Preclinical safety testing of plastic products intended for use in man.

Plastic material is used for medical devices including biomaterial for numerous applications in man. These applications range from disposable plastic syringes to hip prostheses. In order to assume safety and to comply with legal requirements, preclinical tests are necessary. The plastic material employed should in most cases be tested or evaluated at three levels: (1) toxicity tests with the various ingredients used to manufacture the basic plastic, (2) toxicity tests with the final plastic and (3) toxicity tests with the final device. However, individual testing protocols are required due to the different toxicological profiles of the plastics and the heterogenicity of their application-sites in man. This paper evaluates the studies which may be needed to fulfill these requirements.