A-A-51978 Catheter And Needle Unit, Intravenous (20 Gage)

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COMMERCIAL ITEM DESCRIPTION A-A-51978

The catheter shall not exhibit leakage exceeding one clinging drop when tested in accordance with 5.2.1 Test for Water Leakage of ANSI/HIMA MD70.1.

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 strip (carrier). Product containing 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 hioglycollate 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.