A-A-531C)3A
Certificates of biocompatibility. A certificate of compliance, stipulating that offered item meet the biocompatibility test, shall be acceptable, provided that the contractor has supplied acceptable items to the Government within the past three years and that there have been no changes to material formulation and the method of processing since actual testing was performed. The certificate shall include the date the testing was performed, the test method and results, the name and title of the person evaluating the results, the current contract, contract number and NSN, a statement certifying, that the material processing and formulation have not changed since the time that biocompatibility was performed and the signature and title of the person making the certification.
Minimum full time test. Completely aspirate and discharge the syringe with water continuously for 10 cycles. On the tenth cycle measure the time to aspirate the syringe. The maximum time required to fill the syringe on the tenth aspiration shall be 2.5 seconds for 2oz. syringe and 3.6 seconds for 3oz. syringes.
Workmanship. The aspirating syringe set shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing fifty syringes of one size only constitutes one unit. Each syringe shall be packaged sterile in s sealed peel-open type 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 otherwise specified in the contract 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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