A-A-53010 Catheter And Needle Unit, Intravenous (16 Gage By 24 Inch Catheter, Radiopaque, Disposable)This commercial item description covers a catheter-into-needle unit suitable for administering intravenous medication.

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COMMERCIAL ITEM DESCRIPTION A-A-53010

Biocompatibility. The catheter and guard sleeve shall comply with the USP Class IV plastic requirements.

Hydraulic pressure test. The catheter when the hub is attached to a Luer fitting with a lumen and the other end sealed shall withstand 45 psig water pressure for two minutes without exhibiting leakage exceeding one clinging water drop.

All components shall comply with the sterility requirements shown below under Sterility test:

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 tip (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 30° to 35°C for one half of the specimens and soybean-casein digest at 20° to 25°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 organism used shall be as listed below:

The number of viable spores shall be sufficient to provide assurance that the product has been sterilized.