A-A-54419
Residual Ethylene Oxide. If ethylene oxide is used as a sterilization agent, the finished gauze shall contain not more than 250 ppm of Ethylene Oxide, 250 ppm, Ethylene Chlorohydrine and 5000 ppm, Ethylene Glycol. Petrolatum Gauze shall be tested by methods 54, 55, or 56 published in the Federal Register, Volume 43, No. 122, Part V, 22 June 1978, Ethylene Oxide, Ethylene Chlorohydrine, and Ethylene Glycol, Proposed Maximum Limits and Maximum Levels of Exposure. Contractor shall satisfactorily demonstrate that he has the capability to meet specification requirements for residual testing for the product. A satisfactory test report from a recognized independent testing laboratory shall be considered as an acceptable means for demonstrating his capability. Note: A manufacturer who has demonstrated his ability to use Ethylene Oxide sterilization without excessive residuals present in the final product may confirm his sterilization method on the basis of an approved auditing schedule in lieu of lot-by-lot testing. Prior approval shall be obtained from the contracting officer.
Workmanship. The dressings shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Package (PG). Each dressing shall be individually packaged in a peel-open type container capable of maintaining sterility of contents unless package is damaged or opened. One package containing 12 individually packaged dressings 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.
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