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The packaging is different according to the kind of device.
Fixtures, healing screws, and surgical screws are gamma-ray sterilized packed and BTLock guarantees their sterility for a period of five years.
Remaining components (prosthetic and instrumentation) are packed decontaminated and require an autoclave sterilization before using (see the information sheet).
BTLock packaging conforms to the UE Directive 93/42/ECC for medical devices.
Fixtures, healing screws, and surgical screws’ packaging are characterized by a double package:
- One external in PETG, thermo-sealed by a double layer of aluminium and tyvek
- One internal in crystal PST with cap in ryblene
Implants are packed complete with a mounting tool (no-touch delivery carrier), assembling screw, and surgical screw. Implant packaging has a double label to record the implant data on the patient sheet.
The other products have a single packaging in PVC, thermo sealed by a single layer of tyvek.
Periodically BTLock verifies the validity of its sterilization process in external laboratories both before and after the gamma-ray irradiation, which guarantees the sterility for five years (bioburden tests five years after the packaging are negative).
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