A-A-51509 Tube, Tracheal, Radiopaque (Murphy)This Commercial Item Description covers disposable Murphy-type tracheal tubes commonly used in human patients in the practice of anesthesiology and in respiratory care.

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A-A-51509B

The tracheal tubes shall be supplied sterile and shall be disposable. The Luer fitting on the inflation valve shall be in accordance with ANSI/HIMA MD70.1, Standard for Medical Materiel Luer Taper Fittings or IS0 594. Each tracheal tube shall be provided with a 15 millimeter (mm) tracheal tube straight connector.

Material. The tracheal tube, tracheal tube cuff, the inflation valve, and the pilot balloon shall be fabricated of a polyvinyl chloride plastic material or other suitable plastic medical acceptable material meeting requirements of ANSIZ79.14 or ASTM F1242-89. Tube material shall conform to the United States Pharmacopoeia (USP) requirements for Class IV plastics. The poppet shall be fabricated from neoprene or other suitable material meeting requirements of ANSIZ79.14 or ASTM F1242-89. If a valve spring is used, it shall be fabricated of AISI 300 Series corrosion-resistant steel.

The connector shall be fabricated of polypropylene or other suitable plastic and shall comply with the requirements of Z79.2 American National Standard for tracheal tube connectors and adapters or ASTM 1242-89. The tracheal tubes shall have a radiopaque stripe extending the entire length of the tube.

Leakage. The cuff and inflation system shall show no evidence of leakage when it has been inflated to an air pressure of 22 mm Hg for not less than 30 minutes.

Lead content. The tracheal tube and cuff shall contain not more than 5 parts per million of lead.

Sterility. The tracheal tube and connector shall be sterile in accordance with the USP or AAMI guidelines. Sterility assurance level shall be .0001.

Pyroqens and safety. The tracheal tube shall meet the USP requirements for pyrogenicity and safety.