DS/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)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
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Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


Legislation

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 

Links

Scope

This document 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 are marked on the medical device itself, placed on its packaging or placed in the
associated accompanying information. The requirements of this document are not intended to apply to
symbols specified in other standards.


Number of pages: 68

Published: 2021-10-07

Date of approval: 2021-10-07

International relationships : EN ISO 15223-1:2021 IDT ISO 15223-1:2021 IDT

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

Item number: M339320


Committees

Committee

  • CENCLC/JTC 3
  • ISO/TC 210
  • ISO/TC 210/WG 3

Danish committee

DS/S-257