In response to the market shortage of personal protective equipment with CE marking during the COVID-19 epidemic, the Spanish Ministry of Industry and Small and Medium Enterprises recently issued a resolution announcing that Chinese mask-related standards can replace European standards.
According to the resolution, during the epidemic, in addition to obtaining the CE mark by complying with coordinated standards, Spain will also It is allowed to use protective masks that comply with Chinese standard GB 2626 (protection level KN95), but they need to comply with the following methods:
First, with the authorization of the Spanish Ministry of Health, public Purchase protective masks without CE marking but in compliance with Chinese standard GB 2626 (protection level KN95) for use by medical staff;
Second, protective masks without CE marking have been verified by authorized agencies , proving that it complies with Chinese standard GB 2626 (protection level KN95), and at the same time carrying out the necessary procedures to obtain the CE mark, it can be temporarily sold during the epidemic;
The third is that it complies with Chinese standard GB 2626 (Protection level KN95), and meet the basic health and safety requirements stipulated in the relevant EU medical device regulations, it can obtain the CE mark.
The official website of the Dutch Healthcare and Youth Inspectorate, another European country, announced that in order to ensure an adequate supply of personal protective equipment and medical device products during the epidemic, The Dutch Ministry of Social Affairs and Employment (SZW) and the Dutch National Institute of Public Health and the Environment (RIVM) have assessed that some Chinese mask standards are equivalent to relevant European standards.
Among them, KN95, KP95 (protection level equivalent to FFP2) and KN100, KP100 in Chinese standard GB 2626-2006 “Respiratory protective equipment-Self-priming filtering anti-particulate respirator” (Protection level is equivalent to FFP3) Equivalent to the European standard EN 149:2001+A1:2009 “Requirements, inspection and marking of filter half masks for particle protection in respiratory protective devices”. If Chinese KN95 masks enter the Dutch market as medical surgical masks, GB 2626-2006 will be equivalent to the Dutch national standard NEN-EN 14683: 2019 “Requirements and Test Methods for Medical Masks”.
In response to the shortage of epidemic prevention materials, the Dutch government has unified the coordination of national protective products and mobilized various departments to supervise related products without CE marking.