Medical Device Packaging Label Icons

Symbol indicating that the product packaging is able to be recycled.

Medical device packaging label icons.

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. 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. The final rule. Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.

Medical device marking and labeling. 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. 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. Iec 60601 1 uses the terms identification marking and accompanying documents to denote written text labels and symbols.

Or mechanical environmental or packaging indicators among other purposes. Iso 15223 1 clause 5 4 5. Symbols are graphic icons used on medical devices as warnings. Device labeling requirements for symbols with international requirements.

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. 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. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.

This document includes visual examples of the symbols themselves along with their. Imdrf draft on principles of labelling for medical devices and ivd medical devices grrp wg pd1 n52.