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Silmedic®
products are manufactured from peroxide-cured silicone under good
manufacturing practices. These products are selected for quality
of the intrinsic property of materials and the purity of formulations.
Silmedic® is available in a variety of mechanical characteristics
and durometers. All SilMedic® silicone products are in strict
compliance with the regulations of European Pharmacopea, USP Class
VI and FDA criteria.
Biocompatibility
Thanks to the quality of surfaces obtained and the
purity of the material SilMedic® products ensure excellent biocompatibility
with the recipient's body tissues, with no biological reaction mechanisms:
- low thrombogenicity
- no tissue adhesions
- very low bacterial adhesion
Hemocompatibility SilMedic® medical grade silicones are among the
most hemocompatible synthetic materials available.
- Platelet trapping is considerably reduced
- Excellent behavior with respect to hemostasis
- Low leucocytosis
- Imperceptable activation of the C3A fraction of complement
- Contact hemolysis is reduced to a minimum
The various features make Silmedic® medical grade
suitable for use in the case of prolonged contact with the blood
(i.e. extracorporeal circulation, catheterization, dialysis, transfusion,
etc...)
Sterilization One of the key properties of Silmedic® is the
physio-chemical resistance of the material to different sterilization
processes. Studies have shown that the mechanical or physical properties
remain virtually unaltered, irrespective of the method of sterilization
(autoclave, dry heat, gamma or ethylene oxide). In the case of or
ethylene oxide sterilization, Silmedic® products ensure very
rapid absorption and desorption without significant bond formation. |