Recently, the Spanish Ministry of Industry and Small and Medium-sized Enterprises issued a resolution announcing that Chinese mask-related standards can replace European standards.
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-sized Enterprises recently issued a resolution announcing that Chinese mask-related standards can be replaced European standard.
According to the resolution, during the epidemic, in addition to obtaining the CE mark by complying with coordinated standards, Spain will also allow the use of protective masks that comply with Chinese standard GB2626 (protection level KN95) , but it needs to comply with the following methods:
First, with the authorization of the Ministry of Health, public procurement does not have a CE mark but complies with the Chinese standard GB2626 (protection level KN95 ) protective masks for use by medical staff;
Second, protective masks without CE marking have been verified by authorized agencies and proven to comply with Chinese standard GB2626 (protection level KN95) , and at the same time carry out the necessary procedures to obtain the CE mark, which can be temporarily sold during the epidemic;
Third, it complies with Chinese standard GB2626 (protection level KN95) and meets EU regulations The basic health and safety requirements specified in medical device regulations can obtain the CE mark.
For more information: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2020-3945
