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GB 28482-2012: Safety requirements of soothers for babies and young children Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsGB 28482-2012: Safety requirements of soothers for babies and young children---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB28482-2012GB NATIONAL STANDARD 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. Table of ContentsForeword... 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... 611 ScopeThis 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 referencesThe 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 plastic3 Terms and definitionsThe 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 Flexible nipple which is the part of the soother designed to be placed in the mouth. 3.3 Shield Structure positioned at the rear of the teat to reduce the likelihood of the soother being drawn entirely into the child’s mouth. 3.4 Ring or knob Structure positioned adjacent to OR on the shield to facilitate handling of the soother. Note. The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached to the shield or plug. 3.5 Plug Device located within the neck of the teat that secures the teat to the shield. 3.6 Cover Device that prevents open access to the plug.4 Description of a sootherThe structure of soother for infant and young children may contain teat, shield, ring, plug, cover, and knob, etc., as shown in Figure 1 to Figure 4.5 General safety requirements and test methods5.1 Materials For manufacturing of the different soother parts, only such materials shall be used which comply with the requirements set forth in this standard. 5.2 Construction 5.2.1 General requirements The soother shall be free from any sharp projecting points or edges. The surface of the sucking part shall be smooth. The soother shall have no removable parts. 5.2.2 Teat The effective penetration of the teat shall be a maximum of 35 mm. It shall be checked using for example the test penetration gauge as shown in Figure 5. 5.2.3 Shield 5.2.3.1 General requirements The soother shall incorporate a shield. The shield shall be tested as described in 5.2.3.2 AND shall not pull through the template with the shield in any orientation, about the major axis of the soother, relative to the template. 5.2.3.2 Shield test USE a PTFE template, the shape and dimensions of which are as given in Figure 11 and which is supported such that it remains firm and horizontal throughout the test. 5.2.5 Knob, plug and/or cover 5.2.5.1 General requirements A plug shall not project more than 3 mm beyond the sucking face of the shield (SEE Figure 15). 5.2.5.2 Flexible knobs, plugs and/or covers If made of flexible material, the effective penetration of the knob, plug and/or cover shall not be less than 10 mm and not more than 35 mm. 5.2.6 Openings (finger traps) To avoid the entrapment of fingers in any part of a soother, the width of any opening shall not allow the penetration of a 5.5 mm diameter rod, unless the depth of penetration is less than 10 mm, the opening allows the unhindered passage of a 14 mm diameter rod.6 Mechanical performance requirements6.1 Impact resistance The soother shall be tested as described in 7.2.1, AND no part shall break, tear or separate during this test or the tensile strength test as described in 7.2.7.1. 6.2 Puncture resistance The soother shall be tested in accordance with 7.2.2. 6.3 Tear resistance The soother shall be tested as described in 7.2.3. When tested for tear resistance as described in 7.2.3.1, the teat shall not break or separate during the tensile strength test. 6.4 Knob, plug and/or cover retention The soother shall be tested as described in 7.2.4, AND no part shall break or separate to become an accessible part. 6.5 Biting endurance The teat and soft flexible knobs of the soother shall be tested as described in 7.2.5.AND no part shall break, tear or separate during this test or tensile strength test as described in 7.2.7.1. 6.6 Rotation endurance Soother incorporating any part capable of being rotated (360°) within the teat of the soother when a torque of (1 ± 0.2) N • m is applied, shall be tested as described in 7.2.6 AND the teat shall not tear or separate during this test or tensile strength test as described in 7.2.7.1. 6.7 Integrity Additional tests shall be carried out to ensure the integrity of all components not already examined as part of 7.2.1 to 7.2.6.7 Mechanical performance test method7.1 Preparation of samples and general testing methods for oven treatment 7.1.1 Only samples taken directly from the manufacturer prior to being placed on the market shall be artificially aged for 7 days in an aerated drying cabinet at a temperature of 70 °C ± 2 °C (as described in GB/T 3512) AND conditioned as described in 7.1.3. 7.2 Test methods 7.2.1 Impact resistance test PLACE the soother to be tested unsupported on a flat, horizontal steel surface. DROP a flat metal weight with a mass of 1 kg ± 0.2 kg, distributed over an area of diameter 80 mm ± 2 mm, 7.2.2 Puncture resistance test 7.2.2.1 Puncture resistance test of teat CUT the teat from the complete soother as close as possible to the shield and PLACE the teat on a cutting board at least 10 mm thick and (70 ± 5) Shore D hardness (SEE Figure 17). 7.2.3 Tear resistance test 7.2.3.1 Tear resistance test of teat 7.2.5 Biting endurance test 7.2.6 Rotation endurance test This test is applicable to soothers, where any part can rotate inside the teat in accordance with 6.6. CLAMP the shield securely and ROTATE the knob, plug, cover or ring at a 7.2.7 Integrity test 7.2.7.1 General instructions for all tensile tests CLAMP the teat 12 mm ± 2 mm from the shield. Rings shall be held by a clamp, rod or by a hook. Two rods or hooks may be used if the shape of the ring prevents it from being held securely in the required position. Each rod or hook shall have a diameter of 5 mm AND have a circular cross section. 7.3 Test flow The mechanical performance test flow of the soother is as shown in Figure 23.8 Chemical performance requirements8.1 General requirements Materials used in the manufacture of soothers shall be subjected to the sample preparation as specified in 9.1 AND the tests as listed in Table 1. 8.2 Chemical properties The following mentioned vulcanizing agents (such as MBT) and antioxidants do not represent a definitive list. Chemicals other than those mentioned in this standard can be used where toxicological evidence, either on the original chemical or any reaction product, is available to demonstrate that no unacceptable risk is posed when they are used in soothers and an appropriate analytical test procedure for determining migration levels exists. 8.3 Material requirements The materials used in the manufacturer of components of soothers shall be subjected to the tests marked with an “x” in Table 1. 8.4 Migration of certain elements When tested in accordance with 9.2, the migration of elements from all materials used in the manufacture of soothers shall not exceed the limits given in Table 2. 8.5 Phthalate content When tested in accordance with 9.3, the total content of the six phthalates in each material used to manufacture the soother shall not exceed 0.1% (m/m). The 6 phthalates are as shown in Table 3. 8.9 Volatile compounds content When the silicon rubber components of soothers are tested in accordance with 9.6, the volatile compounds content shall not exceed 0.5% (m/m).9 Chemical performance test methods9.1 Sample preparation The sample preparation applies to all tests except for 9.3 and 9.4. 9.1.1 All samples shall be immersed in boiling water (complying with GB/T 6682, grade 3) for 10 min without touching the walls of the container before conditioning. 9.1.2 All samples must be conditioned before testing. The conditioning of the samples shall be performed, for at least 40 h, in a standard atmosphere at a temperature of 23 °C ± 2 °C and relative humidity of (50 ± 5) %. Samples shall remain in the conditioning atmosphere until the tests are carried out. The tests can be carried out in a non-conditioned room. 9.2 Determination of the migration of certain elements 9.2.1 Principle Soluble elements (antimony, arsenic, barium, cadmium, chrome, lead, mercury and selenium) are extracted from the individual components of the soother which are accessible to the child. Conditions which simulate contact with stomach acid shall be used. The concentrations of the soluble elements are described quantitatively. 9.2.2 Apparatus 9.3 Determination of phthalate content The phthalates content in the soother are determined in accordance with GB/T 22048. 9.4 Determination of N-nitrosamines and N-nitrosatable substances release The release of N-nitrosamines and N-nitrosatable substances in the soother shall be determined in accordance with Appendix D. 9.5 Determination of 2-Mercaptobenzothiazole (MBT) and antioxidants release 9.6 Determination of volatile compounds content CUT appropriately 10 g of sample into pieces of approximately 2 cm2.STORE the sample for 48 h in a desiccator at room temperature. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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