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Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

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08.12.2020

New masks due to the pandemic

Now that the circle of mask wearers has expanded considerably, it is important to take a close look at the innovations on the market and how different their evaluation can be.

Masken-und-Kollaborationen
Masken-und-Kollaborationen
Masken-und-Kollaborationen
Masken-und-Kollaborationen

Necessity is the mother of invention. This is also true in times of a worldwide pandemic, which leads to a sudden shortage that would have been unforeseeable a year ago for the vast majority of medical device manufacturers, authorities, but also wearers.

This sudden increase in the demand for medical masks, but also masks without medical indication, has led to new product ideas, but also test approaches in various areas. 

A first example of novel mask types would be mouth-nose covers made of transparent material. They offer various advantages for the mask wearer and his counterpart. The wearer and his or her counterpart can make better use of their facial expressions in a personal conversation in addition to their actual speech. This is an important advantage for areas where direct exchange is the main focus: during consultations, at the exhibition stand or in private areas. A forerunner of this type of mask, which has also been mentioned in the press several times, is the "Smile-By-Ego" mask. This mask has been classified as a mouth-nose covering (Mund-Nasen-Bedeckung) by the Bavarian State Ministry of Health and Care. But what does "mouth-nose covering" actually mean and what distinguishes it from a mouth and nose protector (Mund-Nasen-Schutz)? An overview:

Mask type/properties

Mouth-nose covering

Medical face mask

Particle filtering half masks

Abbreviation/Synonym

DIY mask, 

Temporary mouth and nose mask, 

Community Mask

Mouth and nose protector,

MNP, 

Surgical (surgical) mask (only type II and IIR according to standFFard)

FFP1 mask, 

FFP2 mask, 

FFP3 mask

Intended use

Private use

External protection

Self-protection, industrial safety

Regulatory classification, applicable legal basis

European Product Safety Directive 2001/95/EC,

German law (including the Food, Consumer Goods and Feed Code)

Medical device according to Medical Device Directive 93/42/EEC or Medical Device Directive 2017/745

German Medical Devices Act or Medical Device Implementation Act

Regulation on personal protective equipment 2016/425

Protection

generally not proven, wearing it can reduce the speed of the respiratory flow or the saliva/mucus droplet ejection

External protection according to DIN EN 14683:2019

Self-protection according to DIN EN 149:2009

Source: www.bfarm.de/DE/Service/Presse/Themendossiers/Coronavirus/_node.html

 

How does the Bavarian Ministry of State evaluate a transparent cover? Once again, we refer to the example of the Smile-By-Ego mask:

 

The Infection Protection Act specifies areas in which a "mask" must always be worn, regardless of the actual risk situation. [...] As can be seen from the name of the mask, from a legal point of view it is suitable as a community mask if the mouth and nose are covered by the mask when worn and the exhaled air and its flow is diverted. [...] Face masks do not fulfil these conditions. The StMGP does not "recommend" the "smile-by-ego" masks and has not "approved" them, as is often falsely claimed - it has only determined that they meet the definition of "mouth-nose covering" and can be used accordingly. However, on the basis of occupational health and safety law, the SARS-CoV-2 occupational health and safety regulation provides for mouth-nose covering* under certain conditions. [...] A mask such as "Smile-by-Ego" cannot be accepted in principle in this case. In hotels and restaurants, for example, the smile-by-ego mask complies with the SARS-CoV-2 health and safety regulation if the general conditions (e.g. sufficient ventilation, distance, etc.) would not require a mouth-nose covering* but the Infection Protection Act requires a mask.

(*Note: According to the RKI overview table, this probably refers to a mouth and nose protector and not a mouth-nose covering)

 

This means that in Bavaria, a transparent cover is equivalent to a self-sewn mouth-nose covering or any mask that does not meet the requirements of a medical device or personal protective equipment. It can therefore be worn in the same situations as a self-sewn mask. However, it may not be worn in situations where a medical mask or personal protective equipment is required. The reason for this is the unproven effectiveness of the airflow dissipation.

 

However, there are not only innovations in the field of masks, which will be particularly appreciated by deaf people, fair organizers or cultural events. 

Inventiveness was also awakened in the area of testing for the normative specifications.

 

For example, there are new testing approaches regarding quality control of medical masks or FFP masks. As a matter of principle, these masks must comply with the requirements defined at the beginning and fulfil related test requirements. In order to guarantee this throughout, a German-Israeli company, for example, has now made its autonomous machine system fit for use in this area. INSPEKTO GMBH also offers its AI system for the quality control of masks such as FFP masks and also supports new entrants to the field of compliant products.

 

However, not only the quality control of each product is relevant for the achievement of conformity. Processes such as consistent biological assessment also need to be followed for conformity with the requirements. This is where Hohenstein Laboratories GmbH & Co KG, renowned for its textile testing, has also expanded its range of services and now offers a broader portfolio of relevant tests: For example, surgical masks are tested in accordance with the European standard EN 14683 for their bacterial filter performance and the differential pressure as an indicator of breathability. In addition, the microbiological purity of the product can be assessed in accordance with ISO 11737-1 and cytotoxicity can be tested using ISO 10993-5, i.e. how skin-friendly the material of a mouth and nose protector is. In the case of masks which also have a splash guard, Hohenstein Laboratories GmbH & Co KG also carries out a test for penetration using synthetic blood in accordance with ISO 22609. In the case of washable face masks (reusable masks), functionality can be tested by re-testing after defined reprocessing cycles have been carried out.

All these are partial aspects of a successful conformity assessment procedure in order to be able to successfully place a mask on the market or to ensure the best possible protection for a community mask. Do you also have new ideas for the production, testing or implementation of masks? Then you are welcome to contact us. Because in the last step - the conformity assessment procedure - we can support you competently thanks to our many years of experience. 

 

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Please also note that the evaluation of the different masks described is based on German regulations. In other countries other classifications and regulations may apply.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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