COMMERCIAL ITEM DESCRIPTION A-A-51330
The needle adapter protector cover shall provide a cover to maintain security of the needle adapter end of the check valve prior to use and shall be easily removed without compromising the adapter. Contact with the needle adapter protector shall be by molded levels with a tortuous air path to permit priming the set without removal of the cover.
Performance. A plastic spike protector shall be provided to maintain security of the spike prior to use and shall be easily removable without compromising the spike.
Low volume disc check valve shall be provided to reduce fluid hold up and to assure rapid response to pressure changes. The free floating disc valve shall be open but shall close with reverse flow. The spring-loaded disk check valve shall be closed and shall open under 2 to 4 psi pressure. The hold up volume in each valve shall be 0.2 ml maximum.
The female Luer lock cover shall provide security of the female Luer adapter before use, but shall be easily removable without compromising the adapter.
The fluid path in the tubing and components and internal surfaces of covers shall be sterile, non-pyrogenic and no-toxic when tested in accordance with the United State Pharmacopeia (USP). The tubing, covers and components in direct contact with the blood or fluid flow shall meet the requirements of the USP for Class IV plastics.
Workmanship. The blood platelet administration pooling set shall be free from defects which detract from their appearance or impair their serviceability.
PRODUCT QUALITY LEVEL
Visual and dimensional examination. Shall be examined to verify that design, construction and workmanship are in accordance with the requirements specified.
Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with the requirements specified.
Unit. Package (PG). One package containing forty-eight blood platelet administration-pooling set, each set individually packaged in a container capable of maintaining sterility of fluid path, as specified, 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, examination, and test requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any other 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, examinations, or tests set forth in this description where such inspections, examinations, and tests are deemed necessary to assure supplies and services conform to prescribed requirements.
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