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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.

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2020-4-15 · Clause Requirement - Test Result - Remark Verdict According to the definition and classification in EN ISO 10993- 1, a medical face mask is a surface device with limited contact. The manufacturer shall complete the evaluation of the medical face mask according to EN ISO 10993- 1 and determine the applicable toxicology testing regime.

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