Are Chinese Standard Face Masks Equivalent to European Ones?

Are Chinese Standard Face Masks Equivalent to European Ones?


Recently, the official website of the Health and Youth Care Inspectorate (IGJ) announced that, in order to ensure adequate supply of personal protective equipment and medical devices during the epidemic, Netherland's Ministry of Social Affairs and Employment (SZW) and National Institute of Public Health and Environment (RIVM) assessed that the standards of some face masks in China are equivalent to relevant European ones.
 
European Union
Among them, KN95, KP95 (protection level equivalent to FFP2) and KN100, KP100 (protection level equivalent to FFP3) in Chinese standard GB2626-2006, pursuant to "Respiratory protective equipment - particulate respirator with self-priming filter", are equivalent to European standard EN149:2001+A1:2009, according to "Requirements, Inspection and Marking of Filtering Half Mask for Particulate Protection of Respiratory Protective Devices". If Chinese KN95 masks enter the Dutch market as surgical masks, GB2626-2006 can be equivalent to Dutch national standard NEN-EN14683:2019, in terms of "Requirements and Test Methods for Medical Masks".
 
At the same time, the Spanish Ministry of Industry and SMEs issued a resolution announcing that the relevant standard
s for Chinese masks can replace European standards. According to the resolution, during the epidemic, in addition to obtaining the CE mark through compliance with the coordinated standards, Spain will also allow the use of protective masks (protective level KN95) that meet the Chinese standard - GB2626, provided that the following conditions are met:
 
First, under the authorization of the Ministry of Health, allow the public procurement of protective masks that do not have CE marks but conform to the Chinese standard GB2626 (protection level KN95) for use by medical personnel.
 
Second, protective masks without CE marks, which have been verified by authorized agencies to meet the Chinese standard GB2626 (protection level KN95), and of which necessary procedures for obtaining CE marks have been carried out, can be sold temporarily during the epidemic.
 
Third, CE marks can be obtained when in accordance with the Chinese standard GB2626 (protection level KN95) and the basic health and safety requirements specified in relevant EU regulations on medical devices.