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How Certified Face Masks Are Tested

Updated: Feb 28, 2023

The quality of the PPE products you use at your organization matters. To ensure the highest level of protection, use only certified face masks approved by the relevant regulators.

Below, you can learn some basic facts about testing and certification involving the three most common types of face masks used for protection against the coronavirus.

Medical masks

Medical face masks are considered medical devices and are therefore covered by national medical device regulations. These regulations aim to ensure that medical masks provide a certain level of protection against risks. Evaluation areas include (but are not limited to):

· Registration and approval

· Classification designations

· Marking and labeling

· Particulate Filtration Efficiency (PFE)

· Bacterial Filtration Efficiency (BFE)

· Breathability


Respirators are used both in commercial environments and health care settings, when respiratory and fluid resistance are required. Examples of these type of respirators include:

· United States and Canada: N95

· China: KN95, KP95


· Australia: P2/P3

Due to their commercial use, respirator regulations are the jurisdiction of the country’s workplace safety agency. Evaluation areas include (but are not limited to):

· Certification and approval

· Classification designations

· Marking and labeling

· Particle Filtration Efficiency (PFE)

· Breathing Resistance

· Leakage

Fabric masks

Since a fabric mask is in direct contact with the skin for potentially long periods of time, testing for restricted substances and biocompatibility is highly encouraged. Fabric mask tests are designed to evaluate different specifications, but the most important one is barrier performance. Most countries have adopted particulate filtration efficiency (PFE) as the major barrier performance, while bacterial filtration efficiency (BFE) is specified in Spain and Portugal.

Country-specific regulations

Different types of masks are subject to varied country-specific regulations and classifications. In the EU, the harmonized European standard EN 14683:2019+AC:2019 classifies medical masks as Type I and Type II, depending on their bacterial filtration efficiency. In the United States, the testing for materials used in masks is provided by the American Society of Testing and Materials (ASTM). Medical face mask materials are designated as one or more of the following performance classes: Level 1 barrier, Level 2 barrier, and Level 3 barrier.

Test methods also vary. In France, for example, fabric masks are tested via dissolved gas analysis (DGA). In Belgium, testing is based on the EN 13274-7 standard for filter penetration properties of respiratory protective devices.

To ensure that the masks you procure offer maximum safety and protection, buy only PPE products that comply with the specific regulations in your country. Avoid procuring PPE whose effectiveness is not verified by the relevant certificates.

Source: SGS

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