Need help?

EN ISO 15223-1:2016 Standard

wave
Save  

  Keywords:

#symbols #document #corrected #may #packaging

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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)

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 980:2008"

Anyway is still possible use the "EN 980:2008" until December 31st, 2017

  Related Standards

EN 1641:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Materials

EN ISO 11810-2:2009

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-pro...

EN ISO 5840:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

EN ISO 7396-1:2007

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

EN ISO 7396-1:2007/A1:2010

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

EN ISO 7396-1:2007/A2:2010

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 15223-1:2016 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0