DS/EN ISO 15223-1:2016 ( Withdrawn )

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)


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 86.06
Legislation:

Legislation

Harmonized under:
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

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.


Number of pages: 46

Published: 2017-01-11

Date of approval: 2016-12-05

Date of withdrawal: 2021-10-07

International relationships : EN ISO 15223-1:2016 IDT ISO 15223-1:2016 IDT

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

Item number: M298396


Committees

Committee

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

Danish committee

DS/S-257