EN 1400-1:2002

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Description of a soother
5 Requirements and test methods
  5.1 Materials
  5.2 Construction
6 Consumer packaging
7 Product information
  7.1 General
  7.2 Purchase information
  7.3 Instructions for use
Annex A (informative) Information for medical devices
      A.1 Resemble a soother but no other function
      A.2 Resemble a soother but having another minor function
      A.3 Resemble a soother but having another major function
      A.4 Specialised applications
      A.5 Medical devices
Bibliography

This part of this European Standard specifies general safety requirements relating to the materials, construction, packaging and labelling of soothers. It includes also requirements relating to the instructions for use.This European Standard is applicable to products that resemble or function as a soother unless they are being marketed as medical devices. This European Standard does not apply to products designed for specialist medical applications, e. g., those relating to Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex (see Annex A).NOTEIt 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.