EN 1400:2013/FprA1
(Amendment)Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
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).
NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied.
The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats are included in all parts EN 14350.
Modification to Clause 9.5.2, Test method
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Sicherheitstechnische Anforderungen und Prüfverfahren
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Exigences de sécurité et méthodes d'essai
Izdelki za otroke - Dude za dojenčke in mlajše otroke - Varnostne zahteve in preskusne metode - Dopolnilo A1
General Information
- Status
- Not Published
- Technical Committee
- CEN/TC 252 - Child use and care articles
- Drafting Committee
- CEN/TC 252/WG 5 - Feeding, drinking, sucking and similar functions
- Current Stage
- 5060 - Closure of Vote - Formal Approval
- Start Date
- 24-Jan-2014
- Due Date
- 07-Feb-2015
- Completion Date
- 24-Jan-2014
Relations
- Effective Date
- 19-Jan-2023
- Effective Date
- 26-Jun-2013
Overview
EN 1400:2013/FprA1 is the CEN European Standard for soothers (pacifiers) used by babies and young children. It specifies safety requirements and test methods for materials, construction, performance, packaging and product information for products that resemble or function as soothers. The amendment (FprA1) updates specific test-method details (notably the bite endurance test in Clause 9.5.2). The standard excludes specialist clinical medical devices (e.g., for Pierre‑Robin syndrome or premature babies) and feeding teats (covered by EN 14350), but recommends excluded soothers meet applicable requirements where possible.
Key topics and technical requirements
- Scope and applicability
- Applies to consumer soothers and multifunction products that resemble or function as soothers (examples referenced in Annex C).
- Excludes specialist clinical products and feeding teats (EN 14350).
- Materials and construction
- Requirements to minimise choking, toxicological and mechanical risks from elastomeric parts and other components.
- Performance and test methods
- Bite endurance of elastomeric components (Clause 9.5.2 - amended):
- Use new samples (preferably same batch) for each test.
- Specific positioning of teat, ring, knob and shield between bite endurance jaws (see Figure 27).
- Apply a maximum load of (400 ± 10) N and a minimum load of (200 ± 10) N while the upper jaw cycles 50 times at a crosshead speed of (10 ± 1) mm/min.
- After bite endurance treatment, perform tensile strength testing per Clause 9.7.2.2 by applying force at right angles to the major axis.
- Guidance: ensure biting edges remain aligned; guide bars may be used.
- Bite endurance of elastomeric components (Clause 9.5.2 - amended):
- Packaging and product information
- Labelling, instructions for use and packaging requirements to reduce misuse and improve traceability.
Practical applications
- Ensures soothers meet consistent safety and durability levels for everyday consumer use.
- Used to validate product design, quality control and compliance before placing products on the European market.
- Provides test procedures for mechanical ageing and strength verification of elastomeric parts (teat, ring, knob, shield).
Who uses this standard
- Manufacturers and designers of soothers and multi‑function baby products
- Third‑party testing and certification laboratories
- Retailers sourcing compliant child care articles
- Regulatory and conformity assessment bodies in Europe
- Product safety engineers and quality assurance teams
Related standards
- EN 14350 - Safety requirements and test methods for feeding teats (feeding bottles and teats)
- National implementations and translations prepared by CEN members (e.g., SIST EN 1400:2013/kFprA1)
Keywords: EN 1400:2013/FprA1, soothers safety standard, bite endurance test, elastomeric components, CEN standard, soothers test methods.
Frequently Asked Questions
EN 1400:2013/FprA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Child use and care articles - Soothers for babies and young children - Safety requirements and test methods". This standard covers: 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). NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied. The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats are included in all parts EN 14350. Modification to Clause 9.5.2, Test method
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). NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied. The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats are included in all parts EN 14350. Modification to Clause 9.5.2, Test method
EN 1400:2013/FprA1 is classified under the following ICS (International Classification for Standards) categories: 97.190 - Equipment for children. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1400:2013/FprA1 has the following relationships with other standards: It is inter standard links to EN 1400:2013+A1:2014, EN 1400:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1400:2013/FprA1 is associated with the following European legislation: EU Directives/Regulations: 2001/95/EC; Standardization Mandates: M/264. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1400:2013/FprA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2013
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SUHVNXVQHPHWRGH'RSROQLOR$
Child use and care articles - Soothers for babies and young children - Safety
requirements and test methods
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder -
Sicherheitstechnische Anforderungen und Prüfverfahren
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Exigences de
sécurité et méthodes d'essai
Ta slovenski standard je istoveten z: EN 1400:2013/FprA1
ICS:
97.190 Otroška oprema Equipment for children
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
FINAL DRAFT
EN 1400:2013
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
October 2013
ICS 97.190
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 Artikel für Säuglinge und Kleinkinder - Schnuller für
jeunes enfants - Exigences de sécurité et méthodes d'essai Säuglinge und Kleinkinder - Sicherheitstechnische
Anforderungen und Prüfverfahren
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 252.
This draft amendment A1, if approved, will modify the European Standard EN 1400:2013. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1400:2013/FprA1:2013: E
worldwide for CEN national Members.
Contents Page
Foreword .
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