Manufacturers have to characterize and classify surgical face masks in type I or II in the European market and in level 1, 2 ot 3 for the American market. Evaluation of surgical masks in Europe. In Europe, surgical masks must wear a CE mark and comply with the requirements defined in EN 14683Medical face masks Requirements and test methods.
The CE marking must consist of the initials "CE", both letters should have the same vertical dimension and be no smaller than 5mm (unless specified differently in the relevant product requirements). If you wish to reduce or enlarge the CE marking on your product, you should respect the
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Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. These rules address the size and location of the marking, affixing the CE Marking to products, packaging and material or documents shipped with the product, and specific limitations on when and who is permitted to affix the CE Marking.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Oct 08, 2012 · 6. Placing the CE marking on your product and EC Declaration of Conformity. The CE marking must be placed on the product by the manufacturer, or by
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