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I — Chemical tests Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Chemical tests

The tests are intended to be applied to plastics blood transfusion equipment. This equipment consists of two main categories:

(1) plastics containers for the collection, separation and storage of blood and blood products;

(2) plastics sets for taking and giving blood.

The tests shall be carried out on the materials after they have been sterilised by the method to be used in the final sterilisation of the equipment. These materials shall include:

1) the plastics used to make the containers,

2) the tubing used in the containers and

3) the blood-taking and giving sets.

The tests on containers shall be carried out before the containers are filled with anticoagulant solution. However, if the tests are carried out on containers which have been filled with anticoagulant solution, the limit tests in Section III on the anticoagulant solution itself shall be taken into account when evaluating the results of the tests on the container.

The manufacturer of the transfusion equipment is required to disclose to the appropriate health authority the detailed formulations of the plastics material or materials and other materials used in the manufacture of the equipment, the source of the components of the material or materials and their methods of manufacture (or alternatively, the compound reference numbers), details of manufacture of the equipment, the nature of any processing additives and adhesives and the method of sterilisation. No change shall be permitted in any of the foregoing without prior submission to and approval of the appropriate health authority.

Each batch of raw material used in the manufacture of the equipment shall be identified by a batch number, which shall be recorded by the manufacturer of the equipment together with the identification numbers of all batches of transfusion equipment made from it and the results of all tests relevant to these batches.

Every practicable precaution must be taken to reduce the risk of adventitious contamination at each stage of the manufacturing process.

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