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GB 28482-2012 English PDF (GB28482-2012)

GB 28482-2012 English PDF (GB28482-2012)

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GB 28482-2012: Safety requirements of soothers for babies and young children

This standard specifies the terms and definitions, safety requirements, test methods, packaging methods and product information of soothers for babies and young children. This standard applies to the products that resemble OR function as a soother for babies and young children unless they are being marketed as medical devices.
GB 28482-2012
GB
NATIONAL STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 97.200.50
Y 57
Safety requirements of soothers
for babies and young children
ISSUED ON. JUNE 29, 2012
IMPLEMENTED ON. MAY 01, 2013
Issued by. General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Description of a soother ... 7
5 General safety requirements and test methods ... 10
5.1 Materials ... 10
5.2 Construction ... 11
6 Mechanical performance requirements ... 20
6.1 Impact resistance ... 20
6.2 Puncture resistance ... 20
6.3 Tear resistance ... 20
6.4 Knob, plug and/or cover retention ... 20
6.5 Biting endurance ... 20
6.6 Rotation endurance ... 21
6.7 Integrity ... 21
7 Mechanical performance test method ... 21
7.1 Preparation of samples and general testing methods for oven treatment ... 21 7.2 Test methods ... 22
7.3 Test flow ... 30
8 Chemical performance requirements ... 32
8.1 General requirements ... 32
8.2 Chemical properties ... 32
8.3 Material requirements ... 32
8.4 Migration of certain elements ... 32
8.5 Phthalate content ... 33
8.6 N-nitrosamines and N-nitrosatable substances release ... 33
8.7 2-Mercaptobenzothiazole (MBT) release ... 34
8.8 Antioxidants release ... 34
8.9 Volatile compounds content ... 34
9 Chemical performance test methods ... 34
9.1 Sample preparation ... 34
9.2 Determination of the migration of certain elements ... 35
9.3 Determination of phthalate content ... 37
9.4 Determination of N-nitrosamines and N-nitrosatable substances release ... 37 9.5 Determination of 2-Mercaptobenzothiazole (MBT) and antioxidants release ... 37 9.6 Determination of volatile compounds content ... 39
10 Consumer packaging ... 40
11 Product information ... 40
11.1 General requirements ... 40
11.2 Sale packaging information ... 40
11.3 Instructions for use ... 41
Appendix A (Informative) Information for medical devices ... 43
Appendix B (Informative) Some examples of suitable fixing devices ... 45 Appendix C (Informative) Standard compliance assessment of soother -
Sampling plan and compliance level of newly manufactured samples ... 48 Appendix D (Informative) Methods for the determination of N-nitrosamines and N-nitrosatable substances release in soother ... 50
Appendix E (Informative) Determination of 2-mercaptobenzothiazole (MBT) and/or antioxidants ... 61
Foreword
The technical content of this standard is mandatory.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009 ?€?Directives for standardization - Part 1. Structure and drafting of standards?€?. This standard modifies and adopts the EN 1400-1.2002 ?€?Child use and care articles - Soothers for babies and young children - Part 1. General safety requirements and product information?€?, EN 1400-2.2002 ?€?Child use and care articles - Soothers for babies and young children - Part 2. Mechanical
requirements and tests?€? and EN1400-3.2002 ?€?Child use and care articles - Soothers for babies and young children - Part 3. Chemical requirements and tests?€?, AND the main differences between this standard and EN 1400 series standards are as follows.
- ADD the phthalate content requirements and test methods;
- ADD the informative appendix ?€?Method for determining the amount of
N-nitrosamines and N-nitrosamines deliverables in soothers?€?. Please note that some of the contents of this document may be related to patents. The issuer of this document does not assume responsibility for the
identification of these patents.
This standard was proposed by the China Light Industry Federation.
This standard shall be under the jurisdiction of the National Toy
Standardization Technical Committee (SAC/TC 253).
The drafting organizations of the standard. Guangdong Entry-Exit Inspection and Quarantine Bureau Inspection & Quarantine Technology Center Toy
Laboratory, Good boy Products Co., Ltd., Beijing Certification Center of Light Industry Council, Guangzhou Weikai Detection Technology Research Institute, Shenzhen Entry-Exit Inspection and Quarantine Bureau Toy Testing
Technology Center, Guangdong Entry-Exit Inspection and Quarantine Bureau East Guangdong Toy Testing Center.
The main drafters of this standard. Liu Yongjian, Li Shili, Lei Zaiming, Zhang Yanfen, Yi Lezhou, Wang Mei, Xu Xiaoguang, Wang Xinyu.
Safety requirements of soothers
for babies and young children
1 Scope
This standard specifies the terms and definitions, safety requirements, test methods, packaging methods and product information of soothers for babies and young children.
This standard applies to the products that resemble OR function as a soother for babies and young children unless they are being marketed as medical devices.
This 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 the informative Appendix A. This standard does not apply to feeding teats.
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this Standard.
GB/T 131 Geometrical product specification (GPS) - Indication of surface texture in technical product documentation
GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1.
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 thermoplastics - Accelerated ageing and heat resistance test
GB/T 6682 Water for analytical laboratory use - Specification and test
methods
GB/T 22048 Toys and children products - Determination of phthalate
plasticizers in polyvinyl chloride plastic
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Soother
Article intended for satisfying the non-nutritive sucking need of children. Note. Soother is also known as pacifiers or babies?€? dummies.
3.2
Teat ...

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