A-A-54530
The Mayo tray and stand cover shall be made of a plastic material at least 2.75 roils thick. The tray portion shall be reinforced with a non-woven material measuring 28 inches by 20 inches and shall be impervious to fluids. The cover shall be fan-folded with a 6 inch cuff on the distal end for sterile draping of the Mayo stand.
The four drape towels shall be of a soft non-woven fabric with an adhesive strip the length of the towel for adherence to the skin.
The suture bag shall be made of plastic or a non-woven fabric.
The polyethylene sheet shall be used as a water/fluid barrier. It shall go under the extremity before the drapes are applied.
The extremity sheet shall be approximately 87 by 128 inches long. Shall have a bactericidal fabric reinforcement around the fenestration. The reinforcement area shall measure 27 inches by 46 inches and shall be impervious to fluids yet be highly absorbent, eliminating strike through while preventing pooling of fluids. The remainder of the drape shall be fluid/moisture resistant. Shall be fan-folded to permit aseptic draping of the operative area.
It shall be possible to re-sterilize the pack by ethylene oxide, should the packs be opened and not used.
All non-woven material shall be fabricated of a soft material with a minimal memory for good drapeability. Shall resist tearing, pilling and linting.
The pack shall be sterile and individually wrapped in a 4 mil poly bag. The bag shall be a tear resistant, waterproof, heat sealed package which shall allow aseptic handling.
The manufacturer’s lot number shall be heat-sealed into the poly bag for traceability purposes.
All pack components shall be clearly listed on the exterior wrapper which shall also serve as a dust cover.
Workmanship. The surgical packs shall be free from defects which detract from their appearance or impair their serviceability.
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