COMMERCIAL ITEM DESCRIPTION A-A-51766
Sterility of the catheter needle unit shall be in accordance with the following sterility requirements.
A. Sterility test. The catheter-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 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:
|
Medium Prod. |
Paper spore strip |
Inoc. Prod. or Inoc. Simulated |
|
Soybean-casein digest |
S-3* |
S-3* |
|
Fluid thioglycollate or Alternative thioglycollate |
|
S-3* |
* 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:
|
Type of Sterilization |
Organism |
|
Steam |
B. stearothermophilus |
|
Dry Heat |
B. stearothermophilus |
|
|
B. subtilus |
|
Ethylene oxide |
B. subtilus |
|
Gamma radiation |
B. pumilus |
The number of viable spores shall be sufficient to provide assurance that the product has been sterilized.
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