Testing of polymer materials: What methods should be used?

By Kjellstrand, P. - Boberg, U.

Tests, performed over a ten-year period, on 653 polymers intended for use in extracorporeal renal replacement therapy, were evaluated. The test battery used included animal tests, in vitro tests and chemical tests. Some tests were found to have a very low sensitivity. Thus, acute systemic toxicity testing in mice with sodium chloride, ethanol or paraffin oil as extractants was performed on a total of 806 occasions. Only two of these resulted in a "fall" decision. The final outcome of the tests for the majority of materials could be predicted by the results of the UV absorption, chloride, inhibition of cell growth, and tin tests. Of the materials that passed these four tests, less than 2% were not approved on the basis of the whole test battery. The experiments show that only a limited number of tests have to be performed when testing polymers intended for use in extracorporeal renal replacement therapy.