ISO 15223-1:2016 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.
ISO 15223-1:2016 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.
Status: WithdrawnPublication date: 2016-11
Corrected version (en): 2017-03
Corrected version (fr): 2017-03
Edition: 3Number of pages: 25
Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices