Thai FDA has recently announced a list of standards to be complied by disposable surgical masks, upon making a set of COVID-19 related medical devices announcement. Disposable surgical masks to be registered and sold in Thailand must comply with at least one of the standards, as following:
1) TIS. 2424-2562: Single-use hygienic face masks or update standard under “Biological specification (Protective mask level 3 only) and Physical specification”.
2) ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face Masks or update standard under “Bacterial filtration efficiency, Differential pressure, Sub-micron particulate filtration efficiency at 0.1 micron, Resistance to penetration by synthetic blood and Flame spread”.
3) EN 14683:2014, Medical face masks. Requirements and test methods or update standard under “Splash resistance (Type IIR only), Bacterial filtration efficiency (BFE), Breathability and Biocompatibility”.
4) YY 0469-2011, Surgical mask or update standard under “Bacterial filtration efficiency (BFE), Particle filtration efficiency (PFE), Synthetic blood penetration, Pressure difference (∆p), Flame retardation properties, Skin irritation, Cytotoxicity and Delayed-type hypersensitization”.
5) YY/T 0969-2013, Single-use Medical Face Mask or update standard under “Bacterial filtration efficiency (BFE), Airflow resistance and Biological evaluation”.
6) Other standards which had been approved by Secretary Thai FDA General Thai FDA.
Thai FDA’s Secretary-General has the right to finalized any decision making regarding any issues arise from the announcement. This decree is implemented starting from October 12, 2020 onwards.
References:
Food and Drug Administration Announcement Regarding Standard of Disposable Surgical Mask to Comply in 2020