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 Medjournal_title
Minerva medicaauthors
Pizzoferrato A,Arciola CR,Cenni E,Ciapetti G,Granchi D,Savarino L,Stea Ssubject
Has Abstractpub_date
1995-10-01 00:00:00pages
423-37issue
10eissn
0026-4806issn
1827-1669journal_volume
86pub_type
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