COMMERCIAL ITEM DESCRIPTION A-A-51409
The proximal end shall be enlarged to form a funnel type connector. The extreme proximal end shall be beveled. The beveled portion shall be 1.70 ± 0.30 inches in length. The tube shall have a radiopaque stripe throughout its length. The stripe need not extend onto the enlarged proximal end.
The distal end shall have five to six oval eyes which open into the lumen of the tube. The eyes shall be placed symmetrically around the tube within 4.0 inches from the distal tip. Eyes shall be uniform in size and shall have a corrosion-sectional area equal to 60-70 percent of the cross-sectional area of the lumen. The radiopaque stripe shall be interrupted to show the location of the most proximal eye.
Tubes shall bear the manufacturer’s name or registered trademark and the French size on the proximal end. Tubes shall be graduated in 2 cm increments beginning 2 cm from the most proximal eye.
X-ray Opacity test. The drainage tube shall be placed on an unexposed X-ray plate and covered with an aluminum ladder ranging in thickness from at least 1/8 inch to 3/4 inch, in steps of 1/8 inch. X-ray exposure shall be as listed below; accomplished with automatic processing and using appropriate speed screens in a convenient size cassette:
|
Milliampere-seconds |
(MAS) |
10 |
|
Peak Kilovolts |
(KVP) |
65 to 70 |
|
Focal length |
(inches) |
30 to 40 |
The tube shall show a definite shadow which clearly delineates the steps 1/4 inch, 3/8 inch, 1/2 inch and 5/8 inch from other.
Physical Characteristics: Tubes shall have a tensile strength of 1500 psi (min) and an ultimate elongation of 225 percent (min). Tubes shall be tested for tensile strength and elongation in accordance with ASTM D638. Tubes shall have a hardness of 77 ± 5 A Shore Durometer. Material shall be tested for hardness in accordance with ASTM D2240.
Toxicity. Plastic material shall meet the requirements of the United States Pharmacopeia (USP), for Class IV plastics.
Sterility. Tubes shall be processed in such a manner as to be uniform and free from defects that will affect life, serviceability, or appearance. The interior and exterior of the tube shall be smooth and free from debris, foreign matter, and scratches or nicks.
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