A-A-30099D
Material. The tray shall be fabricated from inert plastic and absorbent balls or swab tips shall be of natural cotton or viscose rayon. Underpad and fenestrated drape shall be absorbent and waterproof and fabricated from three-ply, laminated facial tissue or other suitable non-woven material. Underpad shall be coated on one side or backed with suitable plastic film to provide an impermeable barrier. Syringe and forceps shall be fabricated from suitable plastic.
Sterility. The components and internal surfaces of the package shall be sterile in accordance with the USP or AAMI requirements. Sterility assurance level shall be 0.000001.
Instructions. Each kit shall contain procedural instructions for use. In addition, all medical devices within the kit that contain natural rubber latex which comes directly or indirectly in contact with the body shall be identified on the principal display panel with the words “THIS PRODUCT CONTAINS NATURAL LATEX RUBBER.” or where there is a concern about an allergic reaction, a similar statement, such as, THIS PRODUCT CONTAINS NATURAL LATEX RUBBER WHICH MAY ALLERGIC REACTIONS IN SOME INDIVIDUALS.”
Workmanship. The catheterization kit shall be free from defects which detract from its appearance or impair its serviceability. Components and tray shall be free from cuts, tears, holes, sharp edges, burrs, flash and foreign material.
Unit. KIT (KT). One catheterization kit packaged sterile, as specified, constitutes one unit. Components shall be packaged in tray in reverse sequence of use (i.e. first used components on top). For Type I kit, the tray shall be CSR wrapped with a moisture resistant outer drape, minimum 48 x 51 cm, and overwrapped in protective plastic pouch, packaged to remain sterile until time of use. For Type II and III kits, the individual package shall be a sealed, peel-open type container capable of maintaining sterility of contents unless package is damaged or opened. For Type IV kits, the tray shall be CSR wrapped 50.8 x 50.8 cm and inserted in a peel-open type polybag to remain sterile until use. Catheterization kit shall be examined to verify that design, construction and workmanship are in accordance with applicable requirements.
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 contract or purchase order, the contractor may use his own or any facilities suitable for
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