Standard for surgical masks
Testing contents and standards of medical surgical masks
With the outbreak and persistence of the epidemic, wearing masks outside the house is an effective means to prevent the spread of the virus. For a time, medical masks have become a scarce resource. Because of the scarcity, many people began to use "cotton masks" and "homemade plastic masks" instead of medical masks, thinking that as long as the nose and mouth are covered, the virus can be prevented. However, there are reference standards for the design and production of medical masks. Only when the standards are met can they be regarded as a mask that can effectively block the transmission of virus.
So, which standard do medical masks refer to? What are the corresponding test equipment?
Main test items of medical surgical masks: appearance, structure and size, nose clip, nose band, synthetic blood penetration, bacterial filtration efficiency, particle filtration efficiency, pressure difference, flame retardancy, microorganism, ethylene oxide residue, etc
Main test standard of medical surgical mask: yy0469-2011 medical surgical mask
As for the specific technical requirements and testing requirements of YY 0469-2011 medical surgical masks, we now give you the following information:
1. Appearance
The appearance of the mask shall be clean and in good shape, and the surface shall not be damaged or stained.
2. Structure and size
After wearing the mask, it should be able to cover the nose, mouth and jaw of the wearer. It shall conform to the design size and tolerance of the sign
3. Nose clip
The mask should be equipped with nose clip, which is made of plastic material
The length of nose clip should not be less than 8.0cm
4. Mask belt
The mask belt should be easy to wear and take out.
The breaking strength at the connection point between each mask belt and the mask body shall not be less than 10N.
5. Synthetic blood penetration
After 2ml synthetic blood was sprayed to the outer side of the mask at a pressure of 16.0kpa (120mmhg), there should be no penetration on the inner side of the mask.
6. Filtration efficiency
The bacterial filtration efficiency (BFE) of mask should not be less than 95%
Particle filtration efficiency (PFE) the filtration efficiency of the mask for non oily particles should not be less than 30%.
7. Breathing resistance tester for pressure difference (AP) mask
The pressure difference p between the two sides of the mask for gas exchange shall not be greater than 49pa
8. Flammability testing machine for flame retardant masks
The mask material should be nonflammable; The burning time of the mask after leaving the flame is not more than 5S
9. Microbiological index
CFU / G: ≤ 100
Coliform: not detectable
Pseudomonas aeruginosa: not detectable
Staphylococcus aureus: not detectable
Hemolytic streptococcus: not detectable
Fungi: not detectable
The mask marked with "sterilized" or "sterile" or illustrated on the package should be sterile.
10. Ethylene oxide residue
The residual amount of ethylene oxide in the sterilized mask should not exceed 10ug / g.
11. Skin irritation
The primary irritation index of mask material should not exceed 0.4.
12. Cytotoxicity
The cytotoxicity of the mask should be no more than grade 2.
13. Delayed type hypersensitivity
The mask material should have no allergic reaction.
Precautions for FDA certification of masks:
1. May include masks marked as surgical, laser, isolation, dental or medical procedure masks.
2. Can help prevent exposure to microorganisms, body fluids and large particles in the air.
3. Designed to loosely cover the mouth and nose, but not suitable for personal use.
4. It may help to prevent the patient from contacting the saliva and respiratory secretions of the wearer.
5. Have specific instructions, warnings and restrictions for use in a healthcare environment
How long can medical disposable masks be taken? Do masks have a shelf life
1. In order to give full play to the protective effect of the mask, when wearing the mask, try to tighten the elastic band of the mask and compress the aluminum sheets on both sides of the nose, so as to reduce the leakage around, and it is best to breathe slowly.
2. Wear it at the right time. The medical non-woven mask can be used continuously for 6-8h, and should be replaced in time in case of the following situations: dyspnea, damaged or damaged mask, failure to close the mask to the face, contaminated mask (such as blood stains or droplets, etc.), used in isolation ward or patient contact, with peculiar smell.
3. Never squeeze the mask with your hands after wearing it. All kinds of masks, including N95 masks, can only isolate the virus on the surface of the mask. If you squeeze the mask with your hand to make the virus wet through the mask with droplets, you still have a chance to infect the virus.
4. Do not discard the discarded masks at will, otherwise it will cause secondary pollution. The masks used in general environment should be put into dustbin, and the masks used in polluting environment should be treated as hazardous waste.
With the outbreak and persistence of the epidemic, wearing masks outside the house is an effective means to prevent the spread of the virus. For a time, medical masks have become a scarce resource. Because of the scarcity, many people began to use "cotton masks" and "homemade plastic masks" instead of medical masks, thinking that as long as the nose and mouth are covered, the virus can be prevented. However, there are reference standards for the design and production of medical masks. Only when the standards are met can they be regarded as a mask that can effectively block the transmission of virus.
So, which standard do medical masks refer to? What are the corresponding test equipment?
Main test items of medical surgical masks: appearance, structure and size, nose clip, nose band, synthetic blood penetration, bacterial filtration efficiency, particle filtration efficiency, pressure difference, flame retardancy, microorganism, ethylene oxide residue, etc
Main test standard of medical surgical mask: yy0469-2011 medical surgical mask
As for the specific technical requirements and testing requirements of YY 0469-2011 medical surgical masks, we now give you the following information:
1. Appearance
The appearance of the mask shall be clean and in good shape, and the surface shall not be damaged or stained.
2. Structure and size
After wearing the mask, it should be able to cover the nose, mouth and jaw of the wearer. It shall conform to the design size and tolerance of the sign
3. Nose clip
The mask should be equipped with nose clip, which is made of plastic material
The length of nose clip should not be less than 8.0cm
4. Mask belt
The mask belt should be easy to wear and take out.
The breaking strength at the connection point between each mask belt and the mask body shall not be less than 10N.
5. Synthetic blood penetration
After 2ml synthetic blood was sprayed to the outer side of the mask at a pressure of 16.0kpa (120mmhg), there should be no penetration on the inner side of the mask.
6. Filtration efficiency
The bacterial filtration efficiency (BFE) of mask should not be less than 95%
Particle filtration efficiency (PFE) the filtration efficiency of the mask for non oily particles should not be less than 30%.
7. Breathing resistance tester for pressure difference (AP) mask
The pressure difference p between the two sides of the mask for gas exchange shall not be greater than 49pa
8. Flammability testing machine for flame retardant masks
The mask material should be nonflammable; The burning time of the mask after leaving the flame is not more than 5S
9. Microbiological index
CFU / G: ≤ 100
Coliform: not detectable
Pseudomonas aeruginosa: not detectable
Staphylococcus aureus: not detectable
Hemolytic streptococcus: not detectable
Fungi: not detectable
The mask marked with "sterilized" or "sterile" or illustrated on the package should be sterile.
10. Ethylene oxide residue
The residual amount of ethylene oxide in the sterilized mask should not exceed 10ug / g.
11. Skin irritation
The primary irritation index of mask material should not exceed 0.4.
12. Cytotoxicity
The cytotoxicity of the mask should be no more than grade 2.
13. Delayed type hypersensitivity
The mask material should have no allergic reaction.
Precautions for FDA certification of masks:
1. May include masks marked as surgical, laser, isolation, dental or medical procedure masks.
2. Can help prevent exposure to microorganisms, body fluids and large particles in the air.
3. Designed to loosely cover the mouth and nose, but not suitable for personal use.
4. It may help to prevent the patient from contacting the saliva and respiratory secretions of the wearer.
5. Have specific instructions, warnings and restrictions for use in a healthcare environment
How long can medical disposable masks be taken? Do masks have a shelf life
1. In order to give full play to the protective effect of the mask, when wearing the mask, try to tighten the elastic band of the mask and compress the aluminum sheets on both sides of the nose, so as to reduce the leakage around, and it is best to breathe slowly.
2. Wear it at the right time. The medical non-woven mask can be used continuously for 6-8h, and should be replaced in time in case of the following situations: dyspnea, damaged or damaged mask, failure to close the mask to the face, contaminated mask (such as blood stains or droplets, etc.), used in isolation ward or patient contact, with peculiar smell.
3. Never squeeze the mask with your hands after wearing it. All kinds of masks, including N95 masks, can only isolate the virus on the surface of the mask. If you squeeze the mask with your hand to make the virus wet through the mask with droplets, you still have a chance to infect the virus.
4. Do not discard the discarded masks at will, otherwise it will cause secondary pollution. The masks used in general environment should be put into dustbin, and the masks used in polluting environment should be treated as hazardous waste.
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