Navigation and service

If you use services from this provider, usage data may be collected and, if applicable, stored in server logs. On the type and extent of the transmitted or. The BfArM has no influence on the data stored in the data base. Continue to Twitter

The Corona pandemic (SARS-CoV-2 pandemic) and the covid-19 illnesses triggered by the virus have greatly changed our daily lives. One of the most obvious changes comes from the now mandatory masking in many areas. By wearing the masks, citizens can make their contribution to preventing the unhindered spread of the so-called "coronavirus" (SARS-CoV-2). This is intended to reduce the transmission of the virus from person to person and consequently the risk of possible infection.

There are various types of masks, some of which differ significantly in their design and protective effect. The BfArM would like to provide an overview here and explain the characteristics of the mask types in more detail.

Overview of different types of masks

The wearing of masks is always only one part of a comprehensive protection concept, with which we jointly fight against the spread of the coronavirus. Therefore, the "AHA+L" formula still applies: Keep your distance, pay attention to hygiene, wear an everyday mask and ventilate.

When using masks, the following should be considered:

Recommendations for handling masks

Among the masks currently used in infection control, a basic distinction is made between three types of masks:

There are Mouth-nose coverings, the z.B. also called everyday masks, auxiliary mouth-nose masks; community masks.
The masks known from everyday medical use medical face masks, colloquially for example also OP – masks, mouth nose protection, mouth guard called. These are "medical devices".
And the so far predominantly to the range handicraft admits particle filtering half masks, colloquially known as FFP masks. The name FFP is an abbreviation derived from the English name of the masks "Filtering Face Piece. These masks belong to the product category "Personal Protective Equipment" (PPE).

These mask types offer different levels of protection against transmission of the SARS-CoV-2 virus due to their respective properties. In their resolution of 19.01.2021 also indicate that surgical masks as well as masks of the KN95/N95 or FFP2 standards have a higher medical protective effect than everyday masks, which are not subject to any standardization with regard to their protective effect.

The FFP2 and FFP3 masks, which are part of the personal protective equipment, as well as masks that can be marketed in Germany according to the KN95/N95 standards, which are comparable with regard to SARS-CoV-2 infection protection, are also tested for their filtering performance for aerosols on the basis of the standards that apply to them. Their protective effect against the SARS-CoV-2 virus is considered to be higher than that of surgical masks due to their proven higher filtration efficiency and because of their better seal fit.

1. "Mouth-to-nose covering"

Mouth-nose coverings, unlike medical face masks or particle-filtering half masks, are not tested according to corresponding legal and normative requirements. Therefore, they can be placed on the market without these regulatory procedures. So there are no regulatory requirements for the substances used to make these masks z.B. to the filtering performance, but there may be specifications z.B. be applicable to the freedom of the textiles used from harmful substances. In most cases, these masks are sewn from commercially available fabrics. Their appearance and tightness are correspondingly varied, as the materials used differ in design and material properties. They are worn in everyday life and therefore colloquially often called everyday masks.

The distinction from medical devices or from personal protective equipment is important. Everyday masks are not allowed to be advertised with corresponding performance or protective effects, because they did not have to pass any test procedures according to such requirements. Therefore, everyday masks may not be sold as medical devices or products of personal protective equipment.

Everyday masks do not provide the performance evidence defined in the technical standards as required for medical face masks and particle filtering half masks. They therefore generally offer less protection than these regulated and tested mask types. But this does not mean that they have no protective effect. Internationally, there are numerous scientific publications that confirm the experience gained about the effectiveness of the mouth-nose coverings in terms of general population protection (1, 2, 3, 4, 4a, 5, 6, 7). In this case, the protective effect of the masks depends on the tightness and quality of the material used, the adaptation to the shape of the face and the number of layers of fabric. Firmly woven fabrics, for example, are more suitable than lightly woven fabrics in this context. Thus, according to the current state of knowledge, the correct wearing of good everyday masks can significantly reduce the risk of exposure to droplets containing pathogens.

A special group of everyday masks are those manufactured according to a special standard, the European CEN Workshop Agreement CWA 17553. While these masks are also everyday masks and thus neither personal protective equipment nor medical devices with corresponding mandatory testing requirements and regulatory oversight, the CWA still imposes specific performance requirements on these masks. They must filter at least 70 % or 90 % of particles with a diameter of 3 (± 0.5) micrometers.
Although this is based on a separate standard, these masks, like other everyday masks, are not subject to any special governmental or other regulatory oversight, such as.B. Medical devices or personal protective equipment. The manufacturer is solely responsible for the implementation of the specifications. Nevertheless, if the standard is applied correctly, this marking can be a sign of quality.

How to recognize such a mask?

Everyday masks are usually sewn masks made of commercially available fabrics. Their design is often reminiscent of regular clothing and is correspondingly versatile. They do not carry CE marking.

The special group of everyday masks manufactured in accordance with CWA 17553 are labeled "Community face coverings CWA level 70 %" or "Community face coverings CWA level 90 %".

How the mask differs from an FFP mask/OP mask?

The filtering performance and thus the protective properties of everyday masks can vary greatly depending on the design and the material used. However, everyday masks are basically suitable to a certain extent for capturing droplets and brakes of exhaled air.
FFP masks and OP masks are always made of special filtering fleeces. The filtering properties of these masks have been tested and proven in accordance with legal requirements and technical standards. Define technical standards z.B. clear requirements for the filtering performance of the mask material used.

What a manufacturer must not promise for everyday masks?

When describing/advertising an oral-nasal covering by the supplier, care must be taken not to give the impression that it is a medical device or personal protective equipment. It is particularly important that the designation and advertising of the mask should not imply a proven protective function if it is not in accordance with the normative specifications or. has been tested in accordance with the procedures provided for by law. In fact, it should be explicitly stated that it is neither a medical device nor personal protective equipment.

What to pay attention to when using?

Wearing masks is only one part of a comprehensive protection concept that we are using in Germany to combat the spread of the coronavirus. Therefore, the "AHA+L" formula still applies: Keep your distance, pay attention to hygiene, wear an everyday mask, and ventilate.

When using everyday masks, be aware of the following:

Masks should be used for private use only.
The hygiene tips contained in the recommendations of the Robert Koch Institute (RKI) and the Federal Center for Health Education (BZgA) should be followed. This is the only way to protect ourselves and others from the spread of the coronavirus.
Even when wearing a mask, the safety distance of at least 1.50 m from other people recommended by the RKI should be maintained.
The mask must fit well and sit over the mouth, nose and cheeks. The edges of the mask should fit snugly so that as little air as possible is breathed past the mask. It’s best to try different mask shapes until you find one that suits you best.
When first used, the mask should be tested to determine whether it allows sufficient air to pass through to minimize obstruction to normal breathing.
A soaked mask should be removed and changed.
When putting on and taking off the mask, it should be handled only by the straps of the mask, if possible.
After removing the mask, hands should be washed thoroughly in compliance with general hygiene rules (at least 20 to 30 seconds with soap).
The mask should be placed in a bag after removal o.a. be stored in an airtight container or washed immediately. They should only be stored for as short a time as possible, especially to avoid mold growth.
Masks should ideally be washed at high temperatures. Preferably at 95 degrees, but at least at 60 degrees. Do not use short wash programs and then allow to dry completely. Be sure to follow any other manufacturer’s instructions, such as z.B. the number of washes the mask can withstand without losing its function.

2. Medical face masks

Medical face masks are medical devices and were developed for the protection of others. They protect above all the opposite from delivered infectious droplets of the mouthguard wearer. However, medical face masks, when fitted tightly, can also protect the wearer of the mask, even if this is not their actual function. In the clinic, they are z.B. Used to prevent droplets from the physician’s breath from entering a patient’s open wounds.

Due to the shape and fit of most medical face masks, some of the breathing air can flow past the edges. Especially during inhalation, unfiltered air can be drawn in through this so-called "leakage flow". Therefore, medical face masks generally provide less protection to the wearer from pathogen-containing aerosols than do particle-filtering half masks (see below). However, medical face masks can protect the wearer’s mouth and nose from direct exposure to exhaled droplets from the other person, as well as from pathogen transmission through direct contact, such as with contaminated hands.

Medical face masks are medical devices. Their manufacture and distribution must be in accordance with medical device law. (More detailed information can be found z.B. on the website of the German Federal Ministry of Health.

How to recognize such a mask?

Medical face masks are known from the hospital or the doctor’s office. They are made of special plastics, are rectangular with folds and are usually green or blue on the front (outside). The back (inside) is white. They have ear loops and noseband made of wire or metal strips.

How the mask differs from an FFP mask or everyday mask?

Medical face masks have clearly defined filtering properties and serve primarily to protect others. The properties of the medical masks are defined by law and technical standard and must be observed by manufacturers. The masks are manufactured industrially. Unlike everyday masks, they are always made of multilayer plastics with specific properties and contain a special filter fleece ("meltblown fleece") embedded between two layers of other material.
Everyday masks, on the other hand, do not have filtering properties defined by standards and are not subject to any corresponding legislation. They are usually made of commercially available materials.
FFP masks, like surgical masks, are always made of special filtering nonwovens. The filtering properties of these masks have been tested and proven against the clear specifications of standards. The masks, like medical devices, have gone through a special process required by law before they can be marketed in Europe.

What may a manufacturer promise for such masks? How were they tested??

Medical face masks are medical devices. Their manufacture and distribution must be in accordance with the legal requirements for medical devices.
Medical devices, unlike everyday masks, are subject to special requirements. They must therefore comply with the European standard EN 14683:2019-10. For this purpose, manufacturers must carry out a successful verification procedure (conformity assessment procedure according to Medical Devices Directive 93/42/EEC) to prove that their products meet all legal requirements. Only then can manufacturers affix the CE mark to medical masks and sell them freely in Europe.

What do I have to consider as a manufacturer?

The manufacturer of medical face masks produces medical devices. He bears full product responsibility as the responsible person according to § 5 of the Medical Devices Act (MPG ).
For more information, click here: Placing medical devices on the market

What to pay attention to during use?

Wearing masks is only one part of a comprehensive protection concept we use in Germany to fight the coronavirus. Therefore, the "AHA+L" formula still applies: Keep your distance, pay attention to hygiene, wear an everyday mask and ventilate.

The tips on hygiene, as given in the recommendations of the Robert Koch Institute Robert Koch Institute (RKI ) and the Federal Center for Health Education (BZgA ), should be followed. This is the only way to protect ourselves and others from the spread of the coronavirus.
Even with a mask, the safety distance of at least 1.50 m from other people recommended by the RKI should be maintained.
The mask must fit well and fit over the mouth, nose and cheeks. The edges of the mask should fit tightly so that as little air as possible is inhaled past the mask. By adjusting the length of the ear loops (z.B. nodes), the tight fit can be improved.
When using the mask for the first time, it should be tested whether it allows enough air to pass through, so that normal breathing is impeded as little as possible.
A soaked mask should be removed and changed.
When removing the mask, it should only be touched by the straps of the mask if possible.
After removing the mask, hands should be washed thoroughly (at least 20 to 30 seconds with soap) in accordance with general hygiene rules.
The masks are intended by the manufacturer as disposable products. They should be changed regularly and disposed of after use.

3. Particle-filtering half masks (FFP masks)

Filtering half masks (FFP2 and FFP3)

FFP masks, as items of personal protective equipment, serve primarily to protect the mask wearer from particles, droplets and aerosols. The masks are intended by the manufacturer as disposable products. They should be changed regularly and disposed of after use. They must fit close to the face in order to develop their filtering performance.

The design of FFP masks varies. There are masks without exhalation valve and masks with exhalation valve. Masks without an exhalation valve filter both inhaled air and exhaled air across the mask surface, and therefore provide both self-protection and external protection. Masks with a valve have a much lower degree of external protection. Exhaled aerosols are not intercepted by the filter material, but merely slowed down and swirled to a certain extent by the valve.

Further information on the legal marketing of personal protective equipment products in Germany can be found on the homepage of the Federal Institute for Occupational Safety and Health (BAuA ).

Multiple use of FFP2 masks

In principle, FFP masks are intended by the manufacturer as single-use products and not for reuse. Nevertheless, in the private sector, these masks are often used several times in everyday life, even on several consecutive days.
Against this background, the BfArM is currently funding a research project at the Munster University of Applied Sciences and the Westfalische Wilhelms-Universitat Munster to scientifically clarify the possibilities and risks associated with such handling in practice. There are simple procedures being studied that significantly reduce the risk of infection when FFP2 masks are reused in the private sector. The results obtained so far have been published by the project participants in an information flyer. On 03.03.2021 saw the publication of the new edition of the flyer 2.0.

The procedures described in detail in the flyer were tested on several FFP2 masks of different designs as examples. The investigations show that after 7 days of storage, the amount of infectious coronaviruses (SARS-CoV-2) on and in the masks could be reduced to an acceptable level. In the alternatively described disinfection by boiling in a freezer bag for 10 minutes, the coronavirus is completely inactivated under the conditions explained in the flyer, and other germs of the skin, nose and throat flora are almost completely inactivated. In the tests, both procedures led neither to a significant loss of filter performance nor to a change in the mask that would render it unusable. For both procedures, it is extremely important to follow the instructions described in the flyer exactly. The masks used so far in flyer version 1.0 described disinfection in the oven is also still possible and is still mentioned in the flyer. However, since the method of boiling in a freezer bag is much easier to perform, it has now been brought to the forefront.

The procedures developed in the research project and described in the information flyer of the Munster University of Applied Sciences and the Westphalian Wilhelms University of Munster are, according to current knowledge, fundamentally suitable for significantly reducing the risk of infection when FFP2 masks are reused in private use. Nevertheless, it should be pointed out that the procedures presented in the flyer cannot guarantee safe protection against infection and that, if possible, appropriate masks should only ever be used according to the manufacturer’s instructions, even in private use.

How to recognize such a mask?

FFP masks or particle-filtering half masks are often dome-shaped or foldable ("coffee filter shape"). They do not have classic seams, but are industrially manufactured, but can have "weld seams" or "weld points" where material is still present, but this is almost transparent. They are comparatively more rigid than surgical masks or everyday masks. This is because they have more and different filter layers.

How does the mask differ from an OP -mask/MNS ?

FFP masks, like OP masks, are always manufactured using special filtering fleeces. They are items of personal protective equipment. They serve equally for personal and external protection, provided they do not have a valve. If FFP masks have a valve, the external protection is limited, as the air essentially escapes unfiltered when exhaling.
The properties of FFP masks are defined by law and standard and must be complied with by manufacturers. The filtering properties are tested against the specifications of standards and are thus verified. Standards define clear requirements for the filtering performance of the mask material used.
Like OP masks, FFP masks are always made of multilayer plastics with specific properties. As a rule, they also contain a special filter fleece ("meltblown fleece"), supplemented by further filter layers, embedded between two layers of fabric made of other materials. The filtering layers may vary depending on the manufacturer and the performance class of the masks. (Filter performance FFP 1 = filter at least 80 %, FFP 2 = at least 80 %). 94%; FFP 3 = min. 99% (based on the test aerosol used))
Medical face masks have clearly defined filtering properties and serve primarily to provide external protection. They are made of multi-layer plastics with specific properties and contain a special filter fleece ("meltblown fleece") embedded between two layers of other material.
The everyday masks, on the other hand, do not have filtering properties defined by standards and are not subject to legislation. They are usually made of commercially available materials.

What may a manufacturer promise for such masks? How they were tested?

FFP masks are items of personal protective equipment (PPE). Their manufacture and distribution must be in accordance with the legal requirements for personal protective equipment.
These masks may be advertised for intrinsic and extrinsic protection, provided they do not have a valve.
FFP masks, unlike everyday masks, have to meet special requirements. They must therefore meet the legal requirements and comply with the European standard EN 149:2001+A1:2009. For this purpose, manufacturers must carry out a successful verification procedure (conformity assessment procedure including a type examination in accordance with PPE Regulation (EU ) 2016/425) to prove that their products comply with all legal requirements. Only then can manufacturers affix the CE mark to FFP masks and sell them freely in Europe.
The protection class and requirement for single use must be clearly marked.

What do I have to consider as a manufacturer?

In order to legally place particle-filtering half masks on the market in Europe, they must undergo a conformity assessment procedure in accordance with the PPE Regulation (EU) 2016/425 with a Notified Body and a type examination. They must meet the requirements of the European standard EN 149:2001+A1:2009 for this purpose. Only then may the masks be CE marked in accordance with the PPE Regulation and be freely marketable in Europe.
The competent authorities of the federal states are responsible for the legal marketing of PPE in Germany. On the homepage of the Federal Institute for Occupational Safety and Health (BAuA ) you will find more information, e.g.B. on placing on the market and other standards.

What to look for when using?

Wearing masks is only one part of a comprehensive protection concept that we use in Germany to combat the coronavirus. Therefore, the "AHA+L" formula disseminated by the Federal Ministry of Health still applies: Keep your distance, pay attention to hygiene, wear an everyday mask, and ventilate.

The tips on hygiene as given in the recommendations of the Rober-Koch-Institut (RKI ) and the Bundeszentrale fur gesundheitliche Aufklarung (BZgA ) should be followed. The only way to protect ourselves and others from the spread of coronavirus.
Even when wearing a mask, the safety distance of at least 1.50 m from other people recommended by the RKI should be maintained.
The mask must fit snugly and sit over the mouth, nose and cheeks. The edges of the mask should fit snugly and not allow airflow past the mask. An FFP mask can only provide its full filtering performance if it fits tightly.
When using for the first time, test to see if the mask allows enough air to pass through to minimize obstruction of normal breathing.
A soaked mask should be removed and changed.
When removing the mask, it should always be grasped by the straps of the mask, if possible.
After removing the mask, hands should be washed thoroughly (at least 20 to 30 seconds with soap) in compliance with general hygiene rules.
Masks are intended by the manufacturer to be disposable. They should be changed regularly and disposed of after use.

4. Face visors

If there is uncertainty as to the quality of the face visors or shields you have purchased, ask the vendor to classify them. Ask whether the products are medical devices or products of personal protective equipment, and whether the products comply with the laws or technical standards that exist for this purpose.

5. Further links and literature references:

For more information on the proper selection of masks, visit the websites of the

Literature references:

Chu DK, Akl EA, Duda S, Solo K, Yaacoub S, Schunemann HJ; COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020 Jun 27;395(10242):1973-1987
Sanjay Beesoon, Nemeshwaree Behary, Anne Perwuelz. Universal masking during COVID-19 pandemic: Can textile engineering help public health?? Narrative review of the evidence. Prev Med. 2020 Oct;139:106236.
Colin J., Hsiao-Han. Face mask use in the general population and optimal resource allocation during the COVID-19 pandemic. Nat Commun. 2020; 11: 4049.

4a. Abhiteja Konda, et al. Correction to Aerosol Filtration Efficiency of Common Fabrics Used in Respiratory Cloth Masks. ACS Nano 2020, 14, 8, 10742-10743

Further information

Information on the coronavirus in connection with the regulatory tasks of the BfArM