Abstract:
In this study, the standards and standardizing organizations of biomedical devices which are very important in healthcare are investigated. The regulations of biomedical devices in U.S.A, Canada and Europe countries are described briefly. In Turkey, T.S.E (Turkish Standards Institute) which is the only organization in standardization is described. The topics for Health Preparatory Group in 1985-1986 of T.S.E and the relevant standards until 1984 are investigated. The biomedical devices and the hospital equipment manufacturers are investigated. T.S.E Standards related to medical devices are given in tables. Finally, testing procedure on medical devices produced in Turkey and for imported ones are recommended.
