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
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!!
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):
für Eich- und Vermessungswesen, Arltgasse
35, 1160 Wien, Email: firstname.lastname@example.org 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
costs and test duration, please contact the test center of your choice.
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: email@example.com)
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
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..
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): firstname.lastname@example.org.