BS/EN 12868-2017 pdf download.Child use and care articles Method for determining the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers.
8.2 Sample Preparation
Feeding teats shall be taken as they are from the packaging or detached from containers (usually baby bottles).
Soother teats shall be taken as a whole, including the bead. Therefore they shall be removed from the soother without cutting the teat, which may require destruction of the plastic parts of the soother. Any tool used to remove the teat from the soother shall not contaminate the teat.
Where the soother teat covers part of the shield, the teat Including that part should also be removed without any damage as a whole.
When cutting of the teat is unavoidable, it shall be stated in the test report.
For whole elastomer soothers or soothers having different parts made of elastomers, the elastomer components shall be separated and tested as separate samples.
NOTE Different parts in whole elastomer soothers are for example teat, mouth shield and ring. These parts may have been manufactured by different technology or with different composition.
8.3 Sample A (for determination of N-nitrosatable substances)
8.3.1 Preparation and pre-boiling
For each determination from sample A. the sample weight shall be (5.5 ± 0,5) g (see A.4), using a balance capable of weighing with a precision of at least ± 0.01 g.
Cut the teats in half along the major axis to obtain nearly symmetrical pieces.
Weigh as many halves as necessary to make up a total weight of minimum 5,0 g. If the weight exceeds 6.0 g cut the last half along the major axis in two parts to obtain nearly symmetrical pieces, and remove one piece. If necessary. repeat the same procedure with the smallest piece until reaching the required sample weight.
For feeding teats, each piece may be cut once more through the middle at right angles to the initial cut to ensure complete immersion.
For soother teats, no further cutting shall be undertaken.
Other elastomer parts of a soother shall be tested as separate samples. They shall be cut symmetrically along the major axis and also along the minor axis and if necessary be cut further as described above to match the required sample weight.
Note the weight of the sample(s) as G(s) In g.
For each determination from sample A, transfer the sample pieces to a beaker with (300 ± 30) ml of boiling water (5.1) and boil for 10 mm. Remove them from the water with tweezers or tongs and shake off excess water. Transfer immediately into a flask as given in 8.3.2.
For ready to use products (see 3.9), the boiling step shall be omitted, which shall be noted in the test report.
The above amount of sample represents the necessary minimum. To achieve the necessary limits of detection, larger sample amounts may be used up to a maximum of 10 g. Ratios of sample to migrating solution shall be maintained and the volume of any glassware including separation columns, and the volume of reagents shall be proportionally increased during 8.3 to 8.6. See A.4.
8.3.2 Preparation of Migrate A (for determining N-nitrosatable substances) See A.2
Use a conical flask of a size (approximately 30 ml) suitable to hold the pieces of Sample A.
The sample shall remain completely Immersed in the artificial saliva salt solution.
Place the sample pieces from 8.3.1 into the flask and add, by pipette, the volume of 4 ml per gram of
sample (G(s) x 4 ml / g) of the artificial saliva salt solution (5.5).
For example, if G(s) = 5,7 g, the volume of artificial saliva salt solution shall be (22,8 ± 0.5) ml.
Close with a ground glass stopper and gently shake to ensure the pieces are completely immersed in the solution, and place the closed flask at (40 ± 2) °C for (24 ± 0,5) h in the oven (6.2).
NOTE Complete immersion can be aided by addition of glass beads to the flask.
After that time, remove the flask from the oven and vigorously shake 5 times by hand (see AS).BS/EN 12868-2017 pdf download.