COMMERCIAL ITEM DESCRIPTION A-A-51294A
Each unit shall be provided with a component necessary to protect the entire length of the catheter and needle cannula during handling.
Catheters shall not pull out of, of loosen from, the catheter hub when subjected to an axial force of 3.0 pounds. Catheters shall not exhibit leakage exceeding one clinging drop ( hydrostatic test) or one clinging air bubble (pneumatic test) when tested with appropriate fixtures and taper test gages. The criteria shall be as follows:
Hydrostatic test – 20 pounds per square inch gage (psig) pressure applied for 2 minutes.
Pneumatic test – 10 psig applied for 1 minute.
The needle cannula shall not pull out of, or loosen from, the needle hub when subjected to an axial force of 10 pounds.
Precautionary statement. A caution note shall appear on the label that shall state the following: “Do not reinsert needle in catheter if venipuncture is not successful” (or similar wording).
Workmanship. The catheter and needle placement unit shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Package (PG). One package containing fifty catheter and needle units, each unit individually packaged in a container capable of maintaining sterility of contents unless package is damage 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, 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.
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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