60.60 Standard published Sep 29, 2021
CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices
01.080.20 Graphical symbols for use on specific equipment | 11.040.01 Medical equipment in general
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EECHarmonized/Supporting
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EUHarmonized/Supporting
EN ISO 15223-1:2016
EN ISO 15223-1:2021
60.60 Standard published
Sep 29, 2021
EN ISO 15223-1:2021 prA1