3.1 BIOFIBRE® CE 0373/TGA
Medicap® devices are designed, produced, packed and sterilised in conformity with ISO 13485 norm and comply with the essential requirements of European Directive 93/42/EEC regarding medical devices.
In compliance with ISO 10993 norms all pre-clinical tests were performed. Thanks to its chemical, physical and mechanical properties Biofibre® shows the following features:
- biocompatibility
- scarce tissue trauma
- absence of capillarity and bacterial adhesion
- resistance to implant environment
- high flexibility, elasticity and resistance to traction
3.1.1 - AESTETIC FEATURES of BIOFIBRE®
3.1.2 - ANCHORAGE of BIOFIBRE®
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