COMMERCIAL ITEM DESCRIPTION A-A-51464
Flow rate test. Mount the reservoir by the strap above a supply basin of water at room temperature such that a hydrostatic head of 7 ± 1/8 inches exists from the water level in the basin to the entrance of the reservoir. The reservoir may be held by a mechanism other than the strap as long as the reservoir shape recovery and the vacuum induced are not influenced by the mechanism and the 7 inch head is maintained. Manually or mechanically evacuate the air from the reservoir, install the reservoir drain plug, and release the reservoir. The reservoir shall collect 33-45 ml of water in 2 minutes.
Sterility and Pyrogenicity. Tubes shall be sterile and free from pyrogens. Tubes shall be tested for sterility and pyrogenicity in accordance with the United State Pharmacopeia (USP).
Biocompatibility. Material used in the manufacture of the reservoir shall be tested in accordance with the USP Muscle Implantation Test and USP Intradermal Sensitivity Test.
Workmanship. The item shall be processed in such a manner, as to be uniform and free from defects that will affect life, serviceability, or appearance.
Unit. Package (PG). One package containing ten sterile reservoirs, each reservoir individually packaged in a suitable peel-open type container capable of maintaining sterility of contents unless package is damaged or opened, as specified, constitutes one unit.
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.
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.
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