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Testing of Medical Face Masks - Hohenstein

Medical face masks in the EU require a CE mark (certification). In accordance with EN 14683, the test report from Hohenstein may be used as one of the technical documents required for EU medical product certification. Other comprehensive tests and clinical evaluations are also required for approval.

Testing of medical face masks - Hohenstein

The test report on the passed test according to EN 14683 is a necessary prerequisite for this. This means that if a manufacturer would like to continue to advertise and sell medical face masks after the end of the current COVID-19 situation, they must continue their approval process to obtain a certified medical

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Surgical masks Requirements and test methods

2018-10-16 · The surgical mask shall not disintegrate, split or tear during intended use. 5.1.2 Design The surgical mask shall have a means by which it can be fitted closely over the nose, mouth and chin of the wearer and which ensures that the mask fits closely at the sides. 5.2 Performance requirements 5.2.1 Bacterial filtration efficiency (BFE)

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2020-8-13 · N95 respirators and surgical masks are examples of personal protective equipment that are used to protect the wearer from airborne particles and from …

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N95 Respirators, Surgical Masks, and Face Masks | FDA

2020-8-13 · N95 respirators and surgical masks are examples of personal protective equipment that are used to protect the wearer from airborne particles and from …

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Surgical Masks - Premarket Notification [510(k ...

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Mask Protection Standards & Medical Face Mask

A medical face mask is considered to be contaminated once it has been used, and should be discarded immediately. A mask should be removed by the edges or the ties rather than the front panel. As part of Personal Protective Equipment (PPE), medical face masks with integrated visors are recommended to ensure compliance with eye protection.