CHOOSING RIGHT MASK
Things to know.
When was the last time you were struck in the face by blood or other bodily fluids during surgery? Studies1 show such incidents occur to OR staff, on average, between 45% and 51% of the time, and that’s an excellent reason to be sure you’re wearing a face mask that provides the protection you need. But with all the options available, knowing how to select the mask that will give you the right level of protection for the task at hand can be confusing. Fortunately, that process has been made as easy as 1-2-3 with ASTM ratings.
What is ASTM? – ASTM International is a global organization that develops and publishes technical standards for an expansive array of products, materials, systems and services. Today, more than 12,800 ASTM standards are in use around the world, including ASTM F2100-11, the standard for medical face masks since 2012.
Where does the Easy as 1 – 2 – 3 come in? – In developing ASTM F2100-11, the organization tested material used to make medical face masks on five performance metrics. Based on their test scores, ASTM assigns a numerical rating for the barrier performance of the material:
- Level 1 – for low risk of fluid exposure
- Level 2 – for moderate risk of fluid exposure
- Level 3 – for high risk of fluid exposure
So, how will I know how each mask is rated? Simply look for ASTM Level 1, 2, or 3 on the face mask package. However, not all face masks are ASTM-rated, so it’s important to check before you choose. It’s worth the effort to find face masks that DO carry the ASTM rating, to be sure you’re getting the proper level of protection.
Tell me more about how masks are tested
The five performance metrics and their related tests are:
- Fluid Resistance – Test ASTM F1862
This test evaluates the resistance of a medical face mask to penetration by a small volume (~2 mL) of synthetic blood at a high velocity (80 mmHg, 120 mmHg, or 160 mmHg). The mask either passes or fails based on visual evidence of synthetic blood penetration.
- Breathability – Test MIL-M-36954 C: ΔP
This test determines the face mask’s resistance to airflow. A controlled flow of air is driven through the mask, and the pressure before and after is measured. The difference in pressure is divided by the surface (in cm2) of the sample. A lower breathing resistance indicates a better comfort level for the user.
- Bacterial Filtration (BFE) – Test ASTM F2101
This test measures the percentage of bacteria larger than 3 microns filtered out by the mask. The challenge material used is Staphylococcus aureus.
- Particulate Filtration (PFE) – Test ASTM F2299
This test measures the percentage of particles larger than 1 micron filtered out by the mask. The challenge material used consists of latex aerosol concentrations in a controlled airflow chamber.
- Flammability – Test 16 CFR Part 1610: Flame Spread
This test exposes the face mask material to a flame and measures the time required for the flame to proceed up the material a distance of 127 mm (5 inches). Class 1 means the material exhibits normal flammability and is acceptable for use in clothing.
ASTM F2100-11: Standard Specification for Performance of Materials Used in Medical Face Masks
|TEST||LEVEL 1 BARRIER||LEVEL 2 BARRIER||LEVEL 3 BARRIER|
|ASTM F1862(Fluid Resistance)||80 mmHg||120 mmHg||160 mmHg|
|MIL-M-36954 C: ΔP (Breathability)||< 4 mm H2O||< 5 mm H2O||< 5 mm H2O|
|ASTM F2101: BFE (Filtration 3μm)||≥ 95%||≥ 98%||≥ 98%|
|ASTM F2299: PFE (Filtration 1μm)||≥ 95% @ 0.1 micron||≥ 98% @ 0.1 micron||≥ 98% @ 0.1 micron|
|16 CFR Part 1610: Flame Spread (Flammability)||Class 1||Class 1||Class 1|
Does an ASTM-rated face mask provide all the protection I need? – It protects your nose and mouth against splashes and sprays of blood and other bodily fluids, as well as bacteria and particulate matter of the sizes indicated in the above table; however, face masks do not provide respiratory protection against airborne diseases. For that purpose, a respirator is required.
What is a respirator? – A respirator is a personal protective device that is worn on your face, covers at least your nose and mouth, requires fit-testing, and is used to reduce your risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases or vapors.
One of the most commonly used respirators is a NIOSH-approved N95 Respirator mask, which has been tested to filter out at least 95% of airborne particles. A Surgical N95 Respirator is a NIOSH-approved N95 Respirator that has been cleared by the FDA for use as a surgical mask. Unlike other masks, N95 respirators must be fit-tested for each individual to ensure proper protection.
For more information about the Respirators and surgical masks, click here.
Identifying 3 Ply Medical Masks From 3 Ply Non Medical Masks
Basic Classification of Masks
Medical masks are mainly used for medical protection and can be divided into three types:
- Medical protection mask
- Medical surgical mask
- Disposable medical mask
Non-medical masks are usually referred to as personal protective masks and can be divided into two types:
- Anti-particle mask
- Daily protective mask
Mask Categories in China
Below is usage information on the 5 classifications of medical and non-medical masks:
Medical Protection Mask
Suitable for use by medical staff in high-risk medical environments, such as outpatient clinics, isolation wards, and intubation areas.
Medical Surgical Mask
Suitable for use by medical staff when performing low-risk operations, as well as in environments such as medical institutions and crowded public places.
Disposable Medical Mask
Suitable for use by any person for medical purposes in an indoor work environment, during normal outdoor activities or in crowded public places.
Non- Medical Masks
Suitable for use by any person to filter out air particles in an industrial work environment.
Daily Protective Mask
Suitable for use by any person to filter out air particles in any polluted environment.
Guidance on How to Identify Medical / Non-Medical Masks based on Product Design and Package Information
- Medical masks generally do not have an exhalation valve so as to prevent droplets and microorganisms from passing through and coming into human contact.
- Non-medical masks, on the other hand, are allowed to have an exhalation valve.
- Package information for masks typically includes a product description, production standards and a protection level, e.g. “for medical use”. Check for terms including”医用” in Chinese or “Surgical” and “Medical” in English. This information can be used to determine how to classify the masks.
Guidance on How to Identify Medical / Non-Medical Masks based on Product Standards
Classification of masks differs across countries. Shippers should check for relevant Chinese or destination product standards to assist with determining how to classify the masks for export from China.
Chinese or destination product standards are typically available on the product packaging.
If necessary, obtain a product test report or certification from the product manufacturer.
Summary of Product Standards for Medical Masks in China, the United States (US) and Europe (EU)
Standard for Medical Protection Mask
Standard for Medical Surgical Mask
Standard for Disposable Medical Mask
Standard Specification for Performance of Materials Used in Medical Face Masks
Medical Face Masks. Requirements and Test Methods
China Product Standards
- Masks that fall into the following three Chinese standards are categorized as medical masks: GB 19083, YY 0469, and YY / T 0969.
- In China, medical masks are regulated by the National Medical Products Administration. Product registration information is available at:
US Product Standards
- Medical masks are classified as medical devices and are subject to the “Standard Specification for Performance of Materials Used in Medical Face Masks” (ASTM F2100).
- Medical masks can be sold only if they are registered under FDA Section 501K.
- Product registration information is available at:
- The FDA also publishes a list of Chinese manufacturers and corresponding respirator and mask models that it authorizes for import into the United States:https://www.fda.gov/media/136663/download
- Non-medical masks must be registered with the National Institute for Occupational Safety and Health (NIOSH) before marketing in the US can occur.
- If the above information is provided on the product packaging, the product can be considered a medical or non-medical mask.
- EU Product Standards and Certification
The Conformitè Europëenne (CE) mark is required for both medical and non-
medical masks, but with different standards.
o Medical masks are classified as medical devices and must have a CE
label affixed in accordance with EU Medical Device Directive (MDD) 93/42/EEC or Medical Devices (MDD) and Regulation (MDR) EU/2017/745 ((EN14683).
o Non-medical masks are not classified as medical devices but must meet the requirements of the EU Personal Protective Equipment Certification EU2016 / 425 (EN149).
Product registration information is available at: https://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13 andhttps://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
If the above information is provided on the product packaging, the product can be considered a medical or non-medical mask.