GB 28482-2012Safety requirements of soothers for babies and young children (English PDF)

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.

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.

6.1 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.

7.1 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.

8.1 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).

9.1 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. […]

9.6 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. […]