A-A-54295A
Connectors bonding strength. The bonded connectors shall withstand a pull force of 10 lbs without separation from the tubing.
Sterility. The suction tube shall be sterile in accordance with the USP or AAMI guidelines. Sterility assurance level shall be 0.0001.
Workmanship. The suction tube shall be free from defects which detract from its appearance or impair its serviceability. The tube shall be free of cuts, rough areas, flash, weak areas, discoloration and foreign matter.
Unit. Package (PG). One package containing 20 individually packaged sterile suction tubes, as specified, constitutes one unit. Tubing shall be housed in an inner package of a type to permit aseptic handling when outer package is opened. The individual package shall be a sealed peel-open container capable of maintaining sterility of contents unless package is damaged or opened.
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.
Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item.
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