A-A-54382
Material. The glass ampuls shall be Type I or Type III, style 7, prescored, meeting the requirements of the Pharmacopeia of the United States (USP). The ampuls shall be made of molded glass or drawn glass tubing, with walls of uniform thickness with drawn, rolled-in, or stuck-on necks. Ampuls shall stand upright, at right angles to the supporting surface, without wobbling. Ampuls shall be suppied ready for opening and shall break cleanly.
The plastics shall meet the requirements of the USP for Class II plastics.
The needles shall be austenitic and in accordance with ASTM Designation F899. The needles shall be furnished with protectors.
The components of the set shall be within opaque packaging capable of maintaining the sterility of the tray and contents until manually open.
The anesthesia sets shall be furnished with no less than 20 months to the expiration date at the time of delivery to the Government.
Sterility. Components shall be sterile in accordance with USP or AAMI guidelines and have a minimum sterility assurance level of 0.000001.
Workmanship. The anesthesia sets shall be free from defects which detract from their appearance or impair their serviceability. Needles shall be without burrs or signs of corrosion.
Unit. Package (PG). One package containing ten packaged sterility anesthesia sets, as specified, constitutes one unit. The package container shall be capable of maintaining sterility of contents unless the package is damaged or opened.
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