08.04.2020

Information about test and evaluation of 

"Corona SARSCov-2 Virus Pandemic Respirators (CPA)"


In recent days, the legal basis for a rapid path to an evaluation of respiratory masks has been created with the enactment 2020-0.198.830 (from 02 April 2020). Based on this decree, a shortened procedure can be carried out in Austria. This shortened procedure enables masks without CE marking to be placed on the market in Austria (for the exclusive use of medical professionals).

The following is a brief overview of the steps required to carry out a shortened assessment procedure based on Enactment 2020-0.198.830 (dated April 02, 2020) for the placing on the Austrian market of "Corona SARSCov-2 Virus Pandemic Respirators (CPA)".

ATTENTION: for placing on the market in Austria a business partner based in Austria is required!!


Material testing

Commissioning of testing of the masks according to the shortened procedure according to "Test principle for Corona SARS-Cov-2 pandemic respirator masks (CPA) Rev. 0 from 20.03.2020" at the - in the Enactment 2020-0.198.830 (from 02. April 2020) - named test laboratory.

Test laboratory for CPA in Austria (not notified):

Physikalisch-Technischer Prüfdienst Bundesamt für Eich- und Vermessungswesen, Arltgasse 35, 1160 Wien, Email: ptp@bev.gv.at  Website: www.bev.gv.at

Important: If possible, please agree with the selected test laboratory that as soon as the test report is available, it will be sent to you and to the ÖTI (as PDF)

As far as we know, the test laboratory require 50 pieces of each type for testing. Regarding costs and test duration, please contact the test center of your choice.


Assessment

Commissioning of the evaluation in accordance with the "Test principle for corona virus pandemic respiratory masks (CPA)" at the certification body (ÖTI - Institute for Ecology, Technology and Innovation GmbH; Spengergasse 20, 1050 Vienna; email: ppe@oeti.biz)

The following documents and samples are required to commission the evaluation:

  • completed applicationform for performing a shortened assessment process (See attachement "CPA-Mask_Application for the implementation of a shortened evaluation procedure.pdf", please fill in the appropriate fields, sign them and send them as a PDF to the ÖTI)
  • completed technical documentation (See attachement "CPA-Mask_technical document.docx", this Word document serves as a template to support you. All the necessary text passages to be supplemented by you are recognizable here in red text. Please complete these text passages and, if they are okay for you, change the font colour to black. Then send it to the ÖTI as a Word document)
  • The respirator or the smallest packaging unit must be labeled with the following information: Name, trademark or other information to identify the manufacturer and Type-identical identification (number, model or similar)
  • Information must be included with every Respirator or the smallest packaging unit. The information can be presented in text form or, for example, in pictograms. The information must contain at least information: fit and correct putting on and taking off and Instructions for use
  • Test report of a test laboratory named in Enactment 2020-0.198.830 (from April 2nd, 2020) about the material tests carried out in accordance with the shortened procedure
  • Required amount of material: min. 5 - 10 Pcs. Masks


Please take note of the following guidelines

  • Masks evaluated in this way do not receive a CE marking and therefore a CE marking of the corona virus pandemic respirator masks (CPA) is not permitted
  • Corona virus pandemic respirators (CPA) based on Commission Recommendation (EU) 2020/403 of March 13, 2020 and Decree 2020-0.198.830 (April 02, 2020) without CE marking may be placed on the Austrian market only for use by medical professionals
  • The corona virus pandemic respirators (CPA) assessed according to the shortened procedure are not personal protective equipment according to regulation (EU) 2016/425..
  •  The Corona Virus pandemic respirators (CPA) are not considered equivalent to respirators that have passed a full test according to EN 149: 2001 + A1: 2009 and are based on the PSA VO (EU) 2016/425 with an EU type examination certificate (module B ) have been approved.

If you have any further questions, please send an email to our department for personal protective equipment (PPE): ppe@oeti.biz.


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