The problem

If the problem of adequately protecting the population with masks at the beginning of the pandemic was that there were simply not enough masks available and, in particular, that there was insufficient domestic production, later quality and

Admission of the masks in the foreground of the criticism.

The lack of masks had meant that products were temporarily placed on the market, some of which were certified according to standards other than European, some of which did not meet any quality standard at all, and in numerous cases were also incorrectly labeled.

In the second wave, there were Corona regulations, according to which only so-called medical masks were allowed. Officially, this means either the so-called FFP2 masks or surgical or surgical masks. While the former offer good protection for the wearer with appropriate quality according to consistent scientific findings, surgical or surgical masks actually protect primarily the environment and not the wearer himself.

It is now generally established that the aforementioned, preferred FFP2 masks require approval that requires the involvement of a certification body. The consumer recognizes this from the CE mark, followed by a 4-digit mark, which allows conclusions to be drawn about the certification body.

So far so good.

In the meantime, however, there are increasing reports that even certified FFP2 masks only provide limited protection against infection by the corona virus. This is the only way to explain numerous infections, for example from employees who are employed in nursing homes or Covid wards. The reason for this phenomenon is the fact that although certain filter media hold back large aerosol droplets, small aerosols and / or viruses can easily pass through the filters. In addition, the measurement methods described in the EN 149 standard cannot reliably determine an inadequate filter effect of the smallest aerosol droplets.

Measurements have shown, however, that this problem does not exist in the same way with all FFP2 masks. There are considerable differences in quality between the individual models here - the consumer is helpless, however, as he cannot in any way recognize which masks offer adequate protection despite certification and which do not.

In addition, manufacturers located abroad, in particular, are usually unable to provide evidence of an established quality management system. For approval, a mask is checked once by a certification body (which is usually also located abroad), then the CE mark is awarded, but an ongoing and, above all, continuous quality check is no longer carried out afterwards.

The realization

In order to actually ensure consistent, continuous protection for the wearer of an FFP2 mask, the existing standard, which was originally created for protective work masks for the trade, should urgently be modified. In many cases, the instructions for use of these masks even contain information that they do not protect against viruses.

However, this statement is not tenable. On the one hand, the viruses are sometimes found in tiny aerosol particles that can easily get stuck in the filter of a high-quality FFP2 mask; on the other hand, there are actually masks available on the market that can even hold back individual viruses with sizes between 80 and 120 nm.

What is needed, however, is a test method that is suitable for objectively determining the properties of the filters mentioned above.

The good news: For example, with the PMFT 1000 developed by the Palas company, such a worldwide unique measuring device is available. The test procedure is already used regularly by some manufacturers for quality control, it also corresponds to the EN 149 standard. And these measurements are not only made once when the respective products are approved, but continuously, ie for each batch and regularly after the change in production Raw materials running.

In this situation, the obvious thing to do would be to change the decisive standard EN 149 as quickly as possible, with the aim of continuously monitoring both product quality and the manufacturing process. Unfortunately, however, it can be assumed that the change in the standard, due to the fact that various international institutes and authorities would have to be involved, will probably only be implemented when the corona problem is a thing of the past.

The solution

After Dipl.-Ing. Dr. med. Roland Ballier has been involved in the above-mentioned problem in his function as a publicly appointed and sworn expert for months, the realization has grown that only a quickly available, forgery-proof quality label that addresses the above problem is suitable for the consumer to provide the necessary security when choosing a high-quality mask.

The newly designed label bears the name

CCF - Covid Certified Filter

The quality label

The manufacturer / sales organization is given the right to attach the quality label to the outside of the mask, provided that it meets all the requirements of the certification body. If the obligations, which include the regular submission of corresponding quality certificates, in particular control measurements, are violated, the label will be withdrawn.

The label is supplemented by a sequential number that allows conclusions to be drawn about the manufacturer and the batch.