COMMERCIAL ITEM DESCRIPTION A-A-51546A
Physical properties. Tubing shall be tested for breaking strength in accordance with Federal Test Method 4111 of Federal Test Method Standard 601. Breaking strength shall be the value of breaking force as defined in Method 4111. Drains shall have a minimum breaking strength of 32 pounds force.
In addition, drains shall be subjected to accelerated aging in accordance with Federal Test Method 7221 of Standard Number 601. The aged drains shall be tested for breaking strength as specified above. The breaking strength of the aged drain shall not be less than 75 percent of the value obtained from the unaged specimens cut from the same drain.
Sterility and freedom from pyrogens. Drains shall be sterile and free from pyrogens. Drains shall be tested for sterility and freedom from pyrogens in accordance with the United States Pharmacopeia (USP). Freedom from pyrogens may be tested by the USP Pyrogen Test or Bacterial Endotoxin Test.
Biocompatibility. Material used to manufacture the drains shall be tested in accordance with the Intracataneous and Intramuscular Implantation tests of the USP.
Workmanship. The drains shall be free from defects which detract from their appearance.
Unit. Package (PG). One package, containing ten individually packaged drains, constitutes one unit. Each drain shall be packaged sterile in a sealed peel-open type container capable of maintaining sterility of contents unless the container 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.
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