EN ISO 15223-1:2012

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

Publication date:   Jan 22, 2013

General information

99.60 Withdrawal effective   Nov 30, 2016

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

Buying

  Withdrawn

PDF - €50.63

  Bulgarian   English  



Buy

Scope

ISO 15223-1:2012 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 ISO 15223-1:2012.
ISO 15223-1:2012 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 ISO 15223-1:2012 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

90/385/EEC

Active implantable medical devices

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 980:2008

NOW

WITHDRAWN
EN ISO 15223-1:2012
99.60 Withdrawal effective
Nov 30, 2016

REVISED BY

WITHDRAWN
EN ISO 15223-1:2016