title: Criteria and suspension levels in diagnostic radiology.
abstract: The EC (European Council) Directive on radiation protection of patients requires that criteria for acceptability of equipment in diagnostic radiology, nuclear medicine and radiotherapy be established throughout the member states. This study reviews the background to this requirement and to its implementation in practice. It notes and considers parallel requirements in the EC medical devices directive and International Electrotechnical Commission standards that it is also important to consider and that both sets of requirements should ideally be harmonised due to the global nature of the equipment industry. The study further reviews the types of criteria that can be well applied for the above purposes, and defines qualitative criteria and suspension levels suitable for application. Both are defined and relationships with other acceptance processes are considered (including acceptance testing at the time of purchase, commissioning and the issue of second-hand equipment). Suspension levels are divided into four types, A, B, C and D, depending on the quality of evidence and consensus they are based on. Exceptional situations involving, for example, new or rapidly evolving technology are also considered. The publication and paper focuses on the role of the holder of the equipment and related staff, particularly the medical physics expert and the practitioner. Advice on how the criteria should be created and implemented is provided for these groups and how this might be coordinated with the supplier. Additional advice on the role of the regulator is provided.
authors.affiliation: Trinity College Centre for Health Sciences, Dublin 8, Ireland. jfmalone@tcd.ie
authors.forename: J
authors.initials: J
authors.lastname: Malone
authors.forename: P
authors.initials: P
authors.lastname: Baldelli
authors.forename: S
authors.initials: S
authors.lastname: Balter
authors.forename: N
authors.initials: N
authors.lastname: Bischof
authors.forename: H
authors.initials: H
authors.lastname: Bosmans
authors.forename: A
authors.initials: A
authors.lastname: Dowling
authors.forename: S
authors.initials: S
authors.lastname: Edyvean
authors.forename: A
authors.initials: A
authors.lastname: Gallagher
authors.forename: K
authors.initials: K
authors.lastname: Faulkner
authors.forename: K
authors.initials: K
authors.lastname: Horner
authors.forename: L
authors.initials: L
authors.lastname: Malone
authors.forename: I D
authors.initials: ID
authors.lastname: Mclean
authors.forename: U
authors.initials: U
authors.lastname: O'Connor
authors.forename: A
authors.initials: A
authors.lastname: Schreiner
authors.forename: J
authors.initials: J
authors.lastname: Vassileva
authors.forename: E
authors.initials: E
authors.lastname: Vano
authors.forename: J
authors.initials: J
authors.lastname: Zoetelief
mesh_terms: D005060:Europe; D006801:Humans; D009683:Nuclear Medicine / Q000379:methods / Q000592:standards*; D011832:Radiation Injuries / Q000517:prevention & control; D011835:Radiation Protection / Q000379:methods; D011871:Radiology / Q000379:methods / Q000592:standards*; D011878:Radiotherapy / Q000379:methods / Q000592:standards*