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BS EN 1400:2013+A2:2018 Child use and care articles. Soothers for babies and young children. Safety requirements and test methods, 2019
- undefined
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Description of a soother
- 5 Test equipment [Go to Page]
- 5.1 Shield template
- 5.2 Test spheres
- 5.3 Indentor
- 5.4 Cutting board
- 5.5 Bite endurance jaws
- 5.6 Impact mass
- 5.7 Guides
- 6 General [Go to Page]
- 6.1 Tolerances for construction and mechanical properties
- 6.2 Order of tests for construction and mechanical properties
- 6.3 Preparation of samples for construction and mechanical tests [Go to Page]
- 6.3.1 Pre-treatment
- 6.3.2 Boiling
- 6.3.3 Conditioning
- 6.3.4 New samples
- 6.4 Preparation of samples for chemical tests [Go to Page]
- 6.4.1 General
- 6.4.2 Boiling
- 6.4.3 New samples
- 7 Printing and decals
- 8 Construction properties and tests [Go to Page]
- 8.1 General
- 8.2 Teat (see B.5) [Go to Page]
- 8.2.1 Requirements
- 8.2.2 Test method for effective penetration
- 8.3 Shield (see B.6) [Go to Page]
- 8.3.1 Requirements
- 8.3.2 Test method
- 8.4 Shield ventilation (see B.7) [Go to Page]
- 8.4.1 Requirements
- 8.4.2 Test Methods [Go to Page]
- 8.4.2.1 Minimum diameter
- 8.4.2.2 Minimum area
- 8.5 Ring (see B.8) [Go to Page]
- 8.5.1 Requirements
- 8.5.2 Test methods [Go to Page]
- 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
- 8.6 Plug (see B.10) [Go to Page]
- 8.6.1 Requirement
- 8.6.2 Test Method
- 8.7 Knobs, plugs and/or covers made from non-flexible materials (see B.11) [Go to Page]
- 8.7.1 Requirements
- 8.7.2 Test Method
- 8.8 Rings, knobs, plugs and/or covers made of flexible materials (see B.12) [Go to Page]
- 8.8.1 Requirement
- 8.8.2 Test method
- 8.9 Openings (see B.13) [Go to Page]
- 8.9.1 Requirement
- 8.9.2 Test method
- 9 Mechanical properties [Go to Page]
- 9.1 Impact resistance [Go to Page]
- 9.1.1 Requirements
- 9.1.2 Test method
- 9.2 Puncture resistance (see B.14) [Go to Page]
- 9.2.1 Requirements [Go to Page]
- 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 [Go to Page]
- 9.2.2.1 Puncture resistance of teat
- 9.2.2.2 Puncture resistance of knob made of flexible materials
- 9.3 Tear resistance (see B.15) [Go to Page]
- 9.3.1 Requirements [Go to Page]
- 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 [Go to Page]
- 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) [Go to Page]
- 9.4.1 Requirement
- 9.4.2 Test method
- 9.5 Bite endurance of elastomeric components (see B.17) [Go to Page]
- 9.5.1 Requirement
- 9.5.2 Test method
- 9.6 Rotation endurance (see B.18) [Go to Page]
- 9.6.1 Requirement
- 9.6.2 Test method
- 9.7 Integrity (see B.19) [Go to Page]
- 9.7.1 Requirements
- 9.7.2 Test methods [Go to Page]
- 9.7.2.1 General instructions for all tensile tests
- 9.7.2.2 Tensile test
- 9.7.2.3 Tensile tests for single components and pairs of components
- 10 Chemical requirements and test methods [Go to Page]
- 10.1 General (see B.20)
- 10.2 Materials
- 10.3 Migration of certain elements (see B.21) [Go to Page]
- 10.3.1 Requirement
- 10.3.2 Method for the determination of the migration of certain elements
- 10.3.3 Determination of the quantity of migrated elements
- 10.4 N-Nitrosamines and N-Nitrosatable substances release (see B.22) [Go to Page]
- 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) [Go to Page]
- 10.5.1 Requirements
- 10.5.2 Determination [Go to Page]
- 10.5.2.1 Principles
- 10.5.2.2 Apparatus and reagents for the determination of antioxidants and MBT
- 10.5.2.3 Reagents
- 10.5.2.4 Procedure
- 10.5.2.5 Calculation of MBT and Antioxidants
- 10.6 Bisphenol A release (see B.20.5, B.26 and Annex H) [Go to Page]
- 10.6.1 Requirement
- 10.6.2 Migration of Monomers including BPA
- 10.7 Colour Fastness (see B.27) [Go to Page]
- 10.7.1 Requirement
- 10.7.2 Determination of colour fastness
- 10.8 Volatile compounds content (see B.27) [Go to Page]
- 10.8.1 Requirement
- 10.8.2 Determination of volatile compounds content [Go to Page]
- 10.8.2.1 Apparatus
- 10.8.2.2 Method
- 10.8.2.3 Calculation of results
- 11 Teat protectors [Go to Page]
- 11.1 General (see B.29)
- 11.2 Visual/tactile
- 11.3 Size [Go to Page]
- 11.3.1 Requirement
- 11.3.2 Test method
- 11.4 Ventilation holes [Go to Page]
- 11.4.1 Requirements
- 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 [Go to Page]
- 11.7.1 Requirements
- 11.7.2 Test Method
- 12 Consumer packaging
- 13 Product information [Go to Page]
- 13.1 General
- 13.2 Purchase information [Go to Page]
- 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 [Go to Page]
- 13.3.1 General
- 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 [Go to Page]
- 13.4.1 Requirements
- 13.4.2 Text
- 13.4.3 Symbol
- 14 Test report
- Annex A (normative)Warnings
- Annex B (informative)Rationale [Go to Page]
- B.1 Introduction
- B.2 General
- B.3 Cleanliness (see 8.1)
- B.4 Preparation of samples [Go to Page]
- 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)
- B.6 Shield (see 8.3)
- B.7 Shield ventilation (see 8.4)
- 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)
- 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) [Go to Page]
- B.20.1 General
- 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
- B.20.5 Common migration rules
- B.21 Migration of certain elements (see 10.3)
- B.22 N-Nitrosamines and N-Nitrosatable substances release (see 10.4)
- B.23 Mercaptobenzothiazole (MBT) release (see 10.5)
- B.24 Antioxidant release (see 10.5)
- B.25 Formaldehyde release (see 10.5)
- B.26 Bisphenol A release (see 10.6)
- B.27 Colourants (see 10.7)
- B.28 Volatile compounds content (see 10.8)
- B.29 Teat protectors (see 11)
- B.30 #Cr VI Limit (see 10.3 new)
- Annex C (informative)Information for products resembling a soother [Go to Page]
- 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
- C.5 Specialised applications
- C.6 Medical devices
- Annex D (informative)Some examples of suitable fixing devices
- Annex E (informative)Soothers — Assessment of compliance with standard — Sampling plan and compliance levels for freshly manufactured samples [Go to Page]
- E.1 General
- E.2 Sampling
- E.3 Compliance level
- E.4 Test methods and procedure
- 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 [Go to Page]
- F.1 Apparatus
- F.2 Standards
- F.3 Column
- F.4 Detection
- F.5 Retention Times
- F.6 Preparation of standard solutions of MBT and antioxidants
- Annex G (informative)Graphical representation for determining puncture resistance of a teat
- Annex H (informative)A–deviations [Go to Page]
