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EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03) EN ISO 15223-1:2016

Publication date:   Feb 16, 2017

General information

99.60 Withdrawal effective   Sep 29, 2021

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

01.080.20   Graphical symbols for use on specific equipment | 11.040.01   Medical equipment in general

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Scope

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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
more
93/42/EEC

Medical devices

Harmonized/Supporting
more
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
more

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15223-1:2012

NOW

WITHDRAWN
EN ISO 15223-1:2016
99.60 Withdrawal effective
Sep 29, 2021

REVISED BY

PUBLISHED
EN ISO 15223-1:2021