COMMERCIAL ITEM DESCRIPTION A-A-53045
Patency and leakage. Ten cc of water shall be injected at 45 psig through the proximal lumen without any leakage at the Luer hub and no flow obstruction. The Luer hub shall be attached to a male Luer lock water supply. All Luer fittings shall comply with ANSI/HIMA MD70.1. The same test shall be repeated through the distal port.
Sterility, freedom from pyrogens and non-toxicity. The catheter shall be sterile, non-toxic and pyrogen free. Sterility shall be for in accordance with the clauses shown below. The non-toxicity and non-pyrogenocity shall be in accordance with the USP.
Sampling for tests.
|
Characteristic |
Inspection level |
AQL |
|
Class IV plastic |
S-1 |
* |
|
Balloon leakage |
S-1 |
* |
|
Patency and leakage |
S-1 |
* |
|
Pyrogens |
S-1 |
* |
|
Toxicity |
S-1 |
* |
|
Sterility |
(See sterility clauses) |
|
* Acceptance number shall be zero for all sample sizes.
A. Sterility test. The catheter 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 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.
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