Schedule F(II) of the Drugs and Cosmetics Rules, 1945, specifies standards for surgical dressings, including bandage cloth and absorbent gauze. These standards ensure that medical textiles meet specific quality and safety criteria for clinical use.
Bandage Cloth Specifications:
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Material: Cotton cloth of plain weave made from machine-spun yarn.
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Yarn Count: Bleached count between 20 tex and 25 tex for warp; between 25 tex and 30 tex for weft.
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Threads per Decimeter: Warp: not less than 150; Weft: not less than 85.
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Weight: 57 ± 5 grams per square meter.
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Dimensions: Length and width shall not be less than 99% of the stated measurements on the label.
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Foreign Matter: Not more than 2%.
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Fluorescence: When viewed under screened ultraviolet light, not more than occasional points of fluorescence are observed.
Absorbent Gauze Specifications:
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Material: Cotton fabric of plain weave, bleached, free from sizing, dressing, or filling materials.
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Yarn Count: Bleached count between 17 tex and 25 tex in the finished fabric.
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Threads per Decimeter: Warp: not less than 75; Weft: not less than 55.
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Weight: 30 ± 5 grams per square meter.
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Dimensions: Length and width shall not be less than 98% of the stated measurements on the label.
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Absorbency: Average sinking time not more than 10 seconds.
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Foreign Matter: Not more than 1%.
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Fluorescence: When viewed under screened ultraviolet light, not more than occasional points of fluorescence are observed.
Packaging and Labeling:
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Products should be securely packed to protect their absorbency and allow normal handling and transport without tearing or exposing the contents.
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The net content must be stated on the label in terms of length and width.
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Packages should be prominently labeled with the words "Non-Sterile." If sterile, it should be stated on the label, and the packaging method and material should maintain sterility.
These standards are designed to ensure that surgical dressings are safe, effective, and suitable for medical use.
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