wetzoeker

A Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Chemical tests

(a) A total test as described below requires 1250 cm2 plastics (total surface area, both sides, of a plastics sample in sheet form with surface area of 625 cm2). The sample - without any printing or label on it - should be cut into pieces of not more than 10 cm2.

For tubing the length (L) in cm is calculated as follows:

D1 = inner diameter in cm

D2 = outer diameter in cm

The tubing should be cut lengthwise into sections measuring approximately 10 cm. For the extraction 10 ml of water is used per surface area of 50 cm2.

(b) The pieces of plastics film or tubing should be placed in a container of borosilicate glass with 250 ml pyrogen-free distilled water obtained from an efficient still having glass condensation surfaces and collecting tubes.

1. If the plastics have been in contact with an anticoagulant solution, the pieces should first be placed in a similar container with cold distilled water (100 ml) and shaken several times. This should be repeated once.

The opening of the container is covered with an inverted beaker and the container is then heated in saturated steam at 110° C for 30 minutes (autoclaving) and then quickly cooled to room temperature and the volume adjusted to 250 ml with pyrogen-free distilled water. It is of no significance if the plastics specimens tend to stick together slightly.

Heat-sensitive plastics material, instead of being heated in an autoclave, may be heated at 70° C for 72 hours.

A blank preparation is made in a corresponding manner omitting the plastics.

Regeling
Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd
Soort
Verdrag
Geldend vanaf
19-04-1982
BWB-id
BWBV0002901
Versie
1982-04-19_0

In de hele regeling · Officiële tekst op wetten.overheid.nl