A-A-53469
Sterility. The intravenous injection set shall be sterile in accordance with USP or AAMI guidelines. Biological indicator incubation time shall be in accordance with the USP or shall be at least 5 days using procedures in accordance with the FDA Guide for Validation of Biological Indicator Incubation Time.
Pyrogenicity. The intravenous injection shall be non-pyrogenic in accordance with the USP. In lieu of animal pyrogen testing, USP LAL-Bacterial Endotoxins test is acceptable.
Drop test. The intravenous injection set shall be tested at 72 ± 5° Fahrenheit (F), using water at rate of 100 ± 5 drops per minute. The number of drops required to deliver 5 milliliters (ml) shall be counted, and the drops per ml calculated. The number of drops per ml shall be 15 ± 3.
Piercing device (spike) durability test. The piercing shall be immersed for 4 hours in a solution of USP dextrose and sodium chloride. The piercing device shall be removed from the solution and immediately inserted into a standard solution container (See Note 2). The piercing device shall not loosen, become damaged, or permit leakage after insertion.
Security of roller in clamp body. The roller clamp shall be removed from the set together with a piece of tubing approximately one inch longer that the clamp body. The tubing shall be present in the roller clamp in its normal position with a 1/2 inch length extending from each end of the roller clamp. The clamp shall be held vertically with the large end down, over a supporting gap so that the roller, if forced out of the body, is free to fall. A polished steel rod is applied to the top of the roller, so that the roller is able to rotate in the course of the test, and the vertical downward force required to separate the roller from the clamp body is measured. The roller shall withstand a 3.65 kilogram load without being separated from the clamp body. (See figure 1).
Instructions. Each intravenous injection set shall be provided with complete instructions for use.
Workmanship. The intravenous injection set shall be leakproof and free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing 50 intravenous injection sets, each set individually packaged sterile, as specified, constitutes one unit. The individual package shall be a sealed, peel open type container capable of maintaining sterility of contents unless package is damage or openend.
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