load for (10 ± 0,5) s (see Figure 16 a))

Reverse the soother and repeat the test by pulling on the ring or the knob, using a suitable device (see Figure 16 b))

If the design or position of the soother ring or knob makes this impossible, or if the shield slides sideways through the template during the test then cut off the teat and repeat the test with the soother reversed over the template The force is applied from above through a rod centred in the hole left by the teat and along the major axis (see Figure 16 c)) The rod shall be a little larger in diameter than the size of the hole left by the teat

Dimensions in millimetres

Figure 13 — Measurement of teat penetration

8.3 Shield (see B.6)

8.3.1 Requirements

The soother shall incorporate a shield

When tested in accordance with 8.3.2, the shield shall not pass through the shield template

8.3.2 Test method

The shield template, see 5.1, shall be supported horizontally so that it remains firm and horizontal throughout

the test and there is no lateral movement of the shield template

NOTE It will assist the test if the shield is marked with its major and minor axes on both the sucking face and the rear

face These marked axes can then be lined up with the permanent marks on the shield template (see Figure 5)

Immerse the soother for at least 10 s in an aqueous solution of a wetting agent A 2 % (V/V) solution of

polyoxyethylene (20) sorbitan mono-oleate is suitable

Position the wet soother with the sucking face of the shield against the opening in the template; such that the

major axis of the soother goes through the intersection of the axes marked on the template (see Figure 14)

Orientate the soother, until the major axis of the shield (see Figure 15) is parallel to the major axis of the

template

At a crosshead speed of (100 ± 5) mm per min, apply a tensile force of (10 ± 0,5) N to the teat along the

direction of the major axis of the soother, ensuring that there is no lateral movement causing a pendulum

effect That is, the major axis of the soother shall always be aligned with the centre of the template throughout

the test Maintain the load for (10 ± 0,5) s (see Figure 16 a))

Reverse the soother and repeat the test by pulling on the ring or the knob, using a suitable device

(see Figure 16 b))

If the design or position of the soother ring or knob makes this impossible, or if the shield slides sideways

through the template during the test then cut off the teat and repeat the test with the soother reversed over the

template The force is applied from above through a rod centred in the hole left by the teat and along the

major axis (see Figure 16 c)) The rod shall be a little larger in diameter than the size of the hole left by the

teat

With some soothers (e.g full rubber or full silicone soothers) using this rod may not be possible In these instances a tube with an internal diameter of (15 ± 0/1) mm and a wall thickness of (1 ± 0,1) mm shall be used (see Figure 16d)) The teat shall be cut off as far as necessary to accommodate the tube

Key

a major axis of soother

b intersection of major and minor axes of shield template

c shield template (side view)

d shield template (top view)

Figure 14 — Major axis of soother in relation to the intersection of the axes marked on the shield

template

Key

w half of shield width

a-a major axis of shield

Figure 15 — Example of the major axis of a shield

Key

w half of shield width

a-a major axis of shield

Figure 15 — Example of the major axis of a shield

Key

a) force applied to the teat b) force applied to the ring or knob c) force applied from above through a rod centred in the hole left by the teat d) force applied from above through a tube

Figure 16 — Examples of positions of a soother on the shield template

8.4 Shield ventilation (see B.7)

means that the test sphere falls through the hole under its own weight, even if it touches the edges of the hole

or other parts of the soother, such as the ring

When tested in accordance with 8.4.2.2, each ventilation hole shall have a minimum area of 20 mm2

If any part of the soother, in any position, is equal to or more than 1,3 mm from the entrance to the hole then the hole shall be considered to be unobstructed and area measurement shall be made on the complete hole (see Figures 17 a) and Figure 17 b))

An obstructed hole is when any part of the soother, for example the ring, covers part of the hole in at least one position and when the obstruction is less than 1,3 mm at its closest point to the surface of the hole (see Figures 17 c) and Figure 17 d))

If a ring or other part of the soother obstructs a ventilation hole it shall be the unobstructed part of this ventilation hole that is tested

Additional holes in any position, even if smaller than ventilation holes, may be provided and shall comply with the requirements of 8.9

The centres of two of the ventilation holes shall be at least 15 mm apart and located either side of the minor axis of the shield, see Figure 18

The edges of two ventilation holes shall be at least 5 mm from the edge of the shield

The minimum diameter of a ventilation hole is 4mm, however it is recommended that ventilation holes are as large as possible, but consistent with the requirement for openings (see 8.9)

Certain types of ventilation holes have given rise to finger injuries Non-circular holes should avoid acute shaped angles or inward facing angles that are not well rounded, as both these features can lead to fingers becoming caught and injured See also 8.9

V-NOTE The shape of the edge of the shield and the size, shape and position of ventilation holes affect the ease with which the shield can be gripped in the event of the soother becoming lodged in a child’s mouth

means that the test sphere falls through the hole under its own weight, even if it touches the edges of the hole

or other parts of the soother, such as the ring

When tested in accordance with 8.4.2.2, each ventilation hole shall have a minimum area of 20 mm2

If any part of the soother, in any position, is equal to or more than 1,3 mm from the entrance to the hole then

the hole shall be considered to be unobstructed and area measurement shall be made on the complete hole

(see Figures 17 a) and Figure 17 b))

An obstructed hole is when any part of the soother, for example the ring, covers part of the hole in at least one

position and when the obstruction is less than 1,3 mm at its closest point to the surface of the hole

(see Figures 17 c) and Figure 17 d))

If a ring or other part of the soother obstructs a ventilation hole it shall be the unobstructed part of this

ventilation hole that is tested

Additional holes in any position, even if smaller than ventilation holes, may be provided and shall comply with

the requirements of 8.9

The centres of two of the ventilation holes shall be at least 15 mm apart and located either side of the minor

axis of the shield, see Figure 18

The edges of two ventilation holes shall be at least 5 mm from the edge of the shield

The minimum diameter of a ventilation hole is 4mm, however it is recommended that ventilation holes are as

large as possible, but consistent with the requirement for openings (see 8.9)

Certain types of ventilation holes have given rise to finger injuries Non-circular holes should avoid acute

V-shaped angles or inward facing angles that are not well rounded, as both these features can lead to fingers

becoming caught and injured See also 8.9

NOTE The shape of the edge of the shield and the size, shape and position of ventilation holes affect the ease with

which the shield can be gripped in the event of the soother becoming lodged in a child’s mouth

T top view showing examples of permissible measurement areas (shaded)

Figure 17 — Examples of obstructed and unobstructed holes in the shield

Dimensions in millimetres

Key

A minor axis

B major axis

C shaded area – no mandatory holes

Figure 18 — Examples of permissible positions for mandatory ventilation holes

8.4.2 Test Methods

8.4.2.1 Minimum diameter

The ventilation hole to be tested shall be orientated so that the entry to the hole shall be horizontal Any part of the soother whether it obstructs or does not obstruct the hole (see 8.4.1) shall be in its most onerous position Place test sphere A, see 5.2, on the hole so that its mass allows it to pass through the ventilation hole

Check whether the sphere passes completely through the hole

Dimensions in millimetres

Key

A minor axis

B major axis

C shaded area – no mandatory holes

Figure 18 — Examples of permissible positions for mandatory ventilation holes

8.4.2 Test Methods

8.4.2.1 Minimum diameter

The ventilation hole to be tested shall be orientated so that the entry to the hole shall be horizontal Any part of

the soother whether it obstructs or does not obstruct the hole (see 8.4.1) shall be in its most onerous position

Place test sphere A, see 5.2, on the hole so that its mass allows it to pass through the ventilation hole

Check whether the sphere passes completely through the hole

8.4.2.2 Minimum area

Measurement of the area of the hole may be made by any suitable method including graph paper, shadow technology etc Any part of the soother whether it obstructs or does not obstruct the hole (see 8.4.1) shall be

in its most onerous position

If the hole is unobstructed (any part of the soother, in any position, is equal to or more than 1,3 mm from the entrance to the hole) then the area measurement shall be made on the complete hole (see Figure 17 a) and Figure 17 b))

If the hole is obstructed then the measurement of area shall be made by including the area occupied by the Test Sphere A (12,57mm2) plus the area immediately surrounding Test Sphere A (see Figure 17 c) and Figure 17 d))

8.5 Ring (see B.8)

8.5.1 Requirements

A flow chart for ring requirements is shown in Table 3

Table 3 — Flow chart for ring requirements Rings made of non-flexible

materials Rings made of flexible materials

If rings made of non-flexible materials fail any of the requirements then treat as if

it is a knob made from flexible materials; see 8.7.1

Rings made of flexible materials shall comply with the requirements of 8.8.1

Rings made of non-flexible materials shall comply with the following requirements

— When tested in accordance with 8.5.2, the effective penetration, dimension A, which is the distance from the tip of the ring to the rear face of the shield, shall not be greater than 35 mm (see Figure 19)

— Dimension A shall not be greater than 1,4 times dimension B, the widest width of the ring, see Figure 19, 8.5.2.2 and B.8

— When tested in accordance with 8.5.2.3 the opening in the ring shall allow test sphere D, see 5.2, to pass through, see Figure 19

— When tested in accordance with 8.5.2.4 the ring shall collapse to 16 mm or less above the shield (see B.9)

Soothers fitted with rings that do not meet all the above requirements shall be treated as if they are fitted with

a knob made from non-flexible materials, see 8.7

Dimensions in millimetres

Key

A effective penetration of ring = Dimension ‘A’

B widest width of ring = Dimension ‘B’

1 test sphere D

Figure 19 — Ring dimension nomenclature 8.5.2 Test methods

8.5.2.1 Effective penetration of ring

The dimension A from the tip of the ring to the rear face of the shield, see Figure 19, along the major axis shall

be measured using a suitable measuring device with an accuracy of 0,1 mm

8.5.2.2 Width of ring

The dimension B, the maximum width of the ring, see Figure 19, shall be measured using a suitable measuring device with an accuracy of 0,1 mm

8.5.2.3 Size of opening in the ring

Position the ring 90° to the shield, see Figure 19, and check that test sphere D passes through the opening in the ring

8.5.2.4 Collapse of ring

Support the soother so that the movement of the ring is not restricted

Dimensions in millimetres

Key

A effective penetration of ring = Dimension ‘A’

B widest width of ring = Dimension ‘B’

1 test sphere D

Figure 19 — Ring dimension nomenclature 8.5.2 Test methods

8.5.2.1 Effective penetration of ring

The dimension A from the tip of the ring to the rear face of the shield, see Figure 19, along the major axis shall

be measured using a suitable measuring device with an accuracy of 0,1 mm

8.5.2.2 Width of ring

The dimension B, the maximum width of the ring, see Figure 19, shall be measured using a suitable

measuring device with an accuracy of 0,1 mm

8.5.2.3 Size of opening in the ring

Position the ring 90° to the shield, see Figure 19, and check that test sphere D passes through the opening in

the ring

8.5.2.4 Collapse of ring

Support the soother so that the movement of the ring is not restricted

Apply a (10 ± 0,5) N force along the major axis of the ring through a test plate as shown in Figure 20 Measure the distance between the rear face of the shield and the face of the test plate along the major axis of the soother, as shown in Figure 20, using a suitable measuring device with an accuracy of 0,1 mm

If necessary, the ring shall be offset slightly from the 90° position, before applying the force, to ensure it does not lock in the 90° position

Dimensions in millimetres

Key

1 position of ring following application of the 10 N force

2 test plate

3 rear face of shield along the major axis

Figure 20 — Collapse of ring measurement

8.6 Plug (see B.10)

8.6.1 Requirement

A plug shall not project more than 3 mm beyond the sucking face of the shield, see Figure 21

Requirement 8.7.1 shall also apply to a ring made of non-flexible materials that does not meet requirement 8.5.1

8.7.2 Test Method

The distance from the tip of the knob, plug or cover to the shield template (see 5.1), down the central axis, see Figure 21, shall be measured using a suitable measuring device with an accuracy of 0,1 mm The thickness of the shield template shall be added to the length measured to give the effective projection The knob, plug and/or cover shall be tested in all orientations about the major axis of the soother relative to the intersection of the major and minor axes of the shield template

Carefully cut off the teat If the plug projects beyond the sucking face of the shield, measure from the end of

the plug to the sucking face of the shield using a suitable device with an accuracy of 0,1 mm

8.7 Knobs, plugs and/or covers made from non-flexible materials (see B.11)

8.7.1 Requirements

A knob, plug or cover made from non-flexible materials, whichever projects furthest beyond the rear face of

the shield, shall not be less than 10 mm and not more than 16 mm, see Figure 22, unless the soother is fitted

with a ring that meets requirement 8.5.1

Requirement 8.7.1 shall also apply to a ring made of non-flexible materials that does not meet requirement

8.5.1

8.7.2 Test Method

The distance from the tip of the knob, plug or cover to the shield template (see 5.1), down the central axis,

see Figure 21, shall be measured using a suitable measuring device with an accuracy of 0,1 mm The

thickness of the shield template shall be added to the length measured to give the effective projection The

knob, plug and/or cover shall be tested in all orientations about the major axis of the soother relative to the

intersection of the major and minor axes of the shield template

g thickness of shield template

M major axis of soother

Figure 22 — Measurement of effective penetration of knob, plug and/or cover made from non-flexible

materials using the shield template

8.8 Rings, knobs, plugs and/or covers made of flexible materials (see B.12)

8.8.1 Requirement

If made of flexible materials, the effective penetration of the ring knob, plug and/or cover shall not be less than

10 mm and not more than 35 mm when tested in accordance with 8.8.2

8.8.2 Test method

The distance from the tip of the ring, knob, plug and/or cover to the shield template (see 5.1), down the central axis, see Figure 23, shall be measured using a suitable measuring device with an accuracy of 0,1 mm The thickness of the shield template shall be added to the length measured to give the overall effective penetration length The ring, knob, plug and/or cover shall be tested in all orientations about the major axis of the soother relative to the intersection of the major and minor axes of the shield template

g thickness of shield template

M major axis of the soother

Figure 23 — Measurement of effective penetration of ring, knob, plug and/or cover made of flexible

materials using the shield template

8.9 Openings (see B.13)

8.9.1 Requirement

When tested in accordance with 8.9.2, there shall be no openings that allow test sphere B, see 5.2, to enter and penetrate at least the complete size of test sphere B (5,5 mm), unless test sphere C, see 5.2, enters the opening at least the same depth that test sphere B penetrated

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 Non-circular holes with acute V-shaped angles or inward facing angles that are not well rounded are to be avoided

8.9.2 Test method

The opening to be tested shall be orientated so that the entry to the opening is horizontal Place test sphere C, see 5.2, on the hole so that its mass allows it to pass through the opening If test sphere C does not pass through any opening, check whether test sphere B, see 5.2, enters 5,5 mm into the opening This test shall be repeated from the other side of the opening

g thickness of shield template

M major axis of the soother

Figure 23 — Measurement of effective penetration of ring, knob, plug and/or cover made of flexible

materials using the shield template

8.9 Openings (see B.13)

8.9.1 Requirement

When tested in accordance with 8.9.2, there shall be no openings that allow test sphere B, see 5.2, to enter

and penetrate at least the complete size of test sphere B (5,5 mm), unless test sphere C, see 5.2, enters the

opening at least the same depth that test sphere B penetrated

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 Non-circular holes with

acute V-shaped angles or inward facing angles that are not well rounded are to be avoided

8.9.2 Test method

The opening to be tested shall be orientated so that the entry to the opening is horizontal Place test sphere C,

see 5.2, on the hole so that its mass allows it to pass through the opening If test sphere C does not pass

through any opening, check whether test sphere B, see 5.2, enters 5,5 mm into the opening This test shall be

repeated from the other side of the opening

it is practical, each impact carried out with the soother in a different stable orientation, see Figure 24

NOTE To align the impact mass before dropping, a ring just bigger than the diameter of the impact mass clamped at

a corresponding height to a retort stand has been found to be useful when carrying out this test

Dimensions in millimetres

Key

A impact mass centre line

B steel surface

Figure 24 — Examples of positions of the soother for the impact test

The subsequent tensile test, 9.7.2.2, shall be conducted along the major axis of the soother For a soother with a ring, apply the force between the ring and the teat For a soother with a knob which can be gripped, the force shall be applied between the knob and the teat For a soother with a plug, cover or knob, which cannot

be held by a fixture device, the force shall be applied between the shield and the teat

9.2 Puncture resistance (see B.14)

9.2.1 Requirements 9.2.1.1 Puncture resistance of teat

When tested in accordance with 9.2.2.1 a force greater than 30 N shall be required to cut completely through one wall of the teat, or for a solid teat through the whole of the teat

9.2.1.2 Puncture resistance of knob made of flexible materials

When tested in accordance with 9.2.2.2 soothers fitted with a knob made of flexible materials, shall require a force greater than 30 N to cut completely through one wall of the knob, or for a solid knob made of flexible materials, through the whole of the knob

9.2.2 Test methods

9.2.2.1 Puncture resistance of teat

Before use, the tip of the indentor, see 5.3, shall be inspected visually for any damage such as burrs or chips Only undamaged indentors shall be used as otherwise the results of the test will be affected

Without pulling, cut off the teat at right angles to the major axis from the complete soother as close as possible

to the shield and place the teat on the cutting board, see 5.4 and Figure 25

Dimensions in millimetres

Key

a indentor (see 5.3)

b teat

c cutting board (see 5.4)

d stop for cut edge of teat

Figure 25 — Positioning of indentor on the teat

Place the indentor, see 5.3, with the 3 mm edge of the indentor centred over and at right angles to the major axis of the teat and (5 ± 0,5) mm from the cut edge of the teat using the markings on the cutting board, see 5.4

9.2.1.2 Puncture resistance of knob made of flexible materials

When tested in accordance with 9.2.2.2 soothers fitted with a knob made of flexible materials, shall require a

force greater than 30 N to cut completely through one wall of the knob, or for a solid knob made of flexible

materials, through the whole of the knob

9.2.2 Test methods

9.2.2.1 Puncture resistance of teat

Before use, the tip of the indentor, see 5.3, shall be inspected visually for any damage such as burrs or chips

Only undamaged indentors shall be used as otherwise the results of the test will be affected

Without pulling, cut off the teat at right angles to the major axis from the complete soother as close as possible

to the shield and place the teat on the cutting board, see 5.4 and Figure 25

Dimensions in millimetres

Key

a indentor (see 5.3)

b teat

c cutting board (see 5.4)

d stop for cut edge of teat

Figure 25 — Positioning of indentor on the teat

Place the indentor, see 5.3, with the 3 mm edge of the indentor centred over and at right angles to the major

axis of the teat and (5 ± 0,5) mm from the cut edge of the teat using the markings on the cutting board, see

of maximum load

The force shall be applied at right angles to the cutting board using a tensile-testing machine

For solid teats there is only one wall and a piece of similar material to the teat should be placed under the teat

9.2.2.2 Puncture resistance of knob made of flexible materials

If the soother is fitted with a knob made of flexible materials repeat the puncture resistance test on the knob in

a similar manner to that described in 9.2.2.1

For solid knobs made of flexible materials there is only one wall and a piece of similar material to the flexible knob should be placed under the flexible knob

9.3 Tear resistance (see B.15)

9.3.1 Requirements 9.3.1.1 Tear resistance of teat

When tested in accordance with 9.3.2.1 the teat shall not break or separate during the subsequent tensile test

in accordance with 9.7.2.2

9.3.1.2 Tear resistance of knob made of flexible materials

If the soother is fitted with a knob made of flexible materials, when tested in accordance with 9.3.2.2 the knob shall not break or separate during the tensile test in accordance with 9.7.2.2

9.3.2 Test methods 9.3.2.1 Tear resistance of teat

Using a complete new soother sample, place the indentor, see 5.3, with the 3 mm edge of the indentor centred over and at right angles to the major axis of the soother and (7,5 ± 0,5) mm from where the teat enters the shield in the sucking face of the shield

Apply a load ensuring that the indentor cuts completely through the teat and approximately 1 mm into an undamaged area of a cutting board, see 5.4 When assessing solid teats, if the indentor has not cut through with a force of 300 N, stop this test and conduct the tensile test in accordance with 9.7.2.2

The subsequent tensile test, 9.7.2.2, with the teat at right angles to the major axis of the soother, shall be conducted with the clamp applied to the teat at a distance of (12 ± 2) mm from the shield and with the shield attached to a suitable fixture !(see Annex D)" The clamp holding the teat shall not cover or come into contact with the punctured holes

9.3.2.2 Tear resistance of knob made from flexible materials

If the soother is fitted with a knob made from flexible materials, repeat the tear resistance test on the knob in a similar manner to that described in 9.3.2.1

9.4 Knob, plug and/or cover retention (see B.16)

in the soother support in order to achieve a good fit on the rear face of the shield, see Figure 26

Cut the tip off the teat at (5 to 10) mm from the teat/shield junction Place a 5 mm diameter rod with a flat end into the teat until it rests on the plug or the combined plug and cover Apply a force of (90 ± 5) N at a crosshead speed of (10 ± 1) mm/min and maintain for (10 ± 0,5) s

If the soother is fitted with a separate plug and knob or cover then all parts shall be tested Apply the force to the underside of the knob or cover e.g by drilling a hole in the centre of the plug to allow access for the test rod, or by such other means as the design of the soother might allow