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MEDICALDEVICESYMBOLS @IVD MANUFACTURING

Medical Device Symbols to be used with medical device labels when supplied. These symbols are a part of the regulatory requirements by leading regulatory bodies.


Purposes of labeling and symbols To identify the medical device and its manufacturer, to communicate safety and performance-related information to the user, professional or lay—these are the primary purposes of having labels on the products.

Applicable Harmonised Standards
EN 1041:2008: Information supplied by the manufacturer of medical devices.
EN 15986:2011: Requirements for labeling of medical devices containing phthalates.
EN ISO 3826-2:2008: Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets.
EN ISO 15223-1:2012: Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.


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#adsivdmanufacturing


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