A-A-54575
Biocompatibility. Material used in the manufacture of the drainage kit shall meet the requirements of the USP for class IV plastics and USP Interdermal Sensitivity Test.
Workmanship. The item shall be processed in such a manner as to be uniform and free from defects that will affect life, serviceability, or appearance.
Unit. Package (PG). One package containing 5 individually packaged drainage kits of one size only, as specified, constitutes one unit. Each kit shall be individually packaged in a sealed peel-open 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 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.
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.
Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item.
Sampling for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105, and as specified herein. Unit of product for examination purposes shall be one drainage kit. Sampling shall be inspection level II with an acceptable quality level (AQL) of 1.0.
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