Packaging and storage— Gauze Bandage that has been rendered sterile is so packaged that the sterility of the contents of the package is maintained until the package is opened for use.

Labeling— The width and length of the Bandage, the number of pieces contained, and the name of the manufacturer, packer, or distributor, are stated on the package. The designation “non-sterilized” or “not sterilized” appears prominently on the package unless the Gauze Bandage has been rendered sterile, in which case it may be labeled to indicate that it is sterile and that the contents may not be sterile if the package bears evidence of damage or if the package has been previously opened.

Thread count— Count the number of warp and filling threads of it in areas of 1.27 cm (½ inch) square at 5 points evenly spread along the center line of the Bandage, no point being within 30.5 cm (12 inches) of either end of the Bandage, and calculate the average number of threads per 2.54 cm (1 inch) in each direction. A variation of not more than 3 threads per inch is allowed in either warp or filling, provided that the combined variations do not exceed 5 threads per square inch.

Width— Measure its width at each of the 5 points selected for the determination of the thread count: the average of 5 measurements is not more than 1.6 mm (1/16 inch) less than the labeled width of the Bandage.

Length— Measure the length of the unrolled Gauze Bandage, smoothed without tension, along the center line of the Gauze Bandage: the length is not less than 98.0% of the labeled length of the Bandage.

Weight— Weigh the entire Bandage: the calculated weight in g per 0.894 square meter (1 linear yard Type I gauze), using the measurements obtained as described in the two paragraphs just preceding, is not less than 39.2 g.

Absorbency— Hold a rolled Gauze Bandage horizontal to and almost in contact with the surface of water at 25, and allow it to drop lightly upon the water: complete submersion takes place in not more than 30 seconds.

Sterility 71: Gauze Bandage that has been rendered sterile meets the requirements.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements of the tests for Ignited residue, Acid or alkali, and Dextrin or starch, in water extract, Residue on ignition, Fatty matter, and Alcohol-soluble dyes under Absorbent Gauze.

Expert Committee : (GTMDB05) General Toxicology and Medical Device Biocompatibility

USP29–NF24 Page 238

Phone Number : 1-301-816-8339