U.S. Releases Standard for Protective Masks

Release time:

2021-08-24

On February 15, 2021, ASTM released a new standard ASTMF3502 for masks. This standard is the first standard for protective masks used by ordinary consumers. The scope of application does not include masks used in medical environments regulated by the U.S. Food and Drug Administration (FDA) (medical masks) and respirators intended to be used as personal protective equipment (PPE) in workplace environments that require NIOSH approval. Protective masks are designed to provide source control by reducing the amount of droplets that spray from the wearer's nose and mouth, while providing protection by filtering particulate matter to reduce the wearer's inhalation.

1. Performance

(1) Filtration efficiency of submicron particles: Grade 1 (PFE)≥ 20%; Grade 2 (PFE)≥ 50%;

(2) Airflow (breathing) resistance: Level 1 inhalation ≤ 15 mmH2O, Level 2 inhalation ≤ 5 mmH2O;

2. General structure

(1) Designed to cover at least the user's face and mouth;

(2) Close fit to minimize leakage;

(3) Quantitative leakage assessment can be carried out through design analysis or using ASTMF3407;

(4) It is forbidden to include vents, valves or other functions that allow airflow to bypass the filter element of the barrier mask during exhalation;

(5) No sharp edges, sharp places or burrs;

(6) The retention system is used to cover obstacles on the user's nose and mouth to achieve the expected use and activity time;

(7) Dimensions.

3. Flammable

When tested according to 16 CFR1610, the material should be classified as Class 1 or Class 2.

4. Conformity assessment

(1) Model A requirements in the guideline ASTMF3050;

(2)PFE and air flow (breathing) resistance assessment must be carried out by a laboratory approved by the ISO17025 and conducting specific tests within its approved scope.

Labeling: Here are some key information needed for the product, packaging, or both

(1) Manufacturer's name and information;

(2)PFE performance and anti-airflow (breathing) ability (level 1 and level 2) or continuous performance diagram;

(3) Materials;

(4) Traceability information.

Reusable protective masks shall meet the performance requirements for sub-micron particle filtration efficiency and airflow resistance, in addition to the design analysis requirements for leakage evaluation in the receiving state and after the maximum number of uses and wash cycles specified by the manufacturer.

Currently, there are many protective masks available on the market. However, it is difficult for consumers to distinguish the performance of different products. The standard will be a useful tool for brands and retailers developing protective masks to evaluate the performance of products and communicate useful performance information to consumers with labels.

(Source: Jinqiao Textile Network)

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