Test + certify respirators
EU-type examination, certification and quality assurance tests
Due to the Corona pandemic, there is currently an increased need for respirators. ift Rosenheim is accredited according to EN ISO/IEC 17025 and offers as notified body according to the PPE Regulation (EU) 2016/425 type tests as well as certifications for these masks (e.g. FFP2). In addition, independent quality assurance tests can be carried out based on EN 149 and the CPA testing principle.
Contact us – Our test equipment is ready for your masks!
Testing and certification of FFP1, FFP2 and FFP3 masks
ift Rosenheim is notified as a testing and certification body for respiratory protective devices as well as filtering half masks with/without valves according to EN 149. This allows your particle filtering half masks (FFP1, FFP2 and FFP3) to be tested, certified and monitored.
Respirators are classified in risk category III of the PPE Regulation (EU) 2016/425. Therefore, in addition to the EU-type examination (Module B/Annex V), one of the following modules is required as a prerequisite for CE marking:
- Module C2/Annex VII: Internal production control with monitored product tests at irregular intervals by ift Rosenheim (as notified body)
- • Module D/Annex VIII: Quality assurance system for the production process, monitored by ift Rosenheim (as notified body)
Then, the manufacturer can affix the CE marking.
The test rigs used were largely developed and produced by our subsidiary ift MessTec GmbH. Please feel free to contact us if you are interested in individual test rigs! !
Quality assurance of respirators
In order to prove the quality of the masks you have purchased or to check the consistent product quality, ift Rosenheim offers a test based on EN 149 or the CPA testing principle. Quality assurance can be performed completely or on individual characteristics, such as the filter penetration. We will be pleased to compile an individual test plan for you.
This enables clients (e.g. hospitals, consumer protection, associations or authorities) to independently and impartially ensure the consistent product quality of the respirators they use and to create lasting confidence in the product among end users. The tests are made within a few days and you will receive a qualified test result for your respirators at short notice.
More information on this is available in the “Test methods for quality assurance” (available in German)
Is your product eligible for testing?
Please check if your product is eligible for the quick test before contacting ift Rosenheim. Information on the distinction between product types can be found here:
- Recommendations for the use of self-made masks (Federal Institute for Drugs and Medical Devices - BfArM - available in German)
- Distinction between mouth/nose protection and particle-filtering respirator (Bavarian State Office for Health and Food Safety - available in German)
- Protective masks FFP2 and KN95 are comparable with each other (DIN e. V. - available in German)
- Act on making products available on the market (Produkct Safety Act - ProdSG - avialable in English)
- The marketability of personal protective equipment in the Federal Republic of Germany is determined by the responsible market surveillance authority. You can search for the market surveillance authority responsible for you via this link (for Regulations: Regulation on Personal Protective Equipment).
Kontakt
Stephan Rauscher
Projektkoordination
atemschutz@ift-rosenheim.de +49 (0)8031 261-0 +49 (0)8031 261-290Wichtige Informationen - kurz & knapp
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The technical test duration including documentation is 5 to 7 working days for quality tests and approx. 14 days for a type test according to EN 149
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We will be pleased to discuss the number of test specimen and the next steps with you personally.
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Please do not send us masks without being asked!
Interesting links:
- Nando listing of ift Rosenheim
- PPE Regulation (EU) 2016/425
- Testing principle for Corona SARS-Cov-2 pandemic respirators Rev. 02 dated 02.06.2020 - German
- Testing principle for Corona SARS-Cov-2 pandemic respirators Rev. 01 dated 26.03.2020 (informative) - German
- Testing principle for medical face masks Rev. 0 dated 14.04.2020 - German
- Press release on the topic - German