DIN EN ISO 7405:2013-12

This standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. The standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body. As a new test, a dentine barrier cytotoxicity test (cell compatibility test) suitable for testing a has been incorporated in Annex B which is suitable for testing a filling material (for example, adhesives, composites, compomers, cements). Now a laboratory test is described instead of previously required animal testing where various cavities on monkey teeth have been prepared and filled with the material to be tested. Contrary to animal testing (where the quality of the preparator was often tested), the results are better reproducible und the ethical issues linked with animal testing are eliminated. Amendment 1 refers to the reproducible positive control material: For both in vitro and in vivo tests, it is advisable to include a standard positive control material, which is handled and processed like the test materials (that is, being plastic after mixing and then setting) and which is based on freely available chemicals or materials. Such a positive control material for in vitro testing of plastic filling materials is described in Annex B, Table B.1. The use of this specific positive control material is optional and other materials with a validated history and other well characterized positive control materials with reproducible data on toxicity can be used instead. The International Standard has been prepared by ISO/TC 106/WG 10 "Biologische Prüfungen" ("Biological evaluation") (secretariat: DIN), together with CEN/TC 55 "Dentistry" (secretariat: DIN). On the national level, the responsible Committee is Working Committee NA 014-00-20 AA "Biologische und klinische Werkstoffprüfung" ("Biological and clinical material testing") at NADENT.