A-A-0051960(DM)
TABLE III. Classification of Defects.
|
Categories |
Defects |
|
Major |
|
|
101 |
End protectors or other components missing or dislodged. |
|
102 |
End protectors not properly designed to permit flow of sterilizing gases, if used. |
|
103 |
Not free of bloom or tackiness. |
|
104 |
End protectors not properly designed to maintain sterility. |
|
105 |
Style and design not as specified. |
|
106 |
Presence of foreign matter. |
|
107 |
Set not free of holes or cuts. |
|
108 |
Dimensions not as specified. |
|
109 |
Packaging, packing and marking not as specified. |
|
110 |
Instructions missing, incomplete or illegible. |
|
Minor |
|
|
201 |
Contractor’s name or registered trademark, missing, incomplete, or illegible. |
A. Sterility. The intravenous injection 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° 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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