Rapid test for respiratory protective equipment for use during pandemics

Frequently asked questions

Note: Until June 22, the IFA cannot accept any more test orders.

Facility now exists for respiratory masks to undergo a rapid test to determine their suitability for protection against Sars-CoV-2. The aim: to provide a swift response to the acute shortage of products with European approval providing respiratory protection during pandemics, and to protect medical and nursing professionals for the duration of the health threat posed by the Corona pandemic.

In response to a recommendation by the European Commission issued in mid-March, the Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) and DEKRA Testing and Certification GmbH developed a rapid test for these products which meets with great interest among manufacturers and importers. In order to provide important details on the test and its conditions and to enable companies to decide for themselves whether their products are eligible in principle for the rapid test, the IFA has now published answers to frequently asked questions.

  • 1. What is the basis for the rapid test?

    With Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat, the European Commission has provided the competent authorities of the Member States with the option of purchasing respiratory masks without CE marking in an organized manner and of approving the making available of such masks on the EU market for a limited period. This arrangement is conditional upon the respiratory masks assuring an appropriate level of safety and health. In addition, the masks approved under this arrangement are to be made available solely to medical and nursing personnel for the duration of the current health threat posed by the Corona pandemic where an acute shortage of respiratory masks exists (cf. 10).

  • 2. What is covered by the rapid test?

    Details of the scope of the rapid test are described in the test specification (PDF, 417 kB):

  • 3. Who may perform the rapid test?

    All test bodies currently authorized by the ZLS (the central body of the German regional authorities with responsibility for safety technology) to perform the rapid test can be found on the website of the ZLS.

  • 4. Who may commission the testing of products?

    Manufacturers and importers who are in a position to place large numbers of respiratory masks on the market within a short space of time (50,000 respiratory masks or more within 3 weeks) may request performance of the rapid test on their products from one of the approved test bodies (cf. 3).

  • 5. What products are eligible for the rapid test?

    Only tight-fitting, high-filtration respiratory masks preferably without exhalation valve are eligible for the rapid test and thus for a possible positive technical assessment as pandemic respiratory device for use in the healthcare sector during pandemics.

    Medical devices (surgical mouth/nose masks) are not covered by this arrangement.

  • 6. How is the rapid test requested?

    The manufacturer/importer first sends a request by e-mail to the approved test body (cf. 3). Requests made to the IFA should be addressed to: . The request must contain the following information:

    • Informal request accompanied by a photograph and description of the product
    • Statement of the planned weekly production volumes
    • Statement of the intended user group, e.g. hospitals, emergency medical services

    At the test body's request, the manufacturer/importer then sends 21 type samples of the product to be tested. For testing by the IFA, samples are to be sent to:

    Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA)
    - Prüflabor Atemschutz -
    Alte Heerstrasse 111
    53757 Sankt Augustin, Germany

    The test samples may also be delivered in person, provided the hygiene requirements are complied with. An appointment must be made with the test laboratory in this case.

  • 7. How much does the test cost and how long does it take?

    The full rapid test lasts approximately two days, plus a waiting period of unspecified duration. The costs are in the order of €3,000.

  • 8. What form of document is issued to the manufacturer/importer that his respiratory mask has passed the rapid test?

    The approved test body generates a test report and, where the requirements set out in the test specification are met, also a letter of assessment. This confirms that the tested product satisfies the requirements of the test specification (cf. 2) and states a technical presumption of efficacy for the tested respiratory mask. Each letter of assessment is automatically entered into a database at the ZLS, which is used by the market surveillance authorities to check the authenticity of certificates.

    Important note: A successfully passed test including the evaluation of the test results by the IFA only does not allow to place the product on the market.

    A separate regulatory measure is still required.

    A list of the market surveillance authorities responsible for this is shwon by the ICSMS information service if "89/686/EEC - Personal Protective Equipment Directive" is selected under the search term Directive/Regulation.

  • 9. What happens to the tested respiratory masks once the 12 months have expired?

    Respiratory protective equipment for use in pandemics, the technical efficacy of which has been approved against the test specification stated under point 2, ceases to be valid after 12 months. If the product is to be distributed in the European Union as normal respiratory protective equipment in accordance with the PPE directive following expiry of this deadline, it must be:

    1. Subjected to full testing in accordance with EN 149
    2. Assessed by a notified body for its compliance with PPE Regulation (EU) 2016/425

  • 10. Respiratory protective equipment for use in pandemics and subjected to rapid testing is intended as a last resort for workers in the healthcare services. Which respiratory protection products should primarily be used?

    The ZLS (the central body of the German regional authorities with responsibility for safety technology) states the following:

    1. Respiratory masks tested and certified in accordance with the European PPE Regulation against EN 149, Particle filtering half masks. A tested and approved mask can be recognized by the CE mark followed by the four-digit code number of the test laboratory (e.g. CE0121) and reference to the standard applied, EN 149: 2001, A1: 2009, on the product and its packaging.
    2. Should products complying with a) not be available: Respiratory masks which are marketable in the United States of America, Canada, Australia or Japan, even when they do not bear CE marking or are not accompanied by a certificate of conformity or a German instruction manual. Such masks can be identified by the markings shown in a list (PDF, 352 KB) of the German Federal Institute for Occupational Safety and Health (BAuA).

  • 11. Where do (potential) manufacturers get additional information on conformity assessment of protective equipment?

    The European Commission issued guidelines for manufacturers on the internet.

    Please note: For the pandemic period, regular conformity assessement of respiratory protective equipment according to the European PPE Directive is not conducted by the IFA.

Background: Why rapid testing?

Tested respiratory protection in the DGUV certificate database

Currently, numerous respiratory protective devices with forged certificates are causing uncertainty. Whether a product has actually been tested in accordance with the standard and certified under the regulation can be researched in the DGUV Test database.