A-A-51438 Drainage Unit, Pleural CavityThis Commercial Item Description describes underwater and gravity chest drainage units, pleural, which accompany most heart and lung operations, and are utilized for a variety of medical conditions shall be Type I, Type II or Type III as described herein.

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A-A-51438B

Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for determination of two or more test characteristics. As a minimum, the following tests shall be performed on types shown.

Sampling for tests. Sampling for tests including dimensional test shall be conducted in accordance with MIL-STD-105 and as specified. Unit of product for test purposes shall be one package of 6 drainage units. Sampling shall be inspection level II with an AQL of 1.0.

For Type III. Using standard laboratory testing equipment, with the water seal chamber filled to the 2 cm level and the thoracic drain tube laying on a horizontal surface no more than 15 cm above the top of the drainage apparatus, apply a negative air pressure of (-) 25 cm H₂O at the patient end of the thoracic drain tube for a 12 second time period. If air passes by the water seal, the unit is rejected.

For all Types. Perform other tests as appropriate to assure conformance with this description and with ASTM F960.

Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.

Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerances specified using conversion tables contained in the latest revision of Federal Standard 376, and all other requirements of this document are met.

If a product is manufactured to metric dimensions and those dimensions exceed the tolerances specified in the inch/pound units, a request should be made to the contracting officer to determine if the product is acceptable.

The contracting officer has the option of accepting or rejecting the product.