A-A-54296
Marking and Surface Preparation. The size of the drill bit, drill sleeve, 5.0 mm pin, and wrench shall be permanently etched on each instrument. Operative ends of the wrench shall be marked to delineate proper application. Additionally, the manufacturer’s name (or registered trademark) and manufacturer’s reference number shall be marked on drill bit, drill sleeve, pins, and wrench. Surface preparation and marking shall be in accordance with ASTM Designation F86.
Each system shall have instruction for application of the device printed on Tyvektm paper. The instructions shall include the following:
a) Description
b) Indications
c) Contents of the package
d) Application technique-Shall be step-by-step instructions with professional diagrams of each step in the application of the device.
All of the components shall be disposable.
Sterilization. The system shall be capable of being sterilized by steam sterilization if the package is opened but not used.
The system shall be packaged sterile with a sterility assurance level of 10-6. The sterilization date shall be visible on the outer surface of the package. The packaged system shall have a minimum storage life of five (5) years.
The packaged system shall be stackable and have a maximum weight of 25 ounces (710 grams).
Unit. Each (EA). One individually packaged, sterile, external, fixation system with instructions for use, as specified, constitutes one unit. The individual package for each system shall be double packaged in a sealed, peel open type container capable of permitting aseptic delivery of the inner container onto a sterile surface.
Workmanship. The external fixation system shall be free from defects.
Visual and dimensional examination. Fixation system shall be examined to verify that the design, construction and workmanship are in accordance with applicable requirements.
Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with requirements specified.
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