[Reduction and replacement of animal tests required in standards for safety testing]

Animal tests which have to be performed according to national (DIN) and international standards (EN and ISO) are evaluated according to the 3Rs principle of Russel and Burch in order to reduce suffering and numbers of test animals and also to completely replace them by non-animal methods. When on January 1, 1995, the EU Medical Devices Directive 93/42/EEC was accepted by all EU member states, animal tests that were essential parts of DIN, EN and ISO standards got a new legal status since for biocompatibility testing EU Directive 93/42/EEC is refering to these standards. In the present study all DIN standards were collected, in which animal testing is required, and they were then evaluated from the view points of both scientific state of the art and of consumer protection to decide if these animal tests can be replaced by non-animal methods. Our search of the literature revealed not only that to each of the animal tests promising alternatives have been proposed but also that only a few of them have sufficiently been validated to date. Moreover, we found that several of the animal tests described in DIN standards are not any more representing the current state of the art in the biomedical sciences. Therefore, these animal tests should immediately be deleted from the standards. Thus we are proposing to the DIN institue, the national agency for standards in Germany, immediate action which is required to update each of these DIN standards according to EU Directive 86/609/EEC for the protection of experimental animals. Our proposals are recommending to completely delete some of the animal tests from the standards, or to replace them by validated alternatives or to conduct formal validation studies with the most promising alternatives.