Medical Device Packaging Label Icons

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

Medical device packaging label icons.

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 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. Symbol indicating that the product packaging is able to be recycled. General device labeling 21 cfr part 801 use of symbols.

Device labeling requirements for symbols with international requirements. Medical device marking and labeling. 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. The final rule.

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. En 980 clause 5 23. 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.

Symbols are graphic icons used on medical devices as warnings. 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. 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 devices symbols to be used with medical device labels labelling and information to be supplied.

Imdrf draft on principles of labelling for medical devices and ivd medical devices grrp wg pd1 n52. 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.