There are different standards for medical respirators, depending on your country. These are listed below before you can find clear tables of the different requirements for labeling and testing of the respirators in the standards.
In Europe, the standards EN 133 apply, which divides the various respiratory protection devices into those that are dependent on the ambient air (filter devices) and those that are independent of the ambient air (insulating devices). The European standard EN 136 is concerned with full face masks, EN 140 with half masks and EN 149 with filtering half masks, in which the protective classes FFP1, FFP2 and FFP3 are found. For the German area the standards of the association DIN (Deutsches Institut für Normung) DIN EN 149:2001-10 and DIN EN 14683:2019 follow. In addition, the Federal Institute for Occupational Safety and Health (BAuA) explains the various standards very well.
In China, the standard KN95 (China GB2626-2006) exists until June 2020, when it will be replaced by GB 2626 -2019. This standard is created by the Standardization Administration of the People's Republic of China (SAC). The Chinese mask type KN95 essentially corresponds to the requirements of the U.S. N95 respirator masks.
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 specifications for medical respiratory masks, there is the standard P2 (Australia/New Zealand AS/NZA 1716:2012). The Australian P2 standard essentially meets the requirements for FFP2 masks.
Japan announces its standard through the Japan International Center for Occupational Safety and Health and with its standard DS (Japan JMHLW-Notification 214, 2018) announces Japan's current standard. The Japanese DS2 standard is essentially the same as the US N95 standard.
In Canada, the standards organization Canadian Standards Association (CSA) has published the standard Z94.4-11 Selection, Use and Care of Respirators, 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, with Korea 1st class (Korea KMOEL - 2017-64), sets the essential standards for the use and import of respiratory masks. We do not explain them here, but you can find more information on Korean standards at the Korean-German Chamber of Commerce and Industry.
|Description||NIOSH N95 (42 CFR Part 84||FFP2 (EN 149:2001)||KN95 (GB2626-2006)|
|Necessary labelling||manufacturer name TC-84A-#### NIOSH lot number filter designation (N95) model number||manufacturer logo, CE-labelling, year of publication of the norm, filter name (FFP2)||number and year of the norm (year of publication), filter name (KN95)|
|Additional requirements||Must be a tight-fitting respiratory mask (fit test) and must have two carrying straps, preferably head straps|
|Documents that manufacturers and suppliers should make available on request||a certificate issued by the manufacturer stating that the product has passed all quality tests||Certification according to the valid standard EN 149 - a certificate of conformity issued by the manufacturer stating that the product meets all quality tests||Valid GB2626-2006 product identification certificate. Certificate issued by the manufacturer stating that the product has passed all quality tests mask test data|
The following requirements apply to the Chinese standard KN95 (China GB2626-2006), the European standard FFP2 (EN 149-2001) and the US standard N95 (NIOSH-42C FR84)
|Certificate/ class (standard)||N95 (NIOSH-42C FR84)||FFP2 (EN 149-2001)||KN95 (GB2626-20 06)|
|Minimal efficency||≥ 95%||≥ 92%||≥ 95%|
|Test substance||NaCl||NaCl und Paraffin oil||NaCl|
|Flow rate||85 L/min||95 L/min||85 L/min|
|Total internal leakage (TIL) under pressure of a human test object||Nicht verfügbar||≤ 8% leakage (arithmetic mean value)||≤ 8% arithmetic mean value )|
|Resistance during inhalation - maximum pressure drop||≤ 343 Pa||≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min) ≤ 500 Pa (Constipation)||≤ 350 Pa|
|Flow rate||85 L/min||≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min) ≤ 500 Pa (Constipation)||85 L/min|
|Resistance during exhalation - maximum pressure drop||≤ 245 Pa||≤ 300 Pa||≤ 250 Pa|
|Flow rate||85 L/min||160 L/min||85 L/min|
|Requirements during exhalation for valve leakage||Leakage rate≤ 30 mL/min||Not available||Pressure reduction until 0 Pa ≥ 20 sec|
|Applied force||-245 Pa||Not available||-1180 Pa|
|CO2 clean-up||Not available||≤ 1%||≤ 1%|
For U.S. respirators, the Centers for Disease Control and Prevention with The National Personal Protective Technology Laboratory (NPPTL) provides an overview of the final 42 CFR Part 84 Respiratory Protective Devices, the new particulate filter tests can be found, as well as the following table, from the Centers for Disease Control and Prevention.
|Filter Designation||Minimum Efficiency||Test Agent||Maximum Test Challenge Loading|
|N100||99.97%||NaCl||200 mg filter loading|
|N99||99%||NaCl||200 mg filter loading|
|N95||95%||NaCl||200 mg filter loading|
|R100||99.97%||DOP||200 mg filter loading|
|R99||99%||DOP||200 mg filter loading|
|R95||95%||DOP||200 mg filter loading|
|P100||99.97%||DOP||Maximum filter degradation|
|P99||99%||DOP||Maximum filter degradation|
|P95||95%||DOP||Maximum filter degradation|
All information without guarantee, even if it has been compiled to the best of our knowledge and belief by the various certification bodies.
We hope we have been able to provide you with valuable information about medical respirators.