A-A-53382
Sterility. Testing for sterility shall be accomplished by the use of biological indicators or by indicators which provide a statistical correlation to the use of biological indicators showing the probability of viable microorganisms to be less than 1x10-6. The biological indicators selected shall be able to provide An adequate challenge to the method of sterilization and are listed below:
|
Method of Sterilization |
Organism |
|
Steam |
B. stearothermophilus |
|
Dry heat |
B. stearothermophilus |
|
|
B. subtilis |
|
Ethylene oxide |
B. subtilis |
|
Gamma radiation |
B. pumilus |
Sterility testing shall be accomplished on a minimum of 20 samples. AAMJ Guidelines for Biological Indicators, sterilization Methods, Sterilization Validation, and Sterility Testing shall be followed.
Workmanship. The suction tube shall be free from defects which detract from its appearance or impair its serviceability.
Product Quality Level.
Visual and dimensional examination. Shall be examined to verify that design, construction and workmanship are in accordance with applicable requirements.
Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with requirements specified.
Certificates of biocompatibility. A certificate of compliance, stipulating that offered items 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 method of processing since actual testing was performed. The certificate shall include the date of actual testing, the test method and results, the name and title of the person evaluating results, the current contract number and NSN, a statement to the effect that material processing and formulation have not changed since actual testing was performed, and the signature and title of the person making the certification.
Unit. Each (EA). One suction tube, as specified, constitutes one unit.
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