{"id":341692,"date":"2024-10-19T23:57:41","date_gmt":"2024-10-19T23:57:41","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-14002013a22018\/"},"modified":"2024-10-25T23:10:41","modified_gmt":"2024-10-25T23:10:41","slug":"bs-en-14002013a22018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-14002013a22018\/","title":{"rendered":"BS EN 1400:2013+A2:2018"},"content":{"rendered":"

This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and product information for soothers.<\/p>\n

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).<\/p>\n

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).<\/p>\n

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].<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
7<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
9<\/td>\n4 Description of a soother <\/td>\n<\/tr>\n
13<\/td>\n5 Test equipment
5.1 Shield template <\/td>\n<\/tr>\n
14<\/td>\n5.2 Test spheres <\/td>\n<\/tr>\n
15<\/td>\n5.3 Indentor
5.4 Cutting board <\/td>\n<\/tr>\n
16<\/td>\n5.5 Bite endurance jaws <\/td>\n<\/tr>\n
17<\/td>\n5.6 Impact mass <\/td>\n<\/tr>\n
18<\/td>\n5.7 Guides <\/td>\n<\/tr>\n
20<\/td>\n6 General
6.1 Tolerances for construction and mechanical properties <\/td>\n<\/tr>\n
21<\/td>\n6.2 Order of tests for construction and mechanical properties <\/td>\n<\/tr>\n
22<\/td>\n6.3 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 <\/td>\n<\/tr>\n
23<\/td>\n6.4 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 <\/td>\n<\/tr>\n
24<\/td>\n8.2.2 Test method for effective penetration
8.3 Shield (see B.6)
8.3.1 Requirements
8.3.2 Test method <\/td>\n<\/tr>\n
27<\/td>\n8.4 Shield ventilation (see B.7)
8.4.1 Requirements <\/td>\n<\/tr>\n
30<\/td>\n8.4.2 Test Methods
8.4.2.1 Minimum diameter <\/td>\n<\/tr>\n
31<\/td>\n8.4.2.2 Minimum area
8.5 Ring (see B.8)
8.5.1 Requirements <\/td>\n<\/tr>\n
32<\/td>\n8.5.2 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 <\/td>\n<\/tr>\n
33<\/td>\n8.6 Plug (see B.10)
8.6.1 Requirement <\/td>\n<\/tr>\n
34<\/td>\n8.6.2 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 <\/td>\n<\/tr>\n
35<\/td>\n8.8 Rings, knobs, plugs and\/or covers made of flexible materials (see B.12)
8.8.1 Requirement
8.8.2 Test method <\/td>\n<\/tr>\n
36<\/td>\n8.9 Openings (see B.13)
8.9.1 Requirement
8.9.2 Test method <\/td>\n<\/tr>\n
37<\/td>\n9 Mechanical properties
9.1 Impact resistance
9.1.1 Requirements
9.1.2 Test method <\/td>\n<\/tr>\n
38<\/td>\n9.2 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 <\/td>\n<\/tr>\n
40<\/td>\n9.2.2.2 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 <\/td>\n<\/tr>\n
41<\/td>\n9.5 Bite endurance of elastomeric components (see B.17)
9.5.1 Requirement
9.5.2 Test method <\/td>\n<\/tr>\n
43<\/td>\n9.6 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 <\/td>\n<\/tr>\n
44<\/td>\n9.7.2.3 Tensile tests for single components and pairs of components <\/td>\n<\/tr>\n
45<\/td>\n10 Chemical requirements and test methods
10.1 General (see B.20)
10.2 Materials <\/td>\n<\/tr>\n
46<\/td>\n10.3 Migration of certain elements (see B.21)
10.3.1 Requirement <\/td>\n<\/tr>\n
47<\/td>\n10.3.2 Method for the determination of the migration of certain elements
10.3.3 Determination of the quantity of migrated elements <\/td>\n<\/tr>\n
48<\/td>\n10.4 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 <\/td>\n<\/tr>\n
49<\/td>\n10.5.2 Determination
10.5.2.1 Principles
10.5.2.2 Apparatus and reagents for the determination of antioxidants and MBT <\/td>\n<\/tr>\n
50<\/td>\n10.5.2.3 Reagents
10.5.2.4 Procedure
10.5.2.5 Calculation of MBT and Antioxidants <\/td>\n<\/tr>\n
51<\/td>\n10.6 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 <\/td>\n<\/tr>\n
52<\/td>\n10.8.2.2 Method
10.8.2.3 Calculation of results <\/td>\n<\/tr>\n
53<\/td>\n11 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 <\/td>\n<\/tr>\n
54<\/td>\n11.4.2 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 <\/td>\n<\/tr>\n
55<\/td>\n12 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 <\/td>\n<\/tr>\n
56<\/td>\n13.3.2 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 <\/td>\n<\/tr>\n
57<\/td>\n13.4.2 Text
13.4.3 Symbol
14 Test report <\/td>\n<\/tr>\n
59<\/td>\nAnnex A (normative)Warnings <\/td>\n<\/tr>\n
63<\/td>\nAnnex 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) <\/td>\n<\/tr>\n
64<\/td>\nB.6 Shield (see 8.3)
B.7 Shield ventilation (see 8.4) <\/td>\n<\/tr>\n
65<\/td>\nB.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) <\/td>\n<\/tr>\n
66<\/td>\nB.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 <\/td>\n<\/tr>\n
67<\/td>\nB.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 <\/td>\n<\/tr>\n
68<\/td>\nB.20.5 Common migration rules
B.21 Migration of certain elements (see 10.3) <\/td>\n<\/tr>\n
70<\/td>\nB.22 N-Nitrosamines and N-Nitrosatable substances release (see 10.4)
B.23 Mercaptobenzothiazole (MBT) release (see 10.5) <\/td>\n<\/tr>\n
71<\/td>\nB.24 Antioxidant release (see 10.5) <\/td>\n<\/tr>\n
72<\/td>\nB.25 Formaldehyde release (see 10.5) <\/td>\n<\/tr>\n
73<\/td>\nB.26 Bisphenol A release (see 10.6)
B.27 Colourants (see 10.7)
B.28 Volatile compounds content (see 10.8) <\/td>\n<\/tr>\n
74<\/td>\nB.29 Teat protectors (see 11)
B.30 \ufeff#Cr VI Limit (see 10.3 new) <\/td>\n<\/tr>\n
75<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
76<\/td>\nC.5 Specialised applications
C.6 Medical devices <\/td>\n<\/tr>\n
77<\/td>\nAnnex D (informative)Some examples of suitable fixing devices <\/td>\n<\/tr>\n
80<\/td>\nAnnex E (informative)Soothers \u2014 Assessment of compliance with standard \u2014 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 <\/td>\n<\/tr>\n
81<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
82<\/td>\nF.4 Detection
F.5 Retention Times <\/td>\n<\/tr>\n
83<\/td>\nF.6 Preparation of standard solutions of MBT and antioxidants <\/td>\n<\/tr>\n
85<\/td>\nAnnex G (informative)Graphical representation for determining puncture resistance of a teat <\/td>\n<\/tr>\n
86<\/td>\nAnnex H (informative)A\u2013deviations <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Child use and care articles. Soothers for babies and young children. Safety requirements and test methods<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2019<\/td>\n90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":341698,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-341692","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/341692","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/341698"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=341692"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=341692"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=341692"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}