[Evaluation of the biocompatibility of medical devices based on European standards].

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 of 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.

journal_name

Minerva Med

journal_title

Minerva medica

authors

Pizzoferrato A,Arciola CR,Cenni E,Ciapetti G,Granchi D,Savarino L,Stea S

subject

Has Abstract

pub_date

1995-10-01 00:00:00

pages

423-37

issue

10

eissn

0026-4806

issn

1827-1669

journal_volume

86

pub_type

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