COMMERCIAL ITEM DESCRIPTION A-A-51872
Suture shall be sterile in accordance with the USP. Sutures shall have at least 50 months of the original shelf-life remaining at the time of delivery to the Government. Sutures shall be packaged sterile inside an inner container made of aluminum foil and/or plastic. The inner container shall be packaged sterile inside an outer container of the peel-back opening type as shown in Figure 1. The inner container shall show no evidence of leakage when tested as specified in ASTM D3078. Inner and outer containers shall maintain sterility throughout the shelf-life. Each inner container shall have a label identifying the suture material, size, length, number of arms, needle circle, needle point, and the legend “sterile”.
Workmanship. Sutures shall be free from frays and other defects which detract from their appearance or impair their serviceability. Needles shall be bright and smooth, and free of feathered edges, cracks, burs, and other defects.
Unit. Package (PG). One package containing 36 individually packaged single-armed sutures, or 109 unarmed sutures packed 3 to a packet, or 432 unarmed sutures packed 12 to a packet, of one size only, 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 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.
Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon the Government’s request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate.
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