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Maximum safety

• "Tissue Bank" authorization (authorization n° BT/11/R/008) granted in January 2001 and renewed in 2012: mandatory for procurement activities, storage, distribution and transfer of tissues used for therapeutic purposes.

• Compliance with all the European directives on Human Tissues.

• Clinical selection is performed of living donor patients ONLY by orthopedic surgeons following the instructions set by the Biomedicine Agency (formerly Etablissement Français des Greffes)

• Graft collection is done according to strictest clinical and biological criteria, in compliance with aseptic and sanitary safety rules.

• Biological screening performed under the supervision of an independent and certified biology laboratory. Routine screening look for infection with HIV 1 & 2, HTLV, hepatitis B and C, syphilis.

• Resistant viruses inactivation process, approved by the Institut Pasteur Texcell.

• Inactivation of prions, according to the circular in force since 2001.

• Radiosterilization the PHOENIX grafts according to ISO 11137 standard (formerly EN552 ).

• Traceability control from donation to grafting surgery: computer input in the database of TBF implantation forms sent back by practitioners.

• PHOENIX grafts biocompatibility and safety demonstrated and validated by recognized scientific organizations: Biomatech, CNRS, Institut Pasteur Texcell, LSEH, LMSo.

 

PHOENIX Process 20 Yrs

Dental range

Indications dentaires