Medical Device Packaging Label Icons

This document includes visual examples of the symbols themselves along with their.

Medical device packaging label icons. En 980 clause 5 23. 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. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. 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. Medical devices symbols to be used with medical device labels labelling and information to be supplied.

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. General device labeling 21 cfr part 801 use of symbols. Device labeling requirements for symbols with international requirements. The final rule.

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. 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. 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 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.

Imdrf draft on principles of labelling for medical devices and ivd medical devices grrp wg pd1 n52. Iso 15223 1 clause 5 4 5.