COMMERCIAL ITEM DESCRIPTION A-A-51694
Product Quality Level.
Visual and dimensional examination. Shall be examined to verify that design, construction and workmanship are in accordance with applicable requirements.
Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with requirements specified.
Unit. Each (EA). One stopcock, individually packaged sterile in a suitable tear resistant, peel-open type container capable of maintaining sterility of contents unless package is damaged or opened constitutes one unit.
Quality Assurance Provisions.
Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contact or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.
Leakage. Luer connectors shall be tested in accordance with the Test for Water Leakage of ANSI/HIMA MD70.1 except that the 45 psi pressure shall be maintained for three minutes. The outlet valve described in ANSI/HIMA MD70.1 shall be the rotating member of the stopcock. In addition to the requirements of ANSI/HIMA MD70.1, there shall be no leakage sufficient to form a falling drop from the rotating member-stopcock body juncture.
Security of assembly. Luer connectors shall be tested in accordance with ANSI/HIMA MD70.1 Test for Resistance to Separation and Unscrewing. In addition, the stopcock body shall be secured and an 8 pound (minimum) tensile force applied to the rotating member. The rotating member and the body shall show no signs of breakage, nor shall be the rotating member separate from the stopcock-body.
Clear passage of fluids. The test apparatus used in the leakage test shall be connected to the stopcock shall be closed and a pressure of 3.5 psi applied. The stopcock shall then be opened. There shall be clear passage of water within 2 seconds of opening the stopcock.
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