EN 1400 Child Use and Care Products - Pacifiers for Babies and Young Children - Safety Requirements and Test Methods

The European standard "EN 1400 Products for child use and care - Pacifiers for infants and young children - Safety requirements and test methods" describes the safety requirements for materials, construction, performance, packaging and product information for pacifiers. This standard can be applied to products that resemble or function as pacifiers. Some pacifiers may be marketed with other functions. Some examples of the application of this standard are included in the annex of the standard (Annex C).

However, this standard does not apply to products designed for specialist clinical medical applications, for example products for Pierre-Robin syndrome or premature babies. It also does not apply to feeding teats. Safety requirements and test methods for feeding teats are included in all parts of the EN 14350 standard.

For the purposes of this standard, the following terms and definitions apply:

• Pacifier refers to an article that contains a teat and is intended to meet the non-nutritive sucking need of children.
• The nipple is the part of the pacifier that is designed to be placed in the mouth.
• The shield is the structure placed behind the pacifier to reduce the possibility of the pacifier being pulled completely into the child's mouth.
• The ring is the structure placed adjacent to or on the shield to facilitate grasping the pacifier.
• The button is the structure placed adjacent to or on the shield to facilitate grasping the pacifier.
• The plug is the device located at the neck of the teat that secures the teat to the shield.
• The cap is the device that prevents the plug from having open access.
• The main axis of the teat, the main axis of the teat passes at right angles to the shield and through the middle of the teat, the nipple enters the shield.
• The main axis of the shield is parallel to the longest dimension of the shield and is in the middle of its width.

A teat usually consists of: a teat, a shield, a ring or button, a plug, and a cap. Some or all of the components may be manufactured from the same material, making it difficult to distinguish between the individual components. The ring, button, or cap may be integral with the shield or plug, or may be a separate component attached to the shield or plug.

Equipment used in the tests includes:

• The shield template shall have the following properties: made of polyoxymethylene (POM), standard (natural, unpigmented, unfilled), E-modulus 3000 MPa to 3300 MPa, hardness 80 to 90 Shore D, surface roughness less than Ra 2,2. Extruded POM sheets normally meet the surface roughness requirement. The dimensions shall be as shown in the figure given in the standard.
• Test spheres A, B, C and D shall be made of stainless steel with the diameters given in the table.
• The indenter is made of H13 high chromium tool steel or equivalent and hardened to a minimum of 50 Rockwell C and shall have the dimensions shown in the figure. All dimensions with tolerances are machined to Ra 1302 in EN ISO 0,4. The larger diameter of the indenter is not specified because it must be sized to fit into the equipment to apply the required force specified in the test methods.
• The cutting board must be made of a polymeric material with a Shore D hardness of (70 plus/minus 5) with a stopper made of any suitable material suitable for the dimensions shown in the figure. All dimensions must be within a tolerance.

Babies and toddlers often chew or suck on pacifiers for comfort. The EN 1400 standard guarantees:

• Materials used are non-toxic (safe to keep in mouth)
• No small parts that could become loose and pose a choking hazard
• Shape and design prevents swallowing or entering too deeply into the mouth

When parents see a pacifier labelled as compliant with the EN 1400 standard, they can be sure that:

• Rigorously tested
• Meets minimum health and safety standards
• Designed to reduce risk even in daily use

The EN 1400 standard includes tests and rules for:

• Chemical safety (e.g. does not contain bisphenol A)
• Mechanical safety (e.g. has tensile strength)
• Hygiene requirements (e.g. ease of cleaning and sterilization)
• Instructions and labeling to assist with safe use

Our organization, which has been trying to support businesses from every sector with its testing, measurement, analysis and evaluation studies carried out in a wide range for years, has a strong staff that closely follows the developments in the world in the field of science and technology and constantly improves itself. In this context, testing services in accordance with the "EN 1400 Child use and care products - Pacifiers for babies and young children - Safety requirements and test methods" standard are also provided to businesses.