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BS EN 1400:2013+A2:2018:2019 Edition

BS EN 1400:2013+A2:2018:2019 Edition

$215.11

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

Published By Publication Date Number of Pages
BSI 2019 90
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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].

PDF Catalog

PDF Pages PDF Title
2 undefined
7 1 Scope
2 Normative references
3 Terms and definitions
9 4 Description of a soother
13 5 Test equipment
5.1 Shield template
14 5.2 Test spheres
15 5.3 Indentor
5.4 Cutting board
16 5.5 Bite endurance jaws
17 5.6 Impact mass
18 5.7 Guides
20 6 General
6.1 Tolerances for construction and mechanical properties
21 6.2 Order of tests for construction and mechanical properties
22 6.3 Preparation of samples for construction and mechanical tests
6.3.1 Pre-treatment
6.3.2 Boiling
6.3.3 Conditioning
6.3.4 New samples
23 6.4 Preparation of samples for chemical tests
6.4.1 General
6.4.2 Boiling
6.4.3 New samples
7 Printing and decals
8 Construction properties and tests
8.1 General
8.2 Teat (see B.5)
8.2.1 Requirements
24 8.2.2 Test method for effective penetration
8.3 Shield (see B.6)
8.3.1 Requirements
8.3.2 Test method
27 8.4 Shield ventilation (see B.7)
8.4.1 Requirements
30 8.4.2 Test Methods
8.4.2.1 Minimum diameter
31 8.4.2.2 Minimum area
8.5 Ring (see B.8)
8.5.1 Requirements
32 8.5.2 Test methods
8.5.2.1 Effective penetration of ring
8.5.2.2 Width of ring
8.5.2.3 Size of opening in the ring
8.5.2.4 Collapse of ring
33 8.6 Plug (see B.10)
8.6.1 Requirement
34 8.6.2 Test Method
8.7 Knobs, plugs and/or covers made from non-flexible materials (see B.11)
8.7.1 Requirements
8.7.2 Test Method
35 8.8 Rings, knobs, plugs and/or covers made of flexible materials (see B.12)
8.8.1 Requirement
8.8.2 Test method
36 8.9 Openings (see B.13)
8.9.1 Requirement
8.9.2 Test method
37 9 Mechanical properties
9.1 Impact resistance
9.1.1 Requirements
9.1.2 Test method
38 9.2 Puncture resistance (see B.14)
9.2.1 Requirements
9.2.1.1 Puncture resistance of teat
9.2.1.2 Puncture resistance of knob made of flexible materials
9.2.2 Test methods
9.2.2.1 Puncture resistance of teat
40 9.2.2.2 Puncture resistance of knob made of flexible materials
9.3 Tear resistance (see B.15)
9.3.1 Requirements
9.3.1.1 Tear resistance of teat
9.3.1.2 Tear resistance of knob made of flexible materials
9.3.2 Test methods
9.3.2.1 Tear resistance of teat
9.3.2.2 Tear resistance of knob made from flexible materials
9.4 Knob, plug and/or cover retention (see B.16)
9.4.1 Requirement
9.4.2 Test method
41 9.5 Bite endurance of elastomeric components (see B.17)
9.5.1 Requirement
9.5.2 Test method
43 9.6 Rotation endurance (see B.18)
9.6.1 Requirement
9.6.2 Test method
9.7 Integrity (see B.19)
9.7.1 Requirements
9.7.2 Test methods
9.7.2.1 General instructions for all tensile tests
9.7.2.2 Tensile test
44 9.7.2.3 Tensile tests for single components and pairs of components
45 10 Chemical requirements and test methods
10.1 General (see B.20)
10.2 Materials
46 10.3 Migration of certain elements (see B.21)
10.3.1 Requirement
47 10.3.2 Method for the determination of the migration of certain elements
10.3.3 Determination of the quantity of migrated elements
48 10.4 N-Nitrosamines and N-Nitrosatable substances release (see B.22)
10.4.1 Requirement
10.4.2 Determination of N-Nitrosamines and N-Nitrosatable substances release
10.5 2-Mercaptobenzothiazole (MBT), Antioxidant and Formaldehyde release (see B.20.5 and B.23, B.24, B.25)
10.5.1 Requirements
49 10.5.2 Determination
10.5.2.1 Principles
10.5.2.2 Apparatus and reagents for the determination of antioxidants and MBT
50 10.5.2.3 Reagents
10.5.2.4 Procedure
10.5.2.5 Calculation of MBT and Antioxidants
51 10.6 Bisphenol A release (see B.20.5, B.26 and Annex H)
10.6.1 Requirement
10.6.2 Migration of Monomers including BPA
10.7 Colour Fastness (see B.27)
10.7.1 Requirement
10.7.2 Determination of colour fastness
10.8 Volatile compounds content (see B.27)
10.8.1 Requirement
10.8.2 Determination of volatile compounds content
10.8.2.1 Apparatus
52 10.8.2.2 Method
10.8.2.3 Calculation of results
53 11 Teat protectors
11.1 General (see B.29)
11.2 Visual/tactile
11.3 Size
11.3.1 Requirement
11.3.2 Test method
11.4 Ventilation holes
11.4.1 Requirements
54 11.4.2 Test method for ventilation holes in teat protectors
11.4.3 Test method for ventilation holes in combined product (soother plus teat protector)
11.5 Openings
11.6 Cup-shaped teat protectors
11.7 Impact Resistance
11.7.1 Requirements
11.7.2 Test Method
55 12 Consumer packaging
13 Product information
13.1 General
13.2 Purchase information
13.2.1 Visible at point of retail sale
13.2.2 Visible at point of internet sale or mail order
13.3 Instructions for use
13.3.1 General
56 13.3.2 Warnings in a set form and order
13.3.3 Warning not in set form
13.3.4 Warning if applicable
13.3.5 Other instructions for use
13.4 Supply chain information for products that contain vulcanised rubber
13.4.1 Requirements
57 13.4.2 Text
13.4.3 Symbol
14 Test report
59 Annex A (normative)Warnings
63 Annex B (informative)Rationale
B.1 Introduction
B.2 General
B.3 Cleanliness (see 8.1)
B.4 Preparation of samples
B.4.1 Pre-treatment (6.3.1)
B.4.2 Boiling (6.3.2 and 6.4.2)
B.5 Teat (see 8.2)
64 B.6 Shield (see 8.3)
B.7 Shield ventilation (see 8.4)
65 B.8 Ring (see 8.5)
B.9 Collapse of rings made of non-flexible material (see 8.5.1)
B.10 Plug (see 8.6)
B.11 Knob, plug and cover made of non-flexible materials (see 8.7)
B.12 Rings, knobs, plugs and/or covers made of flexible materials (see 8.8)
B.13 Openings (see 8.9)
B.14 Puncture resistance (see 9.2)
66 B.15 Tear resistance (see 9.3)
B.16 Knob, plug and/or cover retention (see 9.4)
B.17 Biting endurance of elastomeric components (see 9.5)
B.18 Rotation endurance (see 9.6)
B.19 Integrity (see 9.7)
B.20 Chemical requirements and test methods (see Clause 10)
B.20.1 General
67 B.20.2 Weight of a child mouthing the soother
B.20.3 Amount of material that can be bitten/scraped off a soother
B.20.4 Allocation of TDI
68 B.20.5 Common migration rules
B.21 Migration of certain elements (see 10.3)
70 B.22 N-Nitrosamines and N-Nitrosatable substances release (see 10.4)
B.23 Mercaptobenzothiazole (MBT) release (see 10.5)
71 B.24 Antioxidant release (see 10.5)
72 B.25 Formaldehyde release (see 10.5)
73 B.26 Bisphenol A release (see 10.6)
B.27 Colourants (see 10.7)
B.28 Volatile compounds content (see 10.8)
74 B.29 Teat protectors (see 11)
B.30 #Cr VI Limit (see 10.3 new)
75 Annex C (informative)Information for products resembling a soother
C.1 General
C.2 Resemble a soother but are not designed or do not function as a soother for children
C.3 Resemble a soother but having another minor function
C.4 Resemble a soother but having another major function
76 C.5 Specialised applications
C.6 Medical devices
77 Annex D (informative)Some examples of suitable fixing devices
80 Annex E (informative)Soothers — Assessment of compliance with standard — Sampling plan and compliance levels for freshly manufactured samples
E.1 General
E.2 Sampling
E.3 Compliance level
E.4 Test methods and procedure
81 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
F.1 Apparatus
F.2 Standards
F.3 Column
82 F.4 Detection
F.5 Retention Times
83 F.6 Preparation of standard solutions of MBT and antioxidants
85 Annex G (informative)Graphical representation for determining puncture resistance of a teat
86 Annex H (informative)A–deviations

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BS EN 1400:2013+A2:2018
$215.11