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Industrial research

The laboratory of Preclinical and Surgical Studies performs research activities for the Public and Privates, Universities and Companies.

Research activities vary according to requirements of customers and range from evaluation of cytotoxicity, mutagenesis and biocompatibility to preclinical studies with preparation of  complex experimental models for the evaluation of therapeutic efficacy of innovative medical and surgical strategies. The activities are conducted in accordance with specific contracts signed by both parties.
Regarding the biocompatibility, the laboratory performs tests for the evaluation of medical devices, and then works in the field of the following standards:

  • Legislative Decree n. 507 (12.14.1992). Implementation of Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices. Ordinary supplement to Official Gazette of the Italian Republic - General Series n.305 of 30/12/1992, and subsequent drafts and changes.
  • Legislative Decree n. 46 (02.24.1997). Implementation of Directive 93/42/EEC concerning medical devices.
  • Ministerial Decree of the Ministry of Health (09/22/2005). National Classification of Medical Devices (CND).

As set out in Directive 93/42/EEC, medical devices must satisfy fundamental requirements including also biocompatibility and considering the final clinical device destination. Therefore, the evaluation of these requirements, as set out in the Directive itself, is carried out satisfying the specific national laws and adopted pursuant to the harmonized standards.
The International standard ISO 10993 - Biological evaluation of medical devices on the biological evaluation of medical devices, including several parts already adopted by the EU as a norm EN 30993, suggests in part 1, concerning the selection of tests to be performed, which of these should be conducted according to the end use of the device and the duration of contact with the body.