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The packaging is different according to the kind of device.
Fixtures, healing screws, and surgical screws are gamma-ray sterilised
packed and BTLock guarantees their sterility for 5 years.
Remaining components (prosthetic and instrumentation) are packed
decontaminated and require an autoclave sterilisation 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 packagings
have a double label to record the implant data on the patient sheet.
The other products have instead a single packaging in PVC, thermosealed
by a single layer of tyvek.
BTLock periodically verifies the validity of its sterilisation 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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