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
Public Enquiry End Date
09-Jan-2014
Current Stage
98 - Abandoned project (Adopted Project)
Start Date
27-Mar-2017
Due Date
01-Apr-2017
Completion Date
27-Mar-2017
Directive
Harmonized Standard2001/95/EC - General product safety

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SIST EN 1400:2013/kFprA1:2013

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Relations

Effective Date
01-Jul-2014
Effective Date
01-Dec-2013

Overview

SIST EN 1400:2013/kFprA1:2013 is the European standard establishing safety requirements and test methods for soothers (pacifiers) used by babies and young children. This standard, developed by SIST and prepared by Technical Committee CEN/TC 252, covers products designed to resemble or function as soothers, excluding those meant for clinical medical use or for premature babies. It ensures that soothers are manufactured, tested, and packaged to maximize safety for infant users, focusing on the materials, construction, performance, packaging, and product information.

Key Topics

  • Scope and Applicability
    • Covers soothers for babies and young children, including those with additional functions if they resemble or serve as soothers.
    • Excludes specialty soothers for medical use and feeding teats, which are addressed by other standards.
  • Safety Requirements
    • Specifies detailed criteria for the materials and construction of soothers to prevent choking, ingestion, or injury.
    • Ensures products are free from harmful substances and designed to minimize risk during use.
  • Test Methods
    • Includes rigorous testing for mechanical strength, bite endurance, tensile strength, and durability.
    • Mandates batch testing procedures to verify compliance.
    • Emphasizes that each elastomeric component is tested independently to strict bite endurance and tensile strength standards.
  • Product Information
    • Requires clear labeling and safe packaging to promote proper usage and minimize misuse.

Applications

The practical application of SIST EN 1400:2013/kFprA1:2013 is essential for:

  • Manufacturers: Ensuring that soothers brought to market meet strict European safety requirements, reducing recalls and liability.
  • Retailers and Importers: Demonstrating product compliance within the European Single Market, facilitating easier distribution within member states.
  • Testing Laboratories: Offering harmonized testing procedures for soothers, enabling consistent product evaluation and certification.
  • Regulatory Bodies: Forming the legal basis for market surveillance and consumer protection initiatives.
  • Consumers and Childcare Providers: Assuring parents and caregivers that products have been independently verified for safety and performance.

Soothers that comply with this standard help prevent accidents and ensure the safety and wellbeing of infants and young children during use.

Related Standards

  • EN 14350: Safety requirements and test methods for feeding teats and drinking accessories, not covered by EN 1400.
  • ISO 8124: International standards for child safety in toys and child care articles.
  • Other SIST Standards: Cover additional child use and care articles, ensuring a comprehensive approach to children’s product safety.

Note: Soothers outside the scope of SIST EN 1400:2013/kFprA1:2013 are still recommended to align with applicable requirements where feasible.


By adhering to SIST EN 1400:2013/kFprA1:2013, manufacturers and distributors of soothers for babies and young children demonstrate a commitment to product safety, compliance, and consumer confidence. This standard is a vital reference for anyone involved in the design, production, import, or retail of infant care products within Europe.

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SIST EN 1400:2013/kFprA1:2013

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Frequently Asked Questions

SIST EN 1400:2013/kFprA1:2013 is a draft published by the Slovenian Institute for Standardization (SIST). 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

SIST EN 1400:2013/kFprA1:2013 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.

SIST EN 1400:2013/kFprA1:2013 has the following relationships with other standards: It is inter standard links to SIST EN 1400:2013+A1:2014, SIST EN 1400:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

SIST EN 1400:2013/kFprA1:2013 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.

SIST EN 1400:2013/kFprA1:2013 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
,]GHONL]DRWURNH'XGH]DGRMHQþNHLQPODMãHRWURNH9DUQRVWQH]DKWHYHLQ
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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