VALUTAZIONE DELLA BIOCOMPATIBILITA DEI DISPOSITIVI MEDICI SECONDO NORME ARMONIZZATE

Translated title of the contribution: Evaluation of biocompatibility testing of medical devices according European standards

A. Pizzoferrato, C. R. Arciola, E. Cenni, G. Ciapetti, D. Granchi, L. Savarino, S. Stea

Research output: Contribution to journalArticlepeer-review

Abstract

Several issues concerning the biocompatibility testing of medical devices as stated in European directive 90/385 and 93/42 are discussed. The authors describe the fundamental characteristics that biomaterials should have to be employed in the human body, the assays useful for testing different aspects to biocompatibility and the harmonized regulations already available or under development. The testing protocol applied by the a. in their Lab covering many issues of biocompatibility is presented: a body of experience was gained over the years and it has been revised under the new regulatory items. In conclusion, the biocompatibility of devices must be assessed following the European harmonized standards, the available. Where proper standards are still lacking, feasible testing methods, even if not officially adopted yet, have to be used.

Translated title of the contributionEvaluation of biocompatibility testing of medical devices according European standards
Original languageItalian
Pages (from-to)423-437
Number of pages15
JournalMinerva Medica
Volume86
Issue number10
Publication statusPublished - 1995

ASJC Scopus subject areas

  • Medicine(all)

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