EN 14683 Type Medical Mask Instruction: Explain in Details

COVID-19 Omicron is raging, although adults infected is not a big deal, but for children and families will still cause a lot of trouble, wear a variety of masks can effectively reduce the infectivity, the EN 14683 type medical mask can effectively block the transmission of the virus, but most do not really understand the EN 14683 type medical masks, today I will take you from three aspects to understand the EN 14683 medical masks.

• What is EN 14683 type medical mask?
• How to identify EN 14683 type medical masks?
• What are the requirements of EN 14683 type medical masks?

What is EN 14683 type medical mask?

EN 14683 is the EU medical mask standard. EN 14683 mask, a health product, which refers to wear in the mouth and nose part used to filter the air into the mouth and nose, in order to block harmful gases, droplets in and out of the wearer’s mouth and nose. The mask can effectively block droplets and other pollutants to protect the wearer from infection, especially in the case of influenza or worldwide epidemics, which play a very important role.

EN 14683 medical masks have three types: Type I^a, Type II, Type IIR

Based on bacterial filtration efficiency, EN 14683 medical masks are divided into two groups.

1 In general, Type I^a masks with 95% filtration performance are used in inpatient and general places to reduce the risk of infection transmission; such masks are not intended for use in operating rooms or by medical professionals in healthcare facilities. This type of medical mask can be used to reduce the risk of infection and transmission in populations, especially in the case of pandemic infectious diseases.

2 On the other hand, Type II and Type IIR masks have 98% filtration performance and are designed for use by physicians and medical workers. The difference is that Type IIR medical masks are resistant to splash, such as blood, which is not required for Type II. Therefore, each type of mask has different requirements.

Test	Type Ia	Type II	Type IIR
Bacterial filtration efficiency (BFE), (%)	>95	>98	>98
Splash resistance pressure (kPa)	Not required	Not required	>16.0

As you can see from the above, for this COVID-19, it is not necessary to wear Type IIR masks if you are not a medical worker. For Type I^a and Type II masks, the difference in bacterial filtration efficiency is not too big and can be worn by general personnel.

In addition, EN 14683 is the European standard, and its counterpart ASTM F2100 is the American standard, which also has three levels, Level 1, level2, and level 3, and the test content terms are basically similar. If you want to know the content of ASTM F2100 level masks, please refer to this article: https://www.testextextile.com/face-mask-of-astm-f2100-level-people-who-wear-masks-should-know/

Unlike protective masks (N95 mask or FFP mask), because an important role of medical masks is to keep the wearer from infecting other people, they cannot have breathing valves, and in addition, EN 14683 medical masks cannot be washed and are disposable masks.

However, in reality, when we get an EN 14683 mask, it seems that it all looks the same except for the different colors, so how can we tell which type they really are?

How to identify EN 14683 type medical masks?

For mask wearers, when we get an EN 14683 medical mask, then it must come with the packaging, where there is all the information we need.

First of all, on the front of the mask package, the type of mask is usually marked, as shown below, where it is written that the mask is single-use, belongs to the medical mask Type IIR, has three layers of protection, as well as the size of the mask, is 17.5cm X 9.5cm, the number of 50pcs in a box and other information.

Secondly, on the side of the mask package, there is the certification information of the mask product, the manufacturer’s address, website, other contact information, etc. These are to help us determine whether the mask is in compliance with the requirements of the EN 14683 standard, that is, whether it is a safe and quality-qualified product.

For mask wearers, just understanding this information is basically enough, but for mask dealers and mask manufacturers, just understanding this is not enough, we must also understand what are the requirements of EN 14683 masks and how they should be tested?

What are the requirements of EN 14683 type medical masks?

For COVID-19, the protective performance of EN 14683 type masks depends on factors such as filtration efficiency, material quality, and the fit of the mask to the wearer’s face. EN 14683 mask standard is a European regional test requirement for facial protection products, whether you are a mask manufacturer, seller, or mask user, many of you may not be aware of the requirements of this standard.

Material and structure requirements

Medical masks, usually consist of an outer layer of protective non-woven fabric, a middle layer of filtering meltblown fabric, and an inner layer of skin-friendly non-woven fabric. During use, medical masks should not tear easily. When choosing the material for the filter layer, attention should be paid to cleanliness.

The filtering performance of the mask can vary according to the different filtering materials, and the fit of the mask to the human face has a certain relationship with the earloop or tie of the mask, the nose bridge strip, and the size of the mask. In addition, the appearance of the mask should be neat and intact in shape, and the surface should not be broken or stained.

Medical masks should be constructed to meet this requirement, to fit snugly over the wearer’s nose, mouth and chin, and to ensure a tight fit on both sides of the mask. Medical masks can come in different shapes and configurations, as well as additional features such as anti-fog features. Currently, the prevalent medical masks are of a flat type design.

Use performance requirements

EN 14683 type medical masks, in the process of use, to meet the relevant use performance to ensure the safety of the mask, including the following specific aspects.

Test	Type Ia	Type II	Type IIR
Bacterial filtration efficiency (BFE), (%)	>95	>98	>98
Differential pressure (Pa/cm 2)	<40	<40	<60
Splash resistance pressure (kPa)	Not required	Not required	>16.0
Microbial cleanliness (cfu/g)	<30	<30	<30

1 Bacterial filtration efficiency (BFE)

Bacterial filtration efficiency (BFE) refers to the ability of the mask material to filter bacterial particulate matter, expressed as a percentage, when tested with a mask bacterial filtration efficiency tester under specified conditions. Bacterial filtration is the main factor to measure the protective effect of the mask. For COVID-19, we should choose the mask with a high filtration effect in intensive places.

When a mask consists of two or more areas with different characteristics or different layer compositions, each panel or area shall be tested individually. The lowest-performing panel or area shall determine the BFE value of the complete mask.

2 Differential pressure / Breathability

In addition to achieving a certain protective effect, the mask must also consider comfort. The differential pressure of the mask, also called breathability, is one of the main factors affecting the comfort of wearing the mask. If the breathability is not good, consumers will feel breathing difficulties when wearing, and improper use may cause serious consequences. The differential pressure performance of the mask is tested by the mask differential pressure tester.

It should be noted that the differential pressure of the mask and the filtering performance of the mask are relative, and the filtering performance is good, but the breathability is poor. Therefore, under the premise of being able to meet the protection effect, we should try to choose masks with good breathabilities, such as the general population, or ordinary places, we only need to wear EN 14683 Type I^a masks.

3 Splash resistance / Synthetic blood penetration resistance

Splash resistance / Synthetic blood penetration resistance is a requirement unique to EN 14683 Type IIR masks, which are mainly used in the operating room, mainly to prevent splashing of patient’s blood onto the doctor’s face during surgery, etc., and therefore, for the COVID-19 epidemic, the general population does not need this performance.

4 Microbial cleanliness (Bioburden)

Microbial cleanliness refers to the freedom from the population of viable micro-organisms on a product and/or a package. When tested according to EN ISO 11737-1: 2018 the bioburden of the medical mask shall be W 30 CFU/g tested.

EN ISO 11737-1: 2018 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material, or package.

5 Biocompatibility

quality of being accepted in a specific living environment without adverse or unwanted side effects

According to the definition and classification in EN ISO 10993-1: 2009, a medical face mask is a surface device with limited contact. The manufacturer shall complete the evaluation of the medical face mask according to EN ISO 10993-1: 2009 and determine the applicable toxicology testing regime. The results of testing should be documented according to the applicable parts of the EN ISO 10993 series. The test results shall be available upon request.