Product requirements concerning medical radiation devices
Directive 93/42/EEC on medical devices has been implemented in Finland with the Act on medical devices and accessories (1505/1994). Harmonised European standards concerning medical radiation devices are prepared by the European Committee for Electrotechnical Standardization (CENELEC). Their catalogue is published in the official journal of the EC. Compliancy of radiation devices is judged by a competent review and evaluation body, a so-called notified body.
