A-A-0051960(DM)
The metering chamber shall be made of clear, transparent cellulose propionate seamless tubing measuring approximately 1-1/4 inches in I.D., 7-1/2 inches long with a wall thickness of 0.022 ± .004 inch. Graduations shall be present at 1 ml intervals; numbering shall be present at 10 ml intervals. The roller clamps shall be made of suitable rigid plastic and the roller shall withstand a 3.65 kg load without being removable from the clamp body.
The piercing device or spike shall be provided with an integrally molded hand grip. The spike shall have a single channel and have a conical tip suitable for leakproof insertion into solution container seals. The spike shall be 7/8 to 1 inch in length and have a base diameter of 0.208 to 0.212 inch.
The inlet tubing shall be 5 to 7 inches long, have an I.D. of 0.120 ± .005 inch and a wall thickness of 0.022 ±.005 inch. All rubber Injection sites shall show no leakage except for one clinging drop at 4 psig water pressure after being punctured by an 18 gage hypodermic needle that has been thoroughly wiped to remove lubricant. All injection sites with rubber plugs shall have the plugs secured so that they are not removable in normal use. There shall be no shoulders in the bores of injection sites to deform the points of hypodermic needles.
The drip chamber shall have an effective volume of 3 to 7 ml measured from the bottom of the chamber to the outlet of the drip orifice. The drip chamber shall be transparent and have a wall that is flexible but sufficiently rigid not to undergo collapse in use.
The outlet tubing shall have an ID of 0.106 ± .005 inch and a wall thickness of 0.022 to .005 inch.
The flash tube injection site shall be molded of natural rubber with a minimum wall thickness of 0.027 inch and be 1-1/2 to 2-1/4 inches long. It shall be provided with a shoulder for injection that is a minimum of 3/8 inch in diameter and preferably a 1/2 inch in diameter. The needle adapter shall be made of suitable plastic and shall have a male Luer taper in accordance with ANSI/HIMA MD70.1. The set shall be subjected to an internal water pressure of 20 psig for 3 minutes and demonstrate no leakage or separation of components.
Sterility lot. A sterility lot is that single quantity of product subjected to the same manufacturing operation and simultaneously sterilized in the same sterilizing chamber. Each unit package shall be clearly marked with a sterility lot (control) number. Each sterility lot shall be traceable to the pertinent manufacturing lot(s).
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