Information for interested parties referring to tests of Coronavirus pandemic respiratory masks (CPA)

Testing Corona Virus Pandemic Respiratory Protection Masks (CPA) DEKRA

Problem:

At present the availability of respiratory protection masks on the German market is insufficient to meet the demand of the people with regard to infection protection. To remedy this situation, inventories and protection masks which have no CE certificate (e.g. of manufacturers which have not produced PPA until now or imported masks) shall be made available for the market. Therefore the German Federal Government has enacted the Regulation for the security of supply with medical requirements (MedBVSV) on the basis of the German Infection Protection Act. Thus, the market surveillance authorities control the marketability of so-called Corona pandemic respiratory protective masks (CPA) on the basis of § 9 MedBVSV.

Simplified test procedure:

To draw up the minimum requirements with regard to suitability in infection protection, the Central Office of the Federal States for Safety Engineering (ZLS) requested several German test institutes to develop a new test principle that describes the minimum requirements for Coronavirus pandemic respiratory protective masks (CPA). This new test principle is based on the test principle revision 1 that had been established according to EU recommendation (EU) 2020/413 and was released by the ZLS on 20 March 2020. The new version of this testing principle (revision 2) has been released by the ZLS on 2 June 2020.

You can download the test principle, revision 2, here:

Details of the procedure:

This procedure does not depict a certification of CPA! The listed testing institutes (which act solely as testing laboratories) will test masks according to this test principle and create a test report and an assessment letter. This letter will be sent to the ZLS, which will inform the market surveillance authorities that they can declare the marketability for the masks that have passed the test. This may hold until the end of the pandemic, although these masks have not passed an EU conformity assessment procedure.

Main differences from the first testing principle:

The legal basis for the new testing principle is the MedBVSV. The legal basis for the new testing principle is the MedBVSV. Acc. to paragraph 2.7 of the testing principle a CPA mask must be market as such only. Therefore, any variant of misleading marking, e.g. FFP 2 or FFP 3, a hint to EN 149 or a CE mark is not allowed now, neither on the mask nor on the packing. We ask you please to check if your masks or the packing show any marking which is forbidden acc. to paragraph 2.7 of the new testing principle before placing an order or even sending masks to us!

Paraffin oil or NaCl

The flow rate through the filter medium can be tested with paraffin oil or with sodium chloride steam (NaCl). Clients may apply for both tests, too.

Contact us:

DEKRA Testing and Certification GmbH

Handwerkstraße 15

70565 Stuttgart

Laboratory for product testing

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+49.711.7861-3454
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The purely technical duration of the test is 6 work days. Delivery times will be announced individualy.

For the testing procedure we need 3 complete packaging units from which we can take 21 samples altogether.

Please send us under no circumstances any test samples without being asked!

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