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kp100 ce certification face mask italy

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Face Mask Regulations and Standards in the EU: An Overview

Tobi Doeringer May 13, 2020 at 12:17 am . Do Type IIR masks need a CE mark assuming they have passed all tests? EN says the requirements on the packaging are ‚only‘: Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied.

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ECM_OCT_EN14683:2005

In the test in question the “Disposable Medical Face Mask” was tested. The standard tested for the product (EN 14683:2005) was confirmed after successful completion. From page 3 of the test report, you can see exactly which tests were carried out.

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