A-A-51468 Intravenous Injection Set, With Flexible Drip Chamber, Non-Vented, Adult, Without Needle, Disposable, 50'sThis 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-51468

The IV set shall withstand an internal hydraulic pressure of 20 psig for five minutes without leakage of no more than one falling drop.

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. End protectors shall be present to maintain sterility. The set shall be packaged in a suitable container to maintain its sterility until the package is opened.

The two Y injection sites and the flash tube shall reseal without a falling drop after puncture and withdrawal of a non-lubricated 18-gage needle. The injection sites, within 10 seconds of needle withdrawal, shall be subjected to an internal pressure of 4 psig for 30 seconds.

A. Sterility test. The catheter and needle unit shall be tested for sterility in 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.

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

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