CEN - EN ISO 15223-1
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
|Publication Date:||1 November 2016|
|ICS Code (Graphical symbols for use on specific equipment):||01.080.20|
|ICS Code (Medical equipment in general):||11.040.01|
This document identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
This document is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.