A-A-51370C
* Adhesive are shall be around a U-slot which shall be 6-3/8 by 19-1/4 inches.
** There shall be an aperture of 3-1/4 by 4-1/4 inches.
*** Cotton adhesive strip 1-1/4 inches wide at top. Circular aperture 1-7/8 inches in diameter.
**** Drape has a 2-1/4 inch diameter center circle aperture.
Tolerances on the above overall dimensions and adhesive area dimensions:
0 – 2 inches – plus or minus 1/8 inch.
Over 2 inches to 12 inches – plus or minus 1/4 inch.
Over 12 inches to 24 inches – plus or minus 1/2 inch.
Over 24 inches to 36 inches – plus or minus 2 inches.
Over 36 inches – plus or minus 3 inches.
Variations 10 percent beyond the above tolerances are permissible in the plus direction only for overall dimensions. Adhesive area dimensions may be under or over by 10 percent.
The drape shall be a sheet of plastic film with a thickness of not less than 0.0012 and a minimum ultimate tensile strength of 1.5 pounds per square inch. One side of the film sheet shall be coated with a translucent, non-rubber co-polymer adhesive (adhesive area dimensions) which shall be pressure-sensitive and chemically inert. A protective liner shall cover the adhesive, shall be easy to remove, and shall not lift off any of the adhesive upon removal.
The drape shall be sufficiently transparent to permit a clear view of the operative and surrounding areas and shall be suitable for use with x-ray equipment without removal. The drape shall be easily applied adhere uniformly, and permit incision directly through the sheet. The drape shall be non-irritating and shall peel-off easily without leaving residue. The drape shall be treated to reduce build-up of static electricity during handling of application and shall comply with NFPA 99, Health Care Facilities Code.
The components and internal surfaces of each drape package shall be sterile and in accordance with the USP or AAMI requirements. Sterility assurance level shall be 0.000001. Each drape shall be individually packaged in a suitable container to permit easy opening under septic conditions and shall maintain sterility until opened.
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