Full Description BS EN 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.
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.
Cross References:
ISO 7000
ISO 8601
ISO 15223-2
93/42/EEC
90/385/EEC
98/79/EC
ISO 3864-1
ISO 7010
ISO 14971
ISO 18113-1
ISO 18113-2
ISO 18113-3
ISO 18113-4
ISO 18113-5
IEC 60417
IEC 80416-1
IEC 80416-3:2002
EN 556-1:2001
EN 1041
GHTF/SG1/N43:2005
All current amendments available at time of purchase are included with the purchase of this document.
BS EN ISO 15223-1:2016 history
1970BS EN ISO 15223-1:2021 Medical devices. Symbols to be used with information to be supplied by the manufacturer. General requirements
1970BS EN ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
2017BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied-General requirements
2012BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
2008BS EN 980:2008 Symbols for use in the labelling of medical devices
2003BS EN 980:2003 Graphical symbols for use in the labelling of medical devices
1997BS EN 980:1997 Graphical symbols for use in the labelling of medical devices