A-A-51886 Intravenous Injection Set, (With Flexible Drip Chamber, Non-Vented, Adult, Without Needle, Disposable)This commercial item description covers a single type of non-vented intravenous injection set used in administering parenteral solutions from glass containers with airways or flexible bags.

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COMMERCIAL ITEM DESCRIPTION A-A-51886

The roller shall not be able to be forced out of the clamp body under a 3.65 kg load applied axially and toward the open end of the clamp. The end protectors shall maintain the sterility of the fluid path and the exterior of the spike and Luer taper. The set shall be contained in a package that will maintain the sterility of the set unit the package is opened.

The Y and flash tube injection sites shall reseal without a falling drop after puncture and withdrawal of an 18-gage unlubricated needle. The resealing shall occur within 10 seconds of needle withdrawal. An internal water pressure of 4 psig shall be used in the conduct of this test.

A. Sterility test. The intravenous injection set shall be tested for sterility inn accordance with the method specified in the USP using inoculated product, inoculated simulated product, or paper spore strip (carrier). Product containing a biological indicator shall be marked or labeled so that it is clearly differentiated from product intended for distribution. The incubation medium for the paper spore strip (carrier) shall be soybean-casein digest. The incubation medium for the inoculated product or inoculated simulated product shall be fluid thioglycollate or alternative thioglycollate at 30⁰ to 35⁰ C for one half of the specimens and soybean-casein digest at 20⁰ to 25⁰ C for the remaining half of the specimens. The minimum incubation time shall be ten days. Sampling shall be as follows:

*Use a minimum of 20 specimens. Acceptance number is zero.

B. Inoculated product or simulated product. For each type of sterilization, the organisms used shall be as listed below: