[European regulations concerning medical devices].
The employment in clinical practice and prosthetic surgery of a number of medical devices implies a great responsibility to the operators so as to make the knowledge of existing regulations mandatory. The authors illustrate the problems concerning the free circulation of medical devices within the European market. They describe the new strategy of EEC which led to the definition of the directives which apply to all medical devices and of the harmonized standards for inspecting their biological effects. The appointment of certification bodies and the accreditation of Testing Laboratories are described. Finally, particular attention is given to product certification, which is compulsory for the pre-market approval of medical devices.
Savarino
L
L
Laboratorio di Biocompatibilità, Istituti Ortopedici Rizzoli, Bologna.
Ciapetti
G
G
Granchi
D
D
Pizzoferrato
A
A
D000068:Accreditation; D004869:Equipment Safety; D005060:Europe; D006801:Humans; D007753:Laboratories; D007883:Legislation, Medical; D019736:Prostheses and Implants / Q000592:standards*; D013525:Surgical Instruments / Q000592:standards*
Normativa europea relativa ai dispositivi medici.