Technical standards for medical devices. Assisted circulation devices.
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.
Clemente
F
F
Institute of Biomedical Technologies, National Research Council of Italy, Roma. clemente@color.irkant.rm.cnr.it
Ferrari
G F
GF
De Lazzari
C
C
Tosti
G
G
D001243:Assisted Circulation / Q000592:standards*; D019985:Benchmarking; D001698:Biomedical Engineering / Q000379:methods*; D004867:Equipment Design; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards; D017408:Guidelines as Topic; D006353:Heart-Assist Devices / Q000592:standards; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D007558:Italy; D012680:Sensitivity and Specificity