Medical Device Labeling Symbols

Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. Manufacturer indicates the medical device manufacturer. The final rule permits the use of symbols in all medical device labeling without adjacent explanatory text referred to as stand alone symbols if certain requirements are met.

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Symbol glossary definitions symbol standard reference standard title symbol title explanatory text en 980 clause 5 12 symbols for use in the labelling of medical devices.

Medical device labeling symbols.

If your company manufactures medical devices medicines or medical related equipment you will definitely need the en iso 15223 1 medical symbols for labelling your products worldwide. General device labeling 21 cfr part 801 use of symbols. Iso 15223 1 clause 5 1 1 medical devices symbols to be used with medical device labels labelling and information to be supplied. By applying these harmonized symbols you need no further textual explanation on the packaging of your product.

The use of symbols in medical device labeling final rule final rule including the requirement for a glossary only applies to symbols that are used to convey information required by or under. Iso 15223 1 medical devices symbols to be used with medical device labels labeling and information to be supplied 5 1 1 manufacturer indicates the medical device manufacturer as defined in eu directives 90 385 eec 93 42 eec and 98 79 ec.

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