GB 28482-2012 PDF English
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Safety requirements of soothers for babies and young children
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GB 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/GB28482-2012
GB
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 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
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
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 soother
The 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 methods
5.1 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 requirements
6.1 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 method
7.1 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 requirements
8.1 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 methods
9.1 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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