1、BSI Standards PublicationBS EN 1400:2013Child use and care articles Soothers for babies and youngchildren Safety requirementsand test methodsBS EN 1400:2013+A1:2014BS EN 1400:2013+A1:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1400:2013+A1:2014. It supe
2、rsedes BS EN 1400:2013 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags.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 i
3、n 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 i
4、nclude 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 9ICS 97.190Compliance with a British Standard cannot confer immunity from legal obligations.This B
5、ritish Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2013.Amendments/corrigenda issued since publicationDate Text affected30 June 2014 Implementation of CEN amendment A1:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1400:2013+A1 Apri
6、l 2014 ICS 97.190 Supersedes EN 1400:2013English Version Child use and care articles - Soothers for babies and young children - Safety requirements and test methods Articles de puriculture - Sucettes pour nourrissons et jeunes enfants - Exigences de scurit et mthodes dessaiArtikel fr Suglinge und Kl
7、einkinder - Schnuller fr Suglinge und Kleinkinder - Sicherheitstechnische Anforderungen und Prfverfahren 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 Regulatio
8、ns 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. T
9、his 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 me
10、mbers 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, Port
11、ugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any f
12、orm and by any means reserved worldwide for CEN national Members. Ref. No. EN 1400:2013+A1:2014 EEN 1400:2013+A1:2014 (E) 2 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 Prin
13、ting 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
14、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 (informativ
15、e) 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) Adeviations . 84 Bib
16、liography . 85 BS EN 1400:2013+A1:2014EN 1400:2013+A1:2014 (E) 2 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
17、 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
18、 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 o
19、f 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) Adeviations . 84 Bibliography . 85 EN 1400:2013+A1:2014 (E) 3 Foreword This doc
20、ument (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 lat
21、est 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
22、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 C
23、EN 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 mo
24、st 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 com
25、mon migration rules have been adopted as has the concept of allocating only a proportion of TDIs 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
26、 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, Icela
27、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1400:2013+A1:2014EN 1400:2013+A1:2014 (E) 4 Introduction Soothers are widely used throughout Europe to satisf
28、y 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 futu
29、re. 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 th
30、e 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 th
31、at 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 organisa
32、tions 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
33、, 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. How
34、ever, 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 ann
35、ex has been included which contains translations of warning phrases into the main European languages. BS EN 1400:2013+A1:2014EN 1400:2013+A1:2014 (E) 4 Introduction Soothers are widely used throughout Europe to satisfy non-nutritive sucking needs and to pacify children. They are designed to be in th
36、e 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
37、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
38、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 man
39、agement 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 fo
40、r 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 be
41、en 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 reconside
42、red 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 E
43、uropean languages. EN 1400:2013+A1:2014 (E) 5 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. So
44、me 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 bab
45、ies (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 indispensabl
46、e 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
47、-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 N-Nitrosamine
48、s and N-Nitrosatable substances from elastomer or rubber teats and soothers EN 20105-A03, Textiles Tests for colour fastness Part A03: Grey scale for assessing staining (ISO 105-A03) EN ISO 1302, Geometrical Product Specifications (GPS) Indication of surface texture in technical product documentatio
49、n (ISO 1302) EN ISO 3696, Water for analytical laboratory use Specification and test methods (ISO 3696) ISO 188, Rubber, vulcanized or thermoplastic Accelerated ageing or heat resistance tests 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
