A-A-51363A
Physical properties. The drain shall show no visible evidence of deterioration (surface brittleness and
tackiness) and shall not show a decrease of greater than 25 percent in ultimate elongation and breaking strength when subjected to the Standard Test Method for Rubber - Deterioration in an Air Oven, ASTM Designation D573.
Sterility. The surgical drain shall be sterile when tested in accordance with the USP or AAMI guidelines. Sterility Assurance Level shall be 0.000001.
Identification marking and labeling. Each drain shall be legibly and permanently marked with name of manufacturer or registered trademark, French size, and date of manufacture (year, month).
Labeling. Labeling shall conform with the requirements of the Federal Food, Drug and Cosmetic Act, and in addition the label of the immediate container shall identify the T-tube cross bar length, French size, contractor’s name or trademark and the legend “sterile”.
Workmanship. The drain shall be processed in such a manner as to be uniform in quality and free from defects that will affect life, serviceability, or appearance. Surfaces and ends of the drain shall be smoothly finished to prevent irritation in patient.
Unit. Package (PG.). One package containing 10 individually packaged drains of one size only, as specified, constitutes one unit. Each drain shall be individually packaged sterile in a sealed peel-open container capable of maintaining sterility of contents unless package is damaged or opened. The sealed container shall be designed to permit ready dispensing of the T-tube drain by sterile techniques.
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, examination, and test requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any other 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, examinations, or tests set forth in this description where such inspections, examinations, and tests are deemed necessary to assure supplies and services conform to prescribed requirements.
For Parts Inquires call Parts Hangar, Inc (727) 493-0744
© Copyright 2015 Integrated Publishing, Inc.
A Service Disabled Veteran Owned Small Business