1 Scope
This standard specifies the terms and definitions, safety requirements, test methods, packaging and product information of soothers for babies and young children.
This standard is applicable to products that assemble or function as soothers for babies and young children unless they are being marketed as medical devices.
This standard does not apply to similar products designed for specialist medical applications, e.g. those relating to Pierre-Robin Syndrome or premature babies. These special cases are described in informative Annex A.
This standard is not applicable to feeding teats.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 131 Geometrical Product Specifications (GPS) - Indication of Surface Texture in Technical Product Documentation
GB/T 2828.1 Sampling Procedures for Inspection by Attributes - Part1 : Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection
GB/T 2918 Plastics - Standard Atmospheres for Conditioning and Testing
GB/T 3512 Rubber, Vulcanized or Thermoplastic - Accelerated Ageing and Heat Resistance Tests - Air-oven Method
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods
GB/T 22048 Toys and Children's Products - Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
soother
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Description of a Soother
5 General Safety Requirements and Test Methods
5.1 Materials
5.2 Construction
6 Mechanical Property Requirements
6.1 Impact Resistance
6.2 Puncture Resistance
6.3 Tear Resistance
6.4 Knob, Plug and/or Cover Retention
6.5 Biting Endurance
6.6 Rotation Endurance
6.7 Integrity
7 Mechanical Property Test Method
7.1 Preparation of Samples and General Test methods for Oven Treatment
7.2 Test Methods
7.3 Test Procedure
8 Chemical Property Requirements
8.1 General
8.2 Chemical Properties
8.3 Requirements by Material
8.4 Migration of Certain Elements
8.5 Content of Phthalate
8.6 N-Nitrosamines and N-Nitrosatable Substance Release
8.7 2-mercaptobenzothiazole (MBT) Release
8.8 Antioxidants Release
8.9 Volatile Compounds Content
9 Chemical Property Test Method
9.1 Sample Preparation
9.2 Determination of the Migration of Certain Elements
9.3 Determination of Phthalate Content
9.4 Determination of N-Nitrosamines and N-Nitrosatable Substance Release
9.5 Determination of 2-mercaptobenzothiazole (MBT) and Antioxidants Release
9.6 Determination of Volatile Compounds Content
10 Consumer Packaging
11 Product Information
11.1 General
11.2 Sales Packaging Information
11.3 Instruction for Use
Annex A (Informative) Information for Medical Devices
Annex B (Informative) Some Examples of Suitable Fixing Devices
Annex C (Informative) Soothers - Assessment of Compliance with Standard - Sampling Plan and Compliance Levels for Freshly Manufactured Samples
Annex D (Informative) Determination of N-Nitrosamines and N-Nitrosatable Substance Release from Soother
Annex E (Informative) Determination of 2-Mercaptobenzothiazole (MBT) and/or Antioxidants
