In the case of respirators, there are various standards that these Face mask masks must meet in order to ensure the greatest possible protection of the wearer in a desired application. These mask standards vary from country to country. Many of the respirator standards are very similar in some respects and also differ in the tests or partial tests used in the mask tests or the tests of the masks. Respirators must always be examined by an accredited testing institute before these masks receive the respective approval of the country. The actual physical testing of the mask is followed by a few additional test steps. Here, for example, the manufacturing process of the respirators and also the quality assurance of the company are checked and ensured. These masks are described below and then also presented in a table on the different requirements in the area of labeling, requirement and testing of respirators. The reliable FFP2 as well as the FFP3 are not sterile medical respirators. Unfortunately, this is very often confused or misunderstood, as these masks are especially available to medical staff in the current time and must also be used by this professional group due to the high protective effect. FFP2 and FFP3 masks offer the wearer the highest possible protection against particles in the air, as well as protection against the dangerous aerosols in the ambient air. FFP2 as well as the FFP3 respirators offer the best possible protection for the actual mask wearer, as well as for the environment of the mask wearer. Important for the current COVID-19 situation and the fight against the pandemic is the use of the right respirator. For example, it is of great importance that you do not use any respirators with a valve when it comes to corona respiratory protection. Because these valves incorporated into the masks allow your exhaled breathing air to flow back or out of the room air unfiltered and thus also viruses burdened! For protective measures that are not related to the protection against Covid-19, the masks with valve are no problem and can be worn without problem depending on the desired protective effect or application.
In Europe , the standards EN 136 for full face masks, EN 140 for half masks and EN 149 with filtering half masks apply, which reflect the different protection classes FFP1 , FFP2 and FFP3 . For the German area, this is followed by the standards of the association DIN (Deutsches Institut für Normung) DIN EN 149:2001-10 and DIN EN 14683:2019. In addition, the Federal Institute for Occupational Safety and Health (BAuA) explains the various standards very well. FFP2FFP3Certified standardFFP2 (EN 149:2001+A1:2009)FFP3 (EN 149:2001+ A1:2009)Required markingManufacturer logo CE marking Year of publication of the standard Filter designation (FFP2)Manufacturer logo CE marking Year of publication of the standard Filter designation (FFP3)Further requirementsmust be a close-fitting respirator (fit test). Must have two carrying straps, preferably headbands.Documents to be provided by manufacturers and suppliers upon requestCertification according to valid standard EN 149-Manufacturer-issued certificate of conformity stating that the product meets all quality testsCertification according to valid standard EN 149-Manufacturer-issued certificate of conformity stating that the product meets all quality tests
In China, there is the KN95 standard ( China GB2626-2006) valid until June 2020, then this standard will be replaced or replaced by the GB 2626 -2019 standard. Prepared by the Standardization Administration of the People’s Republic of China (SAC). The Chinese mask type KN95 essentially meets the requirements of the US respirator N95. A KN95 mask according to test principle GB2626-2020 has a filter performance of about 95%. The FFP2 mask is here a filter value of 92% in its maximum efficiency. The KN95 offers the wearer reliable protection against corona viruses or Covid-19 virus. Therefore, the Chinese KN95 mask was allowed to be imported to Germany over a certain period of time and because of the prevailing mask shortage. However, these masks should undergo a special test via a CPA rapid test if the respirator does not have certificates from an approved test institute. In principle, these KN95 masks could only be put into circulation via the market surveillance or market supervisory authorities, the federal government or the federal state. Here was also the requirement that these KN95 could only be given to medical personnel and special professional groups. The assessment of the conformity of corona sars-Cov-2 pandemic respiratory protection (CPA) according to the testing principle for corona sars-cov-2 pandemic respiratory protection masks revision 1 was carried out according to the testing principle for corona sars-cov-2 pandemic respiratory protection masks revision 1. This CPA exam was carried out by selected test institutes.
In the United States of America (USA) there is the standard N95 (United States NIOSH-42CFR84) which is specified by the “National Institute for Occupational Safety and Health (NI-OSH, USA)“.
In Australia and New Zealand, the standards organizations Standards Australia and Standards New Zealand deal with the requirements for medical respirators, there is the standard P2 (Australia/New Zealand AS/NZA 1716:2012). The Australian standard P2 essentially meets the requirements for FFP2 masks.
Japan announces its standard through the Japan International Center for Occupational Safety and Health and announces Japan’s current standard with its standard DS (Japan JMHLW-Notification 214, 2018). The Japanese standard DS2 essentially corresponds to the N95 standard of the USA.
In Canada , the Canadian Standards Association (CSA) has published the Z94.4-11 Selection, Use and Care of Respirators standard, but NIOSH certified masks of the USA type N95 are also accepted, these standards can be found at the Canadian Centre for Occupational Health and Safety.
In Korea, the Ministry of Employment and Labor (CEEC) is responsible for personal protective equipment and sets the essential standards for the use and import of respirators with the Korea KMOEL – 2017-64 and the KOSHA GUIDE H-82-2015. This standard KMOEL – 2017-64 has been adapted by the CEEC from the old European respirator standards (EN 149:2001) and American standards and, according to the Journal of Aerosol and Air Quality Research 14, is therefore identical to masks of the old European standard EN149:2001.
Since the CEEC refers to the old standards EN 149:2001, there are no tests for KF80, KF94, KF95 and KF99 masks and no designation for reusable (R) or to be disposed of after a single use (NR). Therefore, for your safety, you should dispose of the KF80, KF94, KF95 and KF99 masks after a single use. In addition, no imprint of the standard on the mask is required. The abbreviation KF stands for Korean Filter, the number behind it for the filter performance, so a KF95 is a Korean respirator with a 95 percent filter performance.
The CEEC uses the following designations:
- Korea Second Class (KF80 masks) comply with FFP1 masks of the old standard EN 149:2001
- Korea First Class or Korea 1st Class (KF94) for FFP2 masks of the old standard EN 149:2001
- and Korea Special Class (KF95 masks or KF99 masks) for FFP3 masks of the old standard EN 149:2001
Important to know about KF80, KF94, KF95 and KF99 masks is:
- There is no designation and testing for reusability – i.e. dispose of masks after a single use
- There is no need to print the standard on the masks themselves – scammers have an easy game! Buy KF80, KF94, KF95 and KF99 masks only in their original packaging. Also pay attention to opening marks on the original packaging.
More on German on Korean standards can be found at the Korean-German Chamber of Commerce and Industry.