A-A-51424B
Unit. Package (PG). One package containing ninety-six individually packaged covers, as specified, constitutes one unit. The individual package shall be a sealed, peel or tear 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 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.
Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics.
Sampling for tests. Sampling for tests, including dimensional tests, shall be conducted in accordance with MIL-STD-105, with an AQL of 1.0 (percent defective) and an inspection level of S-1. The unit of product for test purposes shall be one surgical instrument stand cover.
Tests.
Sterility. Sterility testing shall be in accordance with the FDA’s current Compliance Program Guidance Manual- Sterilization of Medical Devices and General Principles of Process Validation.
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