A-A-30056E
field. A tear-open type package shall not be acceptable. The label of immediate container shall bear the word “sterile”.
Salient characteristics. Size – B The specimen cup shall be a sterile, disposable, translucent, polystyrene or polypropylene container of 4-1/2 ounces plus or minus 1/4 ounce capacity, suitable for the collection of laboratory specimens. The cup shall be supplied with a screw cap which shall form a lealproof closure with the cup when tested as specified. The full cup shall be stable when placed on a flat, level surface.
The cup shall be circular in section, a nominal 2-1/2 inches in diameter and a nominal 2-1/2 inches in height. The cup shall be graduated in 1/4 ounce steps over a minimum range of 20 ml to 110 ml. Graduation numbers and lines shall be free from waviness that obliterates the lines of numerals.
The cup shall be threaded to mate with the threads on the cup. The screw cap shall fit the cup securely, shall be capable of being easily installed and removed from the cup, and shall form a tight seal to prevent spillage of contents.
The cup nad cap shall be free from holes, pits, scratches, burrs, and abrasions. They shall be free from objectionable odor, water drops or dried stains, oil or grease smears, or dirt or loose particles, on either inside or outside.
One cup and one cap together shall be sealed in an individual clear plastic container or envelope of a peel-open type. This plastic container or envelope shall maintain the sterility of the contents until manually opened. It shall also permit aseptic handling of the cup and delivery of the cup uncontaminated, onto a sterile field. A tear-open type package shall not be acceptable. The label of the immediate container shall bear the word “sterile”.
The plastic container or envelope shall be properly sealed to maintain sterility of contents. It shall be free of cuts or openings which permit entry of dust or foreign matter and strong enough to avoid holes, perforations, or tears during shipment and handling.
Labeling shall be that usually furnished by the supplier as commercial practice. Addition to these labels be limited to application of the following to the unit of issue (strip labeling is acceptable):
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