title: The biological evaluation of medical devices used in dentistry. The influence of the European Union on the preclinical screening of dental materials.
abstract: The advent of the European Union requires the biological evaluation of all medical devices used in dentistry prior to their general availability for clinical use. Biological evaluation is one component of the 'Essential Requirements' with which all devices need to conform. Such conformity will result in the issue of the CE mark. To facilitate this process, harmonised European standards are required. It is the policy of The European Committee for Standardisation (CEN) that, whenever possible, the relevant International standards will be adopted as European standards.
authors.affiliation: Department of Oral Pathology, University of Birmingham, School of Dentistry, St. Chad's Queensway, UK.
authors.forename: G
authors.initials: G
authors.lastname: Schmalz
authors.forename: R M
authors.initials: RM
authors.lastname: Browne
mesh_terms: D000818:Animals; D003748:Dental Equipment / Q000592:standards*; D003764:Dental Materials / Q000592:standards*; D004353:Drug Evaluation, Preclinical; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D007391:International Cooperation; D011050:Policy Making; D012015:Reference Standards
chemical_list: D003764:Dental Materials