EN ISO 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

General information

Current stage: 60.60 Standard published Sep 29, 2021

Originator: CEN/CENELEC

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

Type: European Norm

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

Scope

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.

Related legislation

Legislation related to this standard

2017/745

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/EEC

Harmonized/Supporting

Legislation 2017/745

2017/746

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/EU

Harmonized/Supporting

Legislation 2017/746

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15223-1:2016

NOW

PUBLISHED
EN ISO 15223-1:2021
60.60 Standard published
Sep 29, 2021

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
EN ISO 15223-1:2021/prA1