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Spain and the Netherlands have successively announced that Chinese mask standards can replace Europe

  • Release on:2020-06-05
In response to the current shortage of the CE-marked personal protective equipment market during the New Coronary Pneumonia epidemic, the Spanish Ministry of Industry and SMEs 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 through compliance with the harmonized standards, Spain will also allow the use of protective masks(Nose Mask Wholesale) that comply with the Chinese standard GB 2626-2006 (protection level KN95), but need to comply with the following methods:

First, when authorized by the Spanish Ministry of Health, publicly purchased protective masks without CE mark but in accordance with Chinese standard GB 2626-2006 (protection level KN95) for use by medical personnel;

The second is that the protective masks(Earloop Face Mask On Sales) without CE mark have been verified by the authorized institution and proved to meet the Chinese standard GB 2626 (protection level KN95). At the same time, the necessary procedures for obtaining the CE mark are carried out, and they can be temporarily sold during the epidemic;

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The third is to meet the Chinese standard GB 2626 (protection level KN95), and meet the basic health and safety requirements stipulated in the relevant medical device regulations of the European Union, and obtain the CE mark.

Another European country's official website for the Dutch Health Care(Earloop Face Mask On Sales) and Youth Inspection Agency announced that in order to ensure the adequate supply of personal protective equipment and medical device products during the outbreak, the Dutch Ministry of Social Affairs and Employment (SZW) and the Dutch National Institute of Public Health and Environment ( RIVM) assessment, some Chinese mask standards are equivalent to related European standards.

Among them, KN95, KP95 (protection level equivalent to FFP2) and KN100, KP100 (protection level equivalent to FFP3) and European standard EN 149 in Chinese standard GB 2626-2006 "Respiratory protective equipment-Self-priming filter anti-particulate respirator" 2001+A1:2009 "Requirements, inspection and marking of filtering half masks for particle protection of respiratory protective devices" is equivalent. If Chinese KN95 masks enter the Dutch market as medical surgical masks, GB 2626-2006 is equivalent to the Dutch national standard NEN-EN 14683:2019 "Requirements and Test Methods for Medical Masks".

In response to the shortage of anti-epidemic materials, the Dutch government coordinated national protection products and mobilized various departments to supervise products without CE marking.