Key Points of Industry Standards for Medical Dressings (YY/T 0330 Medical Absorbent Cotton / YY/T 0331 Medical Absorbent Gauze / YY 0594 Surgical Gauze Dressing)

YY/T 0330-2015 Medical Absorbent Cotton

Numbered YY/T 0330-2015, this is a recommended pharmaceutical industry standard under the jurisdiction of the National Medical Products Administration, issued on March 2, 2015 and implemented on January 1, 2016, replacing YY 0330-2002. It applies to absorbent cotton made from the mature seed fibers of cotton plants, processed by removing impurities, degreasing, and bleaching, and containing no coloring additives, mainly used as a dressing in clinical hospital settings.

YY/T 0331-2006 Absorbent Cotton Gauze and Blended Gauze

The full title is Performance Requirements and Test Methods for Absorbent Cotton Gauze and Absorbent Cotton/Viscose Blended Gauze, numbered YY/T 0331-2006, issued by the State Food and Drug Administration on April 19, 2006 and implemented on April 1, 2007, replacing YY 0331-2002. The administering organization is the Jinan Medical Device Quality Supervision and Inspection Center. It specifies the performance requirements and test methods for medical absorbent cotton gauze and absorbent cotton/viscose blended gauze.

YY 0594-2006 Surgical Gauze Dressing

The full title is General Requirements for Surgical Gauze Dressing, numbered YY 0594-2006, a pharmaceutical industry standard (mandatory) issued by the State Food and Drug Administration in 2006. It specifies the general requirements as well as the packaging and labeling requirements for surgical gauze dressing made from absorbent cotton gauze or absorbent cotton/viscose blended gauze; the products may be supplied either sterile or non-sterile.

Regulatory Classification and Registration Requirements

All three categories of products above fall within the scope of medical device administration and may be manufactured and sold only after obtaining a registration certificate or completing filing in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Registration and Filing of Medical Devices. Manufacturing enterprises must establish a quality management system and pass the corresponding audits.

Source: National Public Service Platform for Standards Information (State Administration for Market Regulation), YY/T 0330-2015, https://std.samr.gov.cn/hb/search/stdHBDetailed?id=F9976B450FCC0E9CE05397BE0A0A3BF6; YY/T 0331-2006, https://std.samr.gov.cn/hb/search/stdHBDetailed?id=8B1827F1EA30BB19E05397BE0A0AB44A