Medical Device Labeling Symbols

Iso 15223 1 clause 5 1 1 medical devices symbols to be used with medical device labels labelling and information to be supplied.

Medical device labeling symbols.

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. 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. 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. General device labeling 21 cfr part 801 use of symbols.

By applying these harmonized symbols you need no further textual explanation on the packaging of your product. 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.