Testing Respiratory Masks

The corona pandemic is keeping the world on tenterhooks. Respiratory masks offer protection against the corona virus. DEKRA takes a close look at them in Europe’s largest test laboratory for masks in Essen.

FFP respiratory masks are tested in the DEKRA laboratory in Essen. Photo: Thomas Kienzle

FFP respiratory masks are tested in the DEKRA laboratory in Essen. Photo: Thomas Kienzle

The call for masks was loud at the beginning of the corona crisis. Upon recommendation of the EU Commission, the Markets Authority cleared the way for a corona pandemic respiratory mask (CPA) rapid test. Masks that hadn’t undergone the EU Conformity Assessment Procedure came onto the German market as an exception at the beginning of the pandemic. The goal was to avoid bottlenecks. Manufacturers and importers were meant to be able to place protective masks on the market with a minimum level of safety during the corona pandemic’s first phase. On the basis of this recognized rapid test, DEKRA tested masks in its special laboratory. From March to September, the expert organization targeted products from 1,500 manufacturers. 80 percent of the tested masks didn’t meet the test criteria and, according to DEKRA, should not have been put on sale. The expert organization estimates that there are currently eight billion masks in circulation in Germany, but only four billion have been tested. As of October 1, 2020, the CPA rapid test is no longer possible, following the Markets Authority’s decision. From this date on, only FFP masks that have undergone the complex EU Conformity Assessment Procedure and bear the required CE label are marketable. At the DEKRA test laboratory, experts take a close look at FFP2 and FFP3 masks.

Tests in three-shift operation

Whereas before the pandemic three to four mask models were tested per year according to the EN149, the number has risen to as many as 30 mask models per month. And the demand for testing is high. DEKRA now works in three shifts, and three other test laboratories in Stuttgart, Dresden, and Bochum are involved in parts of the testing.
The procedure for the CPA rapid test took about three and a half days. In “normal times”, DEKRA estimates 150 hours for a complete approval procedure for an FFP2 mask. “However, since we’ve switched to shift operation, we can ideally complete a round of testing in one and a half weeks,” explains Jörg-Timm Kilisch, Managing Director of DEKRA Testing & Certification. An important test criterion is the flow-through test. Since there are different protection classes, the limit values for the permeability of aerosols also differ. For an FFP1 mask, the limit value is 20 percent. For an FFP2 mask, it’s less than six percent. An FFP3 mask may allow less than one percent of aerosols to pass through in both directions.

Jörg-Timm Kilisch, Managing Director DEKRA Testing & Certification. Photo: Thomas Kienzle

Jörg-Timm Kilisch, Managing Director DEKRA Testing & Certification. Photo: Thomas Kienzle

Three questions for Jörg-Timm Kilisch, Managing Director DEKRA Testing & Certification

Mr. Kilisch, can so-called CPA protective masks, which were put on the market via the accelerated testing procedure between March and the end of September 2020, continue to be distributed and used?
Corona pandemic respirator  masks remain safe to use for the stated purpose until the end of their expiration date – including for employers – and are marketable in Germany according to the Central Office of the Federal States for Safety Technology (ZLS). The dealer proves this with a test report from the recognized test institute and a certificate of marketability from the Markets Authority. Apart from this, an FFP2 mask offers the greatest external and self-protection.

How can you recognize a marketable FFP2 or FFP3 protective mask?
FFP2 and FFP3 protective masks bear a CE label with a four-digit identification number. At DEKRA, for example, it is “CE 0158”. They’ve undergone the EU Conformity Assessment Procedure in accordance with PPE Regulation (EU 2016/425) and meet the requirements of EU Standard EN 149.

How can an employer ensure that FFP2 or FFP3 masks for its employees meet the legal requirements?
The dealer, importer, or manufacturer must provide proof that the FFP mask model has successfully undergone the EU Conformity Assessment Procedure – i.e. CE label and EU Declaration of Conformity. Ideally, he can present the EU Type Examination Certificate from the recognized test institute.

CE label: FFP respiratory masks bear the CE label if they pass the conformity assessment procedure according to the PPE Regulation (EU 2016/425) and meet the requirements of European Standard (EN) 149 test specifications. Filter performance and the mask’s tightness are tested among other things. The testing and certification body is identified by the 4-digit number after the CE. Masks tested by DEKRA bear the CE 0158 label.

N95 label: This standard meets the N95 air filtration rating standard of the US National Institute for Occupational Safety and Health (NIOSH). This means that at least 95 percent of airborne particles must be filtered. The letter N indicates that the mask isn’t resistant to oily aerosols, unlike the P95 mask.

P2 label: The AS/NZS 1716-2012 Respiratory protective devices is a common standard of Australia and New Zealand. It essentially meets the requirements of FFP2 masks. Masks produced in accordance with this standard must be labelled on the mask or on the packaging.

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