Medical Device Packaging Label Icons

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.

Medical device packaging label icons.

In june of 2016 the fda issued a final rule use of symbols in labeling which allows for the use of symbols in all medical device labeling without additional explanatory text the move was made in an effort to align the u s. Iso 15223 1 clause 5 4 5. The final rule. Medical devices symbols to be used with medical device labels labelling and information to be supplied.

Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. Or mechanical environmental or packaging indicators among other purposes. Symbols were derived from iso 15223 medical devices symbols to be used with medical device labels labelling and information to be supplied council directive 93 42 eec of 14 june 1993 concerning medical devices. Device labeling requirements for symbols with international requirements.

Symbols are graphic icons used on medical devices as warnings. The international standard symbols selected to be used with medical device labels are listed in iso 15223 1 2016 medical devices symbols to be used with medical device labels labelling and information to be supplied part 1. En 980 clause 5 23. Iso 15223 1 medical devices symbols to be used with medical device labels labeling and information to be supplied 5 2 8 do not use if package is damaged.

Medical device marking and labeling. General device labeling 21 cfr part 801 use of 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. This document includes visual examples of the symbols themselves along with their.

If the medical device or ivd medical device is intended by the manufacturer for single use only reuse on a single patient and or reuse on more than one patient the label should indicate this. Iec 60601 1 uses the terms identification marking and accompanying documents to denote written text labels and symbols.