Affiliations: Institute of Biomedical Technologies, National Research Council of Italy, Via G.B. Morgagni 30/e, 00161 Roma, Italy
Correspondence:
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Correspondence: Fabrizio Clemente, Institute of Biomedical Technologies, Via G.B. Morgagni 30/e, 00161 Roma, Italy. Tel.: +39 6 86894728; Fax: +39 6 86090312; E-mail: clemente@color.irkant.rm.cnr.it.
Abstract: The steep rise in the clinical use of high technology biomedical devices and materials, involving multidisciplinary competencies, points out the problem of mutual standards defining, first of all, functional characteristic and tests able to characterise and qualify devices, materials and minimal safety requirements both for patients and operators. Standards defined by consent of the parties or by law are used to this aim. Fast technical development in specific sectors produces besides lack of rules, which must be quickly filled up. The aim of this paper is both the presentation of the approach to problems related to technical standards for biomedical devices and the presentation of the set up of a technical standard for mechanical heart assist devices.
Keywords: Quality and safety of medical devices, technical standards, heart assist devices, benchmark, European Directives 90/385 and 93/42
