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China’s current mask standards
China’s mask standards are currently divided into three categories: labor protection, medical protection and daily protection.
1.1 Labor insurance mask standard
China’s labor protection mask standard adopts GB2626-2006 “Respiratory Protective Products-Self-priming Filtering Anti-particulate Respirator”. This standard was issued by the State Administration of Work Safety on March 27, 2006. It mainly targets industrial dust masks, and specifies the technical requirements, detection methods and identification of self-priming filter anti-particulate respirators. The standard classifies masks into 90 (KN90, KP90), 95 (KN95, KP95), and 100 (KN100, KP100) grades according to the filtering efficiency of the masks. The KN series uses sodium chloride particles for detection, and the KP series uses oil particles for detection. In terms of filtration efficiency, 85L / min flow rate is used for testing. KN90 / KP90 should be ≥90.0%, KN95 / KP95 should be ≥95.0%; KN100 / KP100 should be ≥99.97%. The requirements of the respiratory impedance are: the inhalation resistance does not exceed 350pa, and the exhalation resistance does not exceed 250pa.
1.2 Standards for medical and health masks
China has two medical mask standards.
YY0469-2011 specifies the technical requirements for medical surgical masks, which are applicable to disposable masks worn by clinical medical personnel during invasive procedures. The standard BFE test flow is 28.3L / min, and the filtration efficiency requirement is ≥95%; the PFE test flow is 30L / min, and the filtration efficiency requirement is ≥30%; the respiratory resistance test flow is 8L / min, and the test area is 5.06cm2. The resistance requirement is ≤49mmH2O; there is a requirement for penetration of synthetic blood: 2mL of synthetic blood is sprayed to the mask at a pressure of 10.7KPa (80 mmHg), and there should be no penetration inside the mask.
190GB19083-2010 specifies the technical requirements, test methods, signs and instructions for use of medical protective masks, as well as packaging, transportation and storage. It is suitable for self-priming filtering medical protective masks that filter particulates in the air and block droplets, blood, body fluids, secretions, etc. in the medical work environment. The standard is tested at a flow rate of 85. The suction resistance of the mask does not exceed 343.2Pa (35 mm H2O). Synthetic blood penetration requirements: 2mL of synthetic blood is sprayed to the mask at a pressure of 10.7KPa (80 mmHg), and there should be no penetration inside the mask. Masks are classified according to filtering efficiency: filtering efficiency of level 1 ≥95%, filtering efficiency of level 2 ≥99%, and filtering efficiency of level 3 ≥99.97 .
1.3 Standards for daily protective masks
Because of different use environments and different main objects of protection, any of the first two types of masks cannot be fully applied to civil anti-fog and haze. In order to protect the health of people’s daily life, GB / T 32610-2016 “Technical Specifications for Daily Protective Masks” was released. The standard innovatively achieves a way to match the degree of air pollution in the classification of masks, so that people can selectively wear them according to the level of the mask under different levels of pollution to achieve the purpose of preventing fine particles from being inhaled.
The reform standard uses two grading methods. One is the level of protection effect that integrates indicators such as leakage rate, and the other is the classification of filtration efficiency. The protective effect is divided into A, B, C, and D grades. Filtration efficiency is divided into Ⅰ, Ⅱ, and Ⅲ grades, which are tested by salty medium and oily medium respectively. Grade Ⅰ salt / oil filtration efficiency is ≥99%, Grade Ⅱ salt / oil filtration efficiency is ≥95%, Grade Ⅲ salt filtration efficiency is ≥90% and oil filtration efficiency is ≥80%. The standard test flow is 85L / min. When the protection level of the mask reaches level A, its filtering efficiency level should be Ⅰ or Ⅱ. When the protection level of the mask is B, C, D, its filtering efficiency level should be Ⅱ or Ⅲ.
2 Current international mask standards
International mask standards are currently divided into two categories: labor protection and medical protection. Different countries have different mask standards, so only the ones with the most influence are listed here.
2.1 American Labor Protection Mask Standards: NIOSH Standards (Title 42 CFR Part 84)
标准 This standard is classified according to the different test media and filtration efficiency. The N series uses sodium chloride particles for detection, the R series uses non-oily suspended particles and sweaty suspended particles for a period of eight hours, and the R series uses protective non-oily suspended particles and sweaty suspended particles for no time limit. The standard test flow rate is 85L / min, the filtration efficiency of N95 / R95 / P95 is ≥95.0%; the filtration efficiency of N99 / R99 / P99 is ≥99.0%; the filtration efficiency of N100 / R100 / P100 is ≥99.97%. The requirements of the respiratory impedance are: the inhalation resistance does not exceed 350pa, and the exhalation resistance does not exceed 250pa.
2.2 EU labor protection mask standard EN149: 2001 + A1-2009
The standard is classified according to the filtration efficiency. Two kinds of particles are used for detection, and the test flow rate is 95L / min. The penetration rate of sodium chloride and oily particles of FFP1 are ≤20%; the penetration rate of sodium chloride and oily particles of FFP2 are ≤6%, and the penetration rate of sodium chloride and oily particles of FFP3 are ≤1%.
The standard inhalation resistance is tested at two flows. When the detection flow rate is 30L / min, the suction resistance of FFP1 is ≤0.6mbar, the suction resistance of FFP2 is ≤0.7mbar, and the suction resistance of FFP3 is ≤1.0mbar; when the detection flow rate is 95L / min, the suction resistance of FFP1 is ≤2.1 mbar, the suction resistance of FFP2 is ≤2.4mbar, and the suction resistance of FFP3 is ≤3.0mbar. The expiratory resistance is measured at a flow rate of 160L / min. The expiratory resistance of FFP1, FFP2, and FFP3 are all ≤3.0mbar.
2.3 American Medical Mask Standard ASTM F2100-2004
Low level indicators require BFE≥95%, differential pressure <4.0mmH2O, hemodialysis 80mmHg; Moderate level indicators require BFE≥98%, differential pressure <5.0mmH2O, PFE≥98%, hemodialysis 120mmHg; High The index requirements are BFE ≥98%, pressure difference <5.0mmH2O, PFE ≥98%, and hemodialysis 160mmHg.
2.4 EU Medical Mask Standard EN14683-2014
标准 The standard is classified according to filtration efficiency. The requirement of TYPE Ⅰa is BFE ≥ 95%, and the pressure difference is <29.4 Pa, a represents that this material can only be used for patients and allergic people; the specification of TYPE Ⅱ is BFE ≥ 98%, and the pressure difference is <29.4 Pa, Hemodialysis 120mmHg. The standard BFE test flow is 28.3L / min;
The differential pressure test flow is 8L / min, and the test area is 4.9cm2.