Medical Device Symbols

Medical devices symbols to be used with medical device labels labeling and information to be supplied part 1.

Medical device symbols. Graphical symbols for use on labels and instruction leaflets. Symbols to be used with medical device labels labelling and information to be supplied. These symbols have been submitted to iso international standardisation organisation and are currently being considered in the revision of iso 15223 1 medical devices symbols to be used with medical device labels labelling and. Argon s labeling is designed to meet the following standards.

Indicates the date after which the medical device is not to be used iso 15223 use by date iso grs 7000 2607 use by date. Use by date use by date. Iso international standardisation organisation 15223 2 process iso 15223 2 2010 01 medical devices symbols to be used with medical device labels labelling and information to be supplied part 2. Symbol development selection and validation.

For the purposes of this document the terms and definitions given in iso 14971 and the following apply. 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. Symbols if the device is a medical device md or in vitro diagnostic ivd. 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 council directive 90 385 eec of 20 june 1990 on active implantable medical devices and council directive.

The graphical symbols in this guidance have all been validated with users including patients and healthcare professionals according to international standards. Medical device symbols in the european union symbols for marking and labeling of medical devices and medical products en 980 2008 symbols for medical device labeling standard is withdrawn per 2 2013. 21 cfr 820 120 21 cfr 801 iso 13485 section 3 6 bs en iso 15223 1 bs en 1041 applicable sections of the canadian medical device regulation and other international standards regulations. Plastics collapsible containers for human blood and blood components part 2.

Medical devices symbols to be used with medical device labels labeling and information to be supplied part 1. Moreover for the ivd symbol it is important to mention that the symbols is to identify in vitro diagnostic devices. 3 terms and definitions.