Abstract
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.
| Original language | Italian |
|---|---|
| Pages (from-to) | 481-493 |
| Number of pages | 13 |
| Journal | Minerva Medica |
| Volume | 86 |
| Issue number | 11 |
| Publication status | Published - 1995 |
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ASJC Scopus subject areas
- Medicine(all)
Cite this
NORMATIVA EUROPEA RELATIVA AI DISPOSITIVI MEDICI. / Savarino, L.; Ciapetti, G.; Granchi, D.; Pizzoferrato, A.
In: Minerva Medica, Vol. 86, No. 11, 1995, p. 481-493.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - NORMATIVA EUROPEA RELATIVA AI DISPOSITIVI MEDICI
AU - Savarino, L.
AU - Ciapetti, G.
AU - Granchi, D.
AU - Pizzoferrato, A.
PY - 1995
Y1 - 1995
N2 - 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.
AB - 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.
KW - accreditation
KW - certification
KW - European standardization
KW - medical devices
UR - http://www.scopus.com/inward/record.url?scp=0029554832&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0029554832&partnerID=8YFLogxK
M3 - Articolo
VL - 86
SP - 481
EP - 493
JO - Minerva Medicolegale e Archivio di Antropologia Criminale
JF - Minerva Medicolegale e Archivio di Antropologia Criminale
SN - 0026-4806
IS - 11
ER -