YY/T 0331-2024
Performance requirements and test methods for absorbent cotton gauze and absorbent cotton viscose blended gauze (English Version)

Standard No.

YY/T 0331-2024

Language

Chinese, Available in English version

Release Date

2024

Published By

Professional Standard - Medicine

Latest

YY/T 0331-2024

Replace

YY/T 0331-2006

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Introduction

Core changes in the standard revision

New/modified items	Requirements for the 2024 version	Requirements for the 2006 version	Technical significance
Residual ethylene oxide	≤10μg/g	No regulation	Reduce the risk of sterilization residues
Biological burden	Limits to be labeled	No requirements	Guide sterilization parameter setting
Sterility requirements	Comply with YY/T0615.1	Not specified	Unify with medical device standards
Surfactant	Foam does not cover the liquid surface	Visual inspection standard	Quantitative judgment standard

Key performance indicator analysis

Fiber identification requirements

Absorbent cotton gauze needs to be verified by microscope observation (tubular structure/natural twist), iodinated zinc chloride solution (purple reaction) and zinc chloride-formic acid solution (insoluble). Blended products need to additionally distinguish between glossy/sub-glossy viscose fibers.

Physical property thresholds

Item	Gauze requirements	Gauze strip requirements
Sinking time	≤10s (16-layer sample)
Weight per square meter	13.0-72.0g/m²	33.5-44.0g/m²
Minimum breaking force	35-105N in warp direction	60N fixed in warp direction

Key points for chemical index control

• Acidity and alkalinity: methyl orange/phenolphthalein double indicator method, the solution shall not appear pink
• Soluble matter in ether: ≤0.50%, detect oil residue
• Sulfate ash: ≤0.40% for pure cotton, ≤1.20% for blended fabrics
• Loss on drying: ≤8.0% for pure cotton, ≤11.0% for blended fabrics

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Biological safety requirements

Sterilization method selection

The standard clearly does not recommend ethylene oxide sterilization (strong adsorption), and recommends other methods such as radiation sterilization. Sterile products must comply with the packaging requirements of GB/T19633.1.

Biological Burden Test

Use the membrane filtration method and determine the correction factor through the inoculation test of Bacillus atrophaeus ATCC9372. The calculation formula is:
Biological Burden = Measured Colony Count × (Inoculated Bacteria Count/Washed Recovered Bacteria Count)

Implementation Suggestions

1. Establish an inspection process for incoming fiber raw materials, focusing on monitoring the proportion of viscose blends
2. Improve the sterilization process validation documents, especially the correlation data between bioburden and sterilization parameters
3. Upgrade laboratory testing capabilities and equip with ethylene oxide residue detection equipment such as UV spectrophotometer
4. Periodically conduct methodological validation to ensure that the recovery rate is ≥50%

YY/T 0331-2024 history

• 2024 YY/T 0331-2024 Performance requirements and test methods for absorbent cotton gauze and absorbent cotton viscose blended gauze
• 2006 YY/T 0331-2006 Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

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