A-A-54324 Airway, Nasopharyngeal (Argyle)This Commercial Item Description covers an Argyle nasopharyngeal airway suitable for use in bedside bronchofiberoscopy, nasopharyngeal suction, or use as an airway.

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A-A-54324

Sterility. The airway shall be sterile in accordance with the United States Pharmacopeia (USP) for Sterile Devices. As an alternate, AAMI Guidelines for Biological Indicators, Sterilization Methods, Sterilization Validation, and Sterility Testing shall be followed. Sterility assurance level shall be 0.000001

Toxicity and biocompatibility. The toxicity and biocompatibility of the airway shall be in accordance with ANSI.Z79.3.

Certificates of compliance. 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 with the past three years and that there have been no changes to material formulation and method of processing since the actual testing was performed.

The certificate shall include the date of testing was performed, the test method and results, the name and title of the person evaluating the results, the current contract number and NSN, a statement certifying that 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.

Workmanship. The airway 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 the 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.

Unit. Package (PG). One package containing ten individually packaged sterile airways, as specified, constitutes one unit. The individual package shall be a sealed, peel-open type container capable of maintaining sterility of contents unless the container is damaged or opened.