In the course of the global pandemic triggered by the SARS-CoV-2 coronavirus, the need for face masks has increased enormously, not least due to the requirement to wear a mask in public spaces. There are important differences in the protective function between the "community mask", a (medical) mouth and nose mask and a respirator such as an FFP2 mask.
Here you can find out in detail which protective mask is the best.
In summary it can be said:
- The “community mask” or self-made mask does not offer any proven protection . Advertising claims about a protective function are not legal. At best, the motto here is: Better than none.
- The full-face protection provides foreign protection if it according to the standard DIN EN14683 was tested. More on this in a moment.
- FFP1, FFP2 or FFP3 masks offer self-protection and, if there is no exhalation valve, external protection . Protection can only be assumed with certainty if the masks have been subjected to a type test in accordance with DIN EN 149: 2001 + A1: 2009 . More on this in a moment.
HOW DO I RECOGNIZE A TESTED, SAFE FACE MASK?
Recognize certified mouth and nose protection (MNS)
The three-layer fleece masks with mostly blue or green outside are now available in many places, even at discount stores. But be careful: there are certified and non-certified masks. Outwardly there are hardly any differences. So pay attention to:
- CE mark
- Test according to DIN EN 14683: 2019
(Information can be found on the packaging)
Upon request or in the product description, the supplier / manufacturer should be able to provide the following documents:
- EU declaration of conformity from the manufacturer
- Test report according to DIN EN 14683: 2019
Masks that do not have these markings have not been tested or have not passed the test according to DIN EN 14683: 2019. They may offer less protection, but most likely none. Like self-sewn masks, these masks must not promise any protective function. Correct names would be makeshift mask, everyday mask or mouth and nose covering.
MNS may only be provided with the CE mark after compliance with the named DIN standard. Then you are considered a class I medical device according to Regulation (EU) 2017/745. They are also often called surgical mask, surgical mask or surgical mask. Medical face masks are differentiated between type 1 and 2. Type 1 surgical masks offer a bacterial filter performance of at least 95%, type 2 surgical masks of at least 98%. The addition "R" indicates the resistance to liquids.
Recognize certified respirators
In the context of this article, only FFP2 and FFP3 masks are considered, as these can be used to protect against the coronavirus. FFP1 masks do not provide adequate protection against the finest particles and aerosols.
As already described, FFP masks are primarily used for self-protection. They are therefore classified as category 3 personal protective equipment (PPE) . This includes equipment to protect against risks that could cause irreversible or fatal injury to the wearer. It is therefore obvious that these protective masks have to pass intensive tests.
DIN EN 149: 2001 + A1: 2009 specifies the properties to be tested, which must be determined in the context of an EC type examination by a designated EU body. Each notified body has a four-digit identification number that must be printed on each filter mask after a successful type test. Therefore, pay attention to the following information on the mask :
- CE mark
- Followed by a four-digit code *
- FFP protection level, e.g. FFP2
- EN standard 149: 2001
- Manufacturer Name
- item number
- still enclosed: application information
* There is also incorrect information when specifying this number. The number can be checked in the so-called NANDO directory . If the position exists, it must be named for "Regulation (EU) 2016/425 Personal protective equipment". If this is true, there is a high probability that it is a certified product. Last doubts can be dispelled by inquiring about the issued type examination at the notified body.
Upon request or in the product description, the supplier / manufacturer should be able to provide the following documents:
- Manufacturer's EU declaration of conformity
- EU type examination certificate
- Technical data sheet
The imprint "NR" (non reusable) indicates that the mask is intended for single use **. The imprint "R" (reusable) confirms the reusability.
** The RKI has made a recommendation for the reuse of respiratory masks, taking into account resource-saving use. Provided
- The mask is put on and taken off with washed / disinfected hands
- the mask is stored in a protected location
a disposable mask can also be reused. If the mask becomes damp / wet, it should be replaced.
If there are no markings on the protective mask, it can be assumed that it is not a certified FFP2 mask. You'd better stay away from this product.
ARE N95 MASKS OR KN95 MASKS SAFE?
Basically, N95 and KN95 masks do not meet the EU guidelines for personal protective equipment. A designation as an FFP2 mask is therefore wrong. In general, these products are not advisable because the protective function is not guaranteed. But there are N95 or KN95 masks that offer a similar security standard and are therefore exceptions. This is the case when:
- there is a special approval in accordance with Section 11 (1) of the Medical Devices Act
- a rapid test procedure according to the test principle (revision 3) for corona virus pandemic respirators (CPA) has been passed
Masks with special approval according to Section 11, Paragraph 1 of the Medical Devices Act
To ensure the supply of protective masks at the height of the corona crisis, protective masks without a CE mark were separately approved. These are considered medical devices and not personal protective equipment. These masks are actually only approved for distribution to medical institutions. The special admissions were limited until June 30, 2020 and July 31, 2020.
Corona Virus Pandemic Respirators (CPA)
As a successor to the interim solution “Special Approval”, the Federal Government has passed the “Medical Needs Supply Guarantee Ordinance - MedBVSV” on the basis of the Infection Protection Act. On the basis of §9 MedBVSV, the market surveillance authorities are now checking the marketability of so-called corona pandemic respiratory protection masks (CPA).
In a simplified test procedure, the minimum requirements for suitability for infection protection are determined by DEKRA, ZLS and IFA bodies. This does not replace certification, but merely informs that, as an exception, the tested masks do not have to be taken off the market until the end of the pandemic.
A CPA mask must be clearly named as such and must not bear any misleading markings such as the CE mark, FFP2 or FFP3 or EN 149: 2001, either on the product or the packaging.
What to look for when buying protective visors?
When it comes to derogations, protective visors must also be mentioned. Face visors are basically category 2 personal protective equipment. Protection against mechanical impacts such as splinters is important. To protect against droplet infection, you don't need a hard plastic visor like you might know from a motorcycle helmet. For example, a shortened type test was designed for protective visors, which excludes protection against mechanical influences.
Many of the visors offered, especially the self-made brand, have not passed a shortened type examination and are therefore not marketable. Therefore, pay attention to:
- Affixing the CE mark to the product or packaging
- Reference to type approval in product information enclosed or in the product description
By applying the EN 166: 2001 standard, these protective visors are considered medical products according to Directive 93/42 EEC.