01 

Basic Standards

02 

Product standards

Medical masks

YY/T0969-2013 "Disposable Medical Masks".

Appearance, structure and size, nose clips, mask straps, bacterial filtration efficiency (BFE), ventilation resistance, microbial indicators, ethylene oxide residue, cytotoxicity, skin irritation, delayed hypersensitivity reactions

◎ Bacterial filtration efficiency:

Bacterial filtration efficiency of masks: not less than 95%

◎ Resistance to ventilation:

The resistance to ventilation for gas exchange on both sides of the mask should not be greater than 49 Pa/cm2

◎ Microorganisms:

Total bacterial colonies: ≤100 CFU/g

Coliforms, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococcus, and fungi should not be detected

◎ Ethylene oxide residue:

If the mask is sterilized or sterilized with ethylene oxide, the residual amount of ethylene oxide should not exceed 10 μg/g

YY0469-2011

Appearance, structure and size, nose clips, mask straps, synthetic blood penetration, filtration efficiency (bacteria, particles), pressure difference, flame retardant properties, microorganisms, ethylene oxide residue, cytotoxicity, skin irritation, delayed hypersensitivity

◎ Filtration efficiency:

Bacterial Filtration Efficiency (BFE): not less than 95%

Particulate Filtration Efficiency (PFE): The filtration efficiency of non-oily particles should not be less than 30%

◎ Synthetic Blood Penetration:

2mL of synthetic blood is sprayed at 16.0 kPa (120 mmHg) pressure onto the outside of the mask, and the inside of the mask should not be penetrated

◎ Pressure difference:

The pressure difference between the two sides of the mask for gas exchange should not be greater than 49 Pa

◎ Microorganisms:

Total bacterial colonies: ≤100 CFU/g

Coliforms, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococcus, and fungi should not be detected

◎ Ethylene oxide residue:

If the mask is sterilized or sterilized with ethylene oxide, the residual amount of ethylene oxide should not exceed 10 μg/g

GB19083-2010 Technical Requirements for Medical Protective Masks

Basic requirements for masks (appearance), nose clips, mask straps, filtration efficiency, airflow resistance, synthetic blood penetration, surface moisture resistance, microorganisms, ethylene oxide residue, flame retardant performance, tightness, skin irritation

◎ Filtration efficiency:

Level 1≥ 95%;

Level 2≥99%;

Level 3≥ 99.97%;

◎ Airflow resistance:

When the gas flow rate is 85L/min, the inhalation resistance of the mask shall not exceed 343.2Pa (35mm H2O)

◎ Synthetic Blood Penetration:

2mL of synthetic blood is sprayed at 10.7 kPa (80 mmHg) pressure into the mask, and there should be no penetration on the inside of the mask

◎ Microorganisms:

Total bacterial colony: ≤200 CFU/g

Total fungal colonies: ≤100 CFU/g

Coliforms, Pseudomonas aeruginosa, Staphylococcus aureus, and hemolytic streptococci should not be detected

◎ Ethylene oxide residue:

If the mask is sterilized or sterilized with ethylene oxide, the residual amount of ethylene oxide should not exceed 10 μg/g

◎ Flame retardant performance:

The materials used should not be flammable

The re-ignition time should not exceed 5s

Industrial Protective Masks

GB2626-2006

Appearance, filtration efficiency, expiratory valve, breathing resistance, dead space, field of view, headband, attachments and attachment parts, flammability, identification, leakage, lenses, air tightness

◎ Filtration efficiency:

KN filter elements (non-oily particulate matter):

KN90≥90.0%；

KN95≥95.0%；

KN100≥99.97%；

KP Filter Elements (Oily Particulates):

KP90≥90.0%；

KP95≥95.0%；

KP100≥99.97%；

◎ Breathing resistance:

The total inspiratory resistance of each sample should not be greater than 350Pa

The total expiratory resistance of each sample should not be greater than 250 Pa

Civilian masks

GB/T32610-2016

Appearance, color fastness to rubbing (dry/wet), formaldehyde content, pH value, decomposable carcinogenic aromatic amine dyes, ethylene oxide residue, inhalation resistance, exhalation resistance, fracture strength of the mask strap and the connection between the mask strap and the mask body, fastness of the exhalation valve cover, microorganisms, filtration efficiency, protective effect, and the field of vision under the mask

◎ Inspiratory resistance≤ 175Pa

◎ Expiratory resistance≤ 145Pa

◎ Filtration efficiency of saline media:

Class I≥ 99%, Class II≥95%, Class III.≥90%

◎ Filtration efficiency of oily media:

Class I≥ 99%, Class II≥95%, Class III.≥90%

◎ Protection effect:

Class A: Filtration efficiency above level II

Class B, Class C, Class D: Filtration efficiency above level III

◎ Microbial indicators:

The total number of fungal colonies ≤ 100 CFU/g

The total number of bacterial colonies ≤ 200 CFU/g

Coliform bacteria and pathogenic pyogenic bacteria (Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococcus) should not be detected

◎ Ethylene oxide residue:

If the mask is sterilized or sterilized with ethylene oxide, the residual amount of ethylene oxide should not exceed 10 μg/g

FZ/T73049-2014 "Knitted Mask".

pH value, formaldehyde content, logo, peculiar smell, decomposable carcinogenic aromatic amine dyes, fiber composition, color fastness (soaping resistance, water resistance, saliva resistance, friction resistance, perspiration resistance), air permeability, appearance quality + specification size

◎ Air permeability≥ 250mm/s