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The Difference of Surgical Mask Between ASTM F2100 Level 1, Level 2 and Level 3

When we buy surgical masks of ASTM F2100 level 1, 2, or 3, do you notice the words of the executive standard on them? A safe and qualified surgical mask product must have an executive standard, and today we bring you the relevant content of the surgical mask of ASTM F2100 level 1, level 2, and level 3.

This article covers three main areas:

  • What is a surgical mask for the ASTM F2100 level 1, level 2, and level 3?
  • What are the performance requirements for ASTM F2100 level 1, level 2, and level 3 surgical masks?
  • How to use different levels of surgical masks of ASTM F2100 level 1, level 2, and level 3?

 

What is a surgical mask of the ASTM F2100 level 1, level 2, and level 3?

The ASTM F2100 standard is a medical standard that classifies masks into three levels: low protection (Level 1), medium protection (Level 2), and high protection (Level 3). The higher the level, the better the protection performance.

ASTM F2100 level 1 and level 2 masks are usually called procedure masks; while ASTM F2100 level 3 masks can be used in the operating room and are also called surgical masks. Wearing a surgical mask of ASTM F2100 level 1, level 2, and level 3 not only prevents the spread of bacteria to the patient through the mouth and nose but also protects you from infection. The higher the risk, the higher the level of protection mask should be chosen.

protective clothing and mask

Compared to non-level masks such as homemade cotton masks, the ASTM F2100 level 1, level 2, and level 3 masks will provide better protection against aerosols emitted by the wearer, thereby reducing the spread of disease. Protective clothing worn by medical personnel is used for similar purposes as masks and can effectively protect health care workers and patients from the accidental spread of disease.

 

What are the performance requirements for ASTM F2100 level 1, level 2, and level 3 surgical masks?

ASTM F2100 is the current standard for medical masks in the U.S. and can be registered by the FDA. FDA is the abbreviation of Food and Drug Administration, one of the executive agencies of the U.S. government in the Department of PHS (Public Health Service) under the DHHS (Department of Health and Human Services). FDA mask certification basically follows the ASTM F2100 standard.

FDA mask certification requires the ASTM F2100 level 1, 2, and 3 surgical masks to meet relevant standards in four areas: bacterial filtration efficiency (BFE), particle filtration efficiency (PFE), and synthetic blood penetration resistance, and differential pressure.

ASTM F2100 level 1 mask can block 95% of bacteria and particles, even if only ASTM F2100 level 1 protection is achieved, it is sufficient for general protection. ASTM F2100 level 2 and level 3 require masks that block at least 98% of bacteria and particles, with a differential pressure of just under 6.0mm H2O/cm2 (49.03 Pa/cm2), which is a little more lenient than the lower protection level, because it is harder to maintain breathability while achieving better protection.

The main difference between ASTM F2100 level 2 masks and level 3 masks is that level 3 (high protection standard) has higher requirements for synthetic blood penetration resistance. For example, medical N95 masks need to meet both the Surgical Masks-Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff standards, as well as the NIOSH requirements for N95 masks, which require testing for Synthetic blood penetration and surface moisture resistance.

For ASTM F2100 level 1, level 2, and level 3 masks, the ASTM F2100 standard specifies the test methods for mask performance.

  • Bacterial Filtration Efficiency ASTM F2101
  • Particulate Filtration Efficiency ASTM F2299/F2299M
  • Synthetic Blood Penetration Resistance ASTM F1862/F1862M
  • Differential Pressure EN14683 Annex C
  • Flammability 16 CFR 1610

The specific requirements of ASTM F2100 level 1, level 2, and level 3 are shown in the following table.

Characteristic ASTM F2100 level 1 barrier ASTM F2100 level 2 Barrier ASTM F2100 level 3 Barrier
BFE (%) ≥95 ≥98 ≥98
Differential Pressure

(mm H2O/cm2)

<5.0 <6.0 <6.0
PFE at 0.1 microns (%) ≥95 ≥98 ≥98
Synthetic Blood Penetration Resistance (minimum pressure in mm Hg for pass result) 80 120 160
Flame spread Class 1 Class 1 Class 1

Bacterial Filtration Efficiency ASTM F2101

Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

The standard specifies a test method for evaluating the bacterial filtration effectiveness of medical face mask materials. The test method is to attach Staphylococcus aureus to droplets with an average particle size of 3µm and a size of 0.65 to 9µm and above, using the ratio of the number of bacteria that can penetrate the mask to the total number of bacteria attached to the aerosol to determine the filtration efficiency of the medical face mask material.

This standard is important for assessing the ability of the mask to block aerosol droplets (droplets caused by talking, coughing, and sneezing) from entering the wearer’s mouth and nose.

Particulate Filtration Efficiency ASTM F2299/F2299M

Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

The test method, which measures the filtration efficiency of medical face mask materials for submicron particles, has recently received significant attention in the media worldwide. According to the U.S. FDA, medical face masks are very effective in protecting against small particles of 0.1µm in size generated during medical procedures.

Synthetic Blood Penetration Resistance ASTM F1862/F1862M

Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

Medical face masks are intended to resist fluid penetration based on many different factors, including the surface tension and viscosity of the fluid itself, as well as the structure and relative hydrophilicity of the material, all of which need to be considered when designing a medical face mask. The standard is particularly applicable to synthetic blood penetration resistance testing and is designed to simulate the reality of using a face mask to determine if a medical face mask can effectively protect surgeons from blood splatter.

Differential Pressure EN14683 Annex C

Method for determination of breathability (differential pressure)

Daily protective masks may need to be worn for a long time, so it is necessary to have a high ventilation capacity to ensure smooth breathing, and the differential pressure is a measure of the comfort of breathing while wearing the mask.

ASTM F2100 standard has clear provisions for the differential pressure of the face mask, ASTM F2100 level 2 and level 3 face mask differential pressure ≤6.0mmH2O/cm2 (58.84Pa), ASTM F2100 level 1 face mask differential pressure ≤5.0mmH2O/cm2 (49.03Pa).

Note: The better the filtration performance, the greater the differential pressure, and the more difficult it is to breathe, such as N95 medical face masks, in order to ensure safety, the filtration effectiveness is very high, but the differential pressure is generally around 300Pa, which is not suitable for a long time daily wear.

Flammability 16 CFR 1610

Test Standard for the Flammability of Clothing Textiles

FDA surgical mask certification is a reference to the ASTM F2100 standard, and there are no requirements for flammability. FDA mask certification requires ASTM F2100 level 1, level 2, and level 3 masks to meet relevant standards in four parts: bacterial filtration efficiency, particle filtration efficiency, synthetic blood penetration resistance, and differential pressure.

 

How to use the surgical masks of ASTM F2100 level 1, level 2, and level 3?

In the years just past 2020 and 2021, the COVID-19 has appeared in almost every corner of the world and humans have been forced to take a simple and effective safety precaution: wearing a mask.

However, what many people do not know is that there are many surgical masks on the market that offer little to no protection, so it is essential to properly select the surgical mask of ASTM F2100 level 1, level 2, and level 3.

How do I know the ASTM F2100 level 1, level 2, and level 3 of a mask?

When purchasing a surgical mask, look at the box to find information regarding the ASTM F2100 level 1, level 2, and level 3, fluid resistance, or other performance metrics similar to the ASTM F2100 Standards mentioned before.

When purchasing a surgical mask, check the box to find information about the ASTM F2100 level 1, level 2, and level 3, fluid resistance, or other performance indicators similar to the ASTM f2100 standard mentioned before. If these details are not mentioned, the mask is probably not-level and does not provide adequate protection.

ASTM F2100 level 1, level 2, and level 3, which surgical mask should I buy?

There are three levels of ASTM F2100 surgical masks, which may make it difficult to know what to choose. Fortunately, even the ASTM F2100 level 1 mask can provide a degree of protection if they are for the COVID-19, ensuring no cross-contamination and effectively stopping the spread of the disease.

Therefore, when you keep a proper distance from other people and there is no high risk of exposure to the virus or exposure to other people, an ASTM F2100 Level 1 mask is sufficient. This ASTM F2100 level 1 mask provides optimal breathability at all levels, making it an ideal everyday mask.

If you are exposed to COVID-19, or more importantly if you have been infected, comfort and breathability are not primary considerations in this case and safety should be the primary concern it is recommended that ASTM F2100 level 2 or level 3 masks be worn when possible.

In short, if you are not experiencing symptoms and are not at high risk of transmitting the virus, using an ASTM F2100 level 1 mask is sufficient. When you believe you are infected, have a high risk of transmission, or are in a high-risk occupation, such as medical personnel, you should wear an ASTM F2100 level 2, or level 3 mask.

It is worth noting that even ASTM F2100 level 3 masks do not provide the wearer with perfect protection from infection. For this reason, it is necessary for you to purchase some N95 masks just in case.

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