IEC/EN standards relating to diagnostic radiology equipment, and testing according to these standards
The paper gives an outlook of history, present and future of international (IEC) and European (EN) standards relating to diagnostic radiology equipment. These standards may be safety, quality assurance or performance standards; all of them include testing methods. Elaboration and publication of a new series of safety standards is in progress.Acceptance and conformance testing activity of the accredited Radiohygiene Department Laboratory of NRIRR according to these standards is reported.
- Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices, O.J. L 169, 1993, 1-51.
- Council Directive 97/43/Euratom of 30 June 1997 on Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposure, and repealing Directive 84/466/Euratom, O.J. L 180, 1997, 22-27.