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Area of application: Working in areas with an increased risk of infection in the health sector and in nursing and CPA (Corona SARS-Cov-2 pandemic respiratory protection masks)
In the event of suspected or confirmed COVID-19 disease, the supervising / examining person should wear an FFP2 or FFP3 respiratory mask, hood, gloves, protective clothing and protective goggles, depending on the activity. These are respiratory masks that are subject to the provisions of Regulation (EU) 2016/425.
In the case of personal protective equipment (PPE) of category III (risk of serious consequences such as death or irreversible damage to health according to Annex I of Regulation (EU) 2016/425), the manufacturer of these respiratory masks has to undergo an EU type test (module B) and also to subject the production of this PPE to monitored product tests (module C2) or to a quality assurance system for the production process (module D), to issue an EU declaration of conformity for this PPE and to affix a CE mark to every respirator.
Due to the COVID-19 threat, due to the dramatically increased need for and to avoid bottlenecks in respiratory masks, the Federal Minister for Digitization and Business Location (BMDW) decreed April 3, 2020, GZ 2020-0.198.830, to accelerate the procedure so that Through a shortened evaluation procedure and based on a positive test result, a so-called "Cov-2 virus pandemic respirator mask (CPA)" can be made available to medical professionals for the duration of the current health threat even without the CE mark being attached.
You have the option of having this shortened assessment procedure (i.e. the specific material test) carried out by the physical-technical testing service (PTP) of the Federal Office for Metrology and Surveying. In this regard, the PTP / BEV acts in accordance with Art. 26 Paragraphs 2 and 3 of Regulation (EU) 2016/425.
The ÖTI, as a notified conformity assessment body, can then issue a corresponding certificate for the "Cov-2 Virus Pandemic Respirator (CPA)" on the basis of a positive test report from the PTP / BEV, i.e. after a positive material test has been passed.
Contacts and process:
Commissioning of testing of the masks according to the shortened procedure in accordance with the "Test principle for Corona SARS-Cov-2 Pandemic Respiratory Protection Masks (CPA) Rev. 0 of March 20, 2020" at the test center named in Decree 2020-0.198.830-1-A.
Testing center for CPA in Austria
Physical-technical inspection service (PTP)
Federal Office for Metrology and Surveying (BEV)
Tel: +43 1 21110 826325
Email: [email protected]
The PTP / BEV will send you and, if you commission this, also the ÖTI as a notified conformity assessment body, the test report on the material test (as a PDF). In this regard, the ÖTI, as a notified conformity assessment body, is responsible for the PTP // BEV within the meaning of Articles 26 and 24 of Regulation (EU) 2016/425 on personal protective equipment.
The costs for an examination - shortened procedure Corona SARS-Cov-2-Virus pandemic respiratory protection masks (CPA) without exhalation valve amount to € 1,308.00 (excluding 20 percent VAT). For each batch to be checked, the PTP / BEV requires a material quantity of 40-50 pieces of masks.
After a positive test report is available:
Commissioning of the assessment in accordance with the "test principle for corona virus pandemic respiratory protection masks (CPA)" at the certification body ÖTI - Institute for Ecology, Technology and Innovation GmbH, Spengergasse 20, 1050 Vienna, email: [email protected]
Evaluation costs: € 934.00 (excluding VAT)
For the purpose of verifiability and documentation, the ÖTI - Institute for Ecology and Innovation GmbH requires a quantity of five to ten masks for each batch tested. These can be made available to the ÖTI as a notified conformity assessment body on your behalf by the PTP / BEV.
The corona virus pandemic respiratory protection masks (CPA) evaluated according to the shortened procedure are not personal protective equipment according to Regulation (EU) 2016/425 and do not receive a CE mark.
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