Biological evaluation of dental materials.

Dental materials and devices are being treated more like drugs and now have to meet the safety and efficacy requirements of drugs and medical devices. Biocompatibility is the key word. The history of the development of controls, standards, and guidelines began almost 500 years ago and is detailed in a chronological fashion up to the present time. An outline of the latest revised draft of the international document (ISO Technical Report No. 7405), to be completed hopefully by 1993 in time for the harmonization of the European Standards within the EC, is presented. The types of tests (initial, secondary, and preclinical usage tests) are listed and described. No amount of experimental study can guarantee absolute safety for any substance. However, toxicological investigations provide data from which reasonable projections and predictions can be made about the conditions under which the product can be safely used. It is the intent that this Technical Report be reviewed regularly and revised, with the ultimate objective of converting it to an International Standard.