COMMERCIAL ITEM DESCRIPTION A-A-51951
(1) 24-hour water absorption.
(2) Use die B for testing.
(3) Represents the total concentration of heavy metals.
(4) Perform the systematic injection test at Class IV testing. See “Biological Tests Plastics”.
Thermal stability. The retinal implant tire shall pass the thermal stability test specified herein.
Thermal stability test. Subject sample implant tires to cyclic steam autoclaving in a high speed sterilizer at 270°F and 30 psig for 10 ± 1/2 minutes. Use a total of 10 cycles. After each cycle, examine the samples for blooming, warpage, wrinkles, or tackiness.
As an alternate, implant tire samples may be steam autoclaved in a standard gravity sterilizer at 250°F and 15 psig for 30 ± 1/2 minutes. Complete this version of the test by following the examination and cycling and procedure listed above.
Sterility. The retinal implant tire shall be sterile when tested in accordance with the latest edition of the USP.
Finish. The retinal implant tire shall have a smooth, uniform finish.
Workmanship. The retinal implant tire shall be free from blooming, blisters, fish-eyes, frosting, pits, pimples, shorts, warpage, wrinkles, and any other defects which detract from their appearance or impair their serviceability. Definitions of defects listed above shall be in accordance with ASTM D883, “Standard Definitions of Terms Relating to Plastics”.
Unit. Package (PG). One package containing five individually packaged sterile retinal implant tires, as specified, constitutes one unit. The individual package shall be a peel-open type container capable of maintaining sterility of contents unless the 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.
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