Before the production of the masks, we must first understand the corresponding national standards for masks. Qualified masks must meet the standard requirements, and different standards have different requirements for mask performance. This article has compiled a list of the most complete versions of domestic and international standards for masks.
Sincerely remind, before the production of masks, companies must understand mask standards for export mask use, export place/country, to avoid the creation of Unnecessary Losses. Don’t take any chances by producing to strict standards. Without further ado, go straight to the standard.
EU and USA standards for masks
The standards for masks in Europe and the United States divide masks into two categories: labor protective masks and medical protective masks. The following is a list of common standards for the introduction.
1 U.S. standard for labor masks: NIOSH Standards (Title 42 CFR Part 84)
Table 1: Levels and Requirements of NIOSH Standard Mask
|Filter element||NaCl Particle Testing||Oil Particle Testing|
Note: The test flow rate of this standard is 85L/min. The index requirement of respiratory resistance is that the inhalation resistance should not exceed 350pa and exhalation resistance should not exceed 250pa.
2 Labor masks in EU standard: EN 149: 2001+A1-2009
EN149:2001+A1 with three levels: FFP1, FFP2, and FFP3 corresponding to filter efficiencies of 80%, 94%, and 99%. Table 2: Class level requirements for masks according to EN149.
Table 2: Levels and Requirements for the mask of EN 149 Standard
|Grade||NaCl Particle Testing||Oil Particle Testing|
|Penetration %||Efficiency %||Penetration %||Efficiency %|
Note: The test flow rate for this standard is 95L/min.
*FFP is Filtering Face Piece, which meets the European standard EN149 but does not necessarily mean FFP2 level, it may be FFP1 level.
3 U.S. standards for medical masks: ASTM F2100-19
Table 3: Classes and Requirements for masks according to ASTM F2100
|Performance indicators||Protection level 1||Protection level 2||Protection level 3|
|Differential pressure mmH2O/cm²||＜5.0||＜6.0||＜6.0|
|Filtration efficiency for 0.1um particles 1%||≥95||≥98||≥98|
|Synthetic blood penetration,
minimum pressure mmHg
|flame resistance||Class 1||Class 1||Class 1|
4 EU standards for medical masks: EN14683: 2019
Table 4: Classes and Requirements for masks according to EN 14683
|Classify||Type Ⅰα||Type Ⅱ||Type ⅡR|
|Differential pressure Pa/cm²||＜40||＜40||＜40|
|Splash resistance kPa||No requirement||No requirement||≥16.0|
|Microbial cleanliness CFU/g||≤30||≤30||≤30|
Notice: TYPE I medical masks should only be used on patients and others to reduce the risk of transmission of infectious diseases, especially in epidemiological situations. TYPE I masks are not intended for use by medical personnel in operating theatres or other medical environments with similar requirements.
Note that the European standard does not distinguish between oily and non-oily and that the European standard can filter both oily and non-oily particles, but the same level of protection will also be available in different product models. The filtering rate of FFP2 is roughly the same as that of N95 in the US and KN95 in China. For European masks, the FFP2 or higher rating is used.
Chinese standards for masks
According to China’s standards for masks, masks can be divided into three categories: labor masks, medical masks, and protective masks.
1 Standards for labor masks
The standard for labor protection masks in China is GB 2626-2006: Respiratory protective equipment – Non-powered air-purify particle respirator. This product was implemented on December 1, 2006. Mainly for industrial dust masks, suitable for self-absorption filtered respiratory protection supplies for protection against particles of all kinds. It specifies the technical requirements, testing methods, and labeling of self-priming, filtered, anti-particulate respirators for respiratory protection articles.
According to the filtering efficiency of the mask, the mask is divided into three grades: 90 (KN90, KP90), 95 (KN95, KP95). 100 (KN100, KP100). The numbers indicate the size of the filtration efficiency, and the KN series is detected by sodium chloride particles, while the KP series is detected by oil particles. Specific requirements and classifications are shown in the figure below.
Table 5: Classification of face masks in GB 2626-2006
|Filter element||Face mask types|
|Disposable masks||Replaceable masks||Full masks|
Table 6: Filter Efficiency Levels and Requirements for Face Masks in GB2626-2006
|Filter element||NaCl Particle Testing||Oil Particle Testing|
Note: The test flow rate of this standard is 85L/min. The index requirement for respiratory resistance is that inhalation resistance does not exceed 350Pa and exhalation resistance does not exceed 250Pa.
2 Standards for medical masks
There are three existing standards for medical masks in China: YY/T 0969-2013 “Disposable medical masks”, YY 0469-2011 “Medical surgical mask”, GB 19083-2010 “Medical protective mask technology Requirements”. The differences in the scope of application and provisions of these three standards are as follows.
YY/T 0969-2013, disposable medical masks, is for the use of ordinary medical and nursing staff for routine masks. The standard is a recommended standard for the pharmaceutical industry, implemented on October 1, 2014, the core performance requirements for the bacterial filtration efficiency (BFE) requirement of ≥95% and an indicator for microorganisms in the mask is specified.
Table 7 Comparison of microbiological parameters for masks
|bacterium||YY/T 0969||YY 0469||GB 19083|
|Bacterial colony count CFU/g||≤100||≤100||≤200|
|Escherichia coli||not detectable||not detectable||not detectable|
|Pseudomonas aeruginosa||not detectable||not detectable||not detectable|
|staphylococcus aureus||not detectable||not detectable||not detectable|
|hemolytic streptococcus||not detectable||not detectable||not detectable|
|fungi||not detectable||not detectable||≤100|
YY 0469-2011, medical surgical masks, the standard specifies the technical requirements, test methods, marking and instructions for use and packaging, transport, and storage. The standard specifies the BFE requirements of the mask and YY/T 0969, increased PFE (≥30%), and synthetic blood penetration performance requirements for better protection in the case of surgical blood contact with the mask, the main performance requirements of the standard is shown in the figure below.
Table 8: Main performance requirements for masks in YY0469-2011
|BFE (%)||PFE (%)||Differential pressure (Pa)||Synthetic blood penetration|
|≥95||≥30||≥49||After the synthetic blood is sprayed at a pressure of 16.0kPa (120mmHg) onto the outer side of the mask, there should be no penetration on the inside of the mask.|
GB 19083-2010, Medical protective masks, implemented on August 1, 2011. The standard specifies the technical requirements, test methods, marking and instructions for use and packaging, transport and storage for medical protective masks, which suitable for use in medical work environments to filter particles from the air and block droplets, blood, body fluids and secretions.
Table 9: GB19083-2010 Filter Efficiency Levels and Requirements for Masks
|Grade||Filtration efficiency (%)|
Note: The test flow rate for this standard is (85±2)L/min and the inspiratory resistance of the mask does not exceed 343.2Pa (35mmH20). Synthetic blood penetration requirements: spray 2mL of synthetic blood into the mask at 10.7KPa (80mmHg), there should be no penetration on the inside of the mask.
3 Standards for protective masks
GB/T 32610-2016, the first standard for civilian protective masks of China, was implemented on Nov 1, 2016. The standard covers mask raw material requirements, structural requirements, labeling and marking requirements, appearance requirements, etc., and the main indicators include functional indicators Particle filtration efficiency, exhalation and inhalation resistance index, airtightness index and so on.
GB 32610 standard requires masks should be able to safely and securely protect the nose and mouth, there should be no accessible sharp corners and sharp edges, formaldehyde, dyes, microorganisms and other factors that may cause harm to the human body to make detailed provisions to ensure the safety of the public when wearing protective masks.
Table 10: GB/T 32610-2016 Filter Efficiency Levels and Requirements for Masks
|Filtration Efficiency Level||Level Ⅰ||Level Ⅱ||Level Ⅲ|
|filtration efficiency (%)||Saline||99||95||90|
Table 11: GB/T 32610-2016 Requirements for the protective effect of masks
|Protective effect class||Class A||Class B||Class C||Class D|
|Protective effect (%)||≥90||≥85||≥75||≥65|
Table 12: GB/T 32610-2016 Ambient air quality for masks
|Filtration Efficiency Class||Class A||Class B||Class C||Class D|
|Applicable air environment||Serious pollution||Serious pollution and below||Severely pollution and below||Moderate pollution and below|
|Applicable PM2.5 values (ug/m³)||500||350||250||150|
|PM2.5 limit valve (ug/m³)||700||500||300||200|
Note: The test flow rate of this standard is 85L/min. when the protection level of the mask reaches Class A, its filtration efficiency level should be Level Ⅰor Level Ⅱ. When the mask’s protection class is B, C, or D, its filtration efficiency should be Level Ⅱ or Level Ⅲ.
In addition to national standards, there are also some group standards, and the current group standards and contents are as follows.
“PM2.5 Protective Masks” a group standard proposed and developed by the China Textile Business Association and implemented on March 1, 2016. The standard was developed for haze protection.
“General protective masks” by the China Textile Business Association proposed the development of group standards, implemented on 30 January 2020, applicable to daily life to filter pollen, willow wool, bacterial particles and block nasal or oral exhalation or ejection of pollutants to wear protective masks.
T/CNTAC 55-2020, T/CNTIA 09104-2020
“The Civil Hygiene Mask”, a group standard jointly proposed by the China Textile Industry Federation and the China Industrial Textiles Association, was implemented on March 11, 2020, which is applicable to the general population in the daily environment for blocking the spread of droplets, pollen, microorganisms, and other particles.
Japanese and Korean mask standards
1 Japan DS2
Japanese mask standard “DS2” is a national standard of the Japanese Ministry of Labor, which is equivalent to the Chinese standard “KN95” and the American standard “N95”. Printed on the package: ウィルスカット99% (virus blocking 99%), which refers to the efficiency of the filter exceeds the domestic standard of 99%. Medical masks.
2 Korea KF series
Korean Ministry of Food and Drug Safety (the mainstream Korean standard for masks issued by Korea’s Food and Drug Administration). KF series are divided into KF 80, KF 94, KF 99.
|Series||filtration efficiency||leakage rate||resistance|
Finally, a brief summary in one paragraph is as follows.
The N series of masks is the American standard, the KN series is the Chinese standard, and the FFP series is the European standard. The latter number refers to the protection capacity, the higher the level of protection. KN95 refers to the ability to filter out more than 95% of non-oily particles, and the protection is roughly equivalent to that of the European standard mask FFP2. It is expressed by a formula: FFP3>FFP2=N95=KN95>KN90. Generally, it is used to resist Viruses and flu, the N95 series is adequate, and the 90 series is also 90% resistant.
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