Medical Device Packaging Label Icons
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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 packaging label icons. Medical device marking and labeling. Iec 60601 1 uses the terms identification marking and accompanying documents to denote written text labels and symbols. General device labeling 21 cfr part 801 use of symbols. 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.
Medical devices symbols to be used with medical device labels labelling and information to be supplied. Symbol indicating that the product packaging is able to be recycled. Or mechanical environmental or packaging indicators among other purposes. 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. 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. Imdrf draft on principles of labelling for medical devices and ivd medical devices grrp wg pd1 n52. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.
En 980 clause 5 23. Device labeling requirements for symbols with international requirements. This document includes visual examples of the symbols themselves along with their. 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. The final rule.
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