ISO 29941-2010 pdf free download

ISO 29941-2010 pdf free download.Condoms Determination of nitrosamines migrating from natural rubber latex condoms
Préservatifs — Dosage des nitrosamines migrant des préseivatifs en latex de caoutchouc naturel.
7.2.3 Procedure B
7.2.3.1 Close the measuring cylinder with the solution (7.2.1), shake it until it is homogeneous; slowly pour the solution into the separating funnel (6.10).
7.2.3.2 Add at least 20 ml of dichioromethane and shake it well for at least 1 mm. After the phase separation and possible centrifuging to destroy any existing emulsion, transfer the lower phase over 30 g of pre-washed sodium sulfate or another suitable phase separating filter (5.11) to the Kudema-Danish collecting vessel or an equivalent apparatus (6.5).
7.2.3.3 Repeat the procedure described under 7232 twice
7.2.3.4 Wash the sodium sulfate (or the suitable phase separation filter) (5.11) with 25 ml of dichloromethane (5.1) and transfer the washing solution also to the Kudema-Danish collecting vessel or the equivalent apparatus (6.5).
7.3 Concentration of the N-nitrosamines in the solution
7.3.1 Add 2 ml of n-hexane (5.3) and two or three boiling chips (5.6) to the extract in the Kuderna-Danish collecting vessel (or in the equivalent apparatus) (6.5). which was made according to procedure A or B.
Put the air cooler onto the apparatus. Concentrate the solution in the water bath (6.6) to a volume of 4 ml to 6 ml. To avoid losses of testing substance, slowly warm the water bath from (40 ± 2) C at a rate of approximately 2 °C/min to (60 t 2) °C. After the solution has cooled down, rinse the walls of the vaporizer and concentration system with (2 ± 0.1) ml of dictdoromethane (5.1).
Work shall be performed in a fume hood due to the flammability of the hexane.
7.3.2 Remove the air cooler from the Kudema-Danish collecting vessel (or the equivalent apparatus) and concentrate the solution to (1 ± 0,1) ml by cautiously streaming nitrogen (5.5) over it. Allow the solution to cool down to room temperature and transfer it to a vial that is dosed with septum and vial mouth ring (6.7).
The nitrogen flow shall be adjusted in such a way as to create a depression of 4 mm to 5 mm on the surface of the concentrated eluate, as otherwise the liquid might spill over or the extract might get too cold.
Owing to the volatility of the N-nitrosamines, the volume shall not fall below the minimum volumes mentioned in 7.3.1 and 7.3.2. If the period of time between the concentration of the solution and the measuring of the N-nitrosamines exceeds 1 Ii. store the solution in the dark at a temperature below 5 °C.
7.4 Blank preparation
Run the blank preparation by carrying out all the processes described below, but without condom material and during the migration step (7.1.2).ISO 29941-2010 pdf free download.