EN 14683: Medical Face Masks - Requirements and Test Methods

EN 14683 Standard, Scope, Test Procedures...

EN 14683: Medical Face Masks

With the corona virus outbreak, the use of masks has become mandatory. However, the masks to be used must pass certain tests and analyzes within the scope of the EN 14683 standard.

Mask types covered by the EN 14683 standard:

The EN 14683 standard covers the test procedures performed on Type I, Type II, Type IIR medical masks.

Type I Medical Face Masks: Masks used to prevent the spread of microorganisms in epidemic and pandemic situations.
Type II Medical Face Masks: Generally used by healthcare workers in medical environments such as operating rooms.
Type II and Type IIR medical face masks are generally used for healthcare personnel and are evaluated according to their splash resistance.

Testing and analysis within the scope of EN 14683 standard and its limits:

Test	Tip I	Tip II	Tip IIR
Bacteria Filtration Efficiency (BFE) (%)	≥ 95	≥ 98	≥ 98
Pressure difference (Pa/cm2)	< 40	< 40	< 60
Splash Resistance Pressure (kPa)	Not Required	Not Required	≥ 16,0
Microbial Cleaning Level (kob/g)	≤ 30	≤ 30	≤ 30

Tests performed on medical masks within the scope of ASTM F2100-11: "Standard Specification for the Performance of Materials Used in Medical Face Masks", except EN 14683:

ASTM F1862	Standard Test Method for Resistance of Medical Face Masks to Synthetic Blood Penetration (Horizontal Projection of Constant Volume at Known Speed)
MIL-M-36954 C	Military Features - Mask, Surgical, Disposable - Breathability
ASTM F2101	Standard Test Method for Evaluating Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials
16 CFR Part1610	The Flammability Standard of Clothing Textiles
ASTM F2299	Standard Test Method for Determining Initial Effectiveness of Materials Used in Medical Face Masks to Penetration of Particles Using Latex Spheres

Application Areas of EN 14683

EN 14683 applies to a wide range of medical face masks to ensure their safety and effectiveness. These masks are widely used, particularly in the following areas:

Hospitals and Healthcare Organizations:

Medical face masks prevent the transmission of microorganisms between patients and healthcare workers during the treatment of patients.

Surgical Procedures:

Surgeons and other healthcare workers prevent the passage of blood, fluids and microorganisms by wearing surgical masks.

Emergencies and Pandemics:

During pandemic diseases (e.g., COVID-19), masks play a critical role in reducing the risk of infection between healthcare workers and patients.

Dental and Other Medical Procedures:

In fields such as dentistry, masks protect healthcare workers in direct contact with patients.

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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