A-A-0051921(DM)
The tubing shall have a minimum ultimate tensile strength of 2800 psi and ultimate elongation of 250%.
The tubing shall have a 100% modulus of 1000 to 1900 psi determined by the tensile reading at the moment the tubing has been stretched to twice its original length.
A. Sterility test. The infusion set 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 |
Paper spore strip |
Inoc. Prod. Or Inoc. Simulated Prod. |
|
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. subtilis |
|
Ethylene oxide |
B. subtilis |
|
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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