A-A-0051837(DM)
Drape and outerwrap shall be enclosed in a sealed paper or plastic immediate container capable of maintaining sterility of contents until manually opened. If the sealed container is paper, it shall be further enclosed in a plastic bag.
The drape and outerwrap in its immediate container shall be sterile when tested with a biological indicator (or alternate method) as specified in the sterility test.
A certificate of sterility stating the samples from each sterilization lot have been tested and found to be sterile, shall be submitted to the procuring activity. The certificate of sterility shall include:
a. Item Identification.
b. National Stock Number.
c. Contact or purchase order number.
d. Sterility lot or control number.
e. Date of sterilization.
f. Quantity of product in the sterilizer lot.
g. Type sterilization (gas, radiation, heat, steam, etc.)
h. Form of biological indicator (i.e. inoculated paper spore strip or carrier, inoculated product, or inoculated simulated product).
i. Test organism(s) and population density used.
J. Test medium, incubation temperature, incubation time, and dates of test.
k. Number of test units.
l. Signature that samples comply with sterility test.
m. Signature of head of laboratory or a designated qualified alternate.
Workmanship. The surgical drape shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing twenty-two individually packaged sterile drapes with an outerwrap for each drape, as specified, constitutes one unit.
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