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EN ISO 15223-1:2016 Standard

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  Keywords:

#symbols #document #version #may #packaging

  Directive

Active implantable medical devices Directive (90/385/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 2016-12-15)

  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 ISO 10993-13:2010

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medic...

EN ISO 13408-4:2011

Active implantable medical devices Directive (90/385/EEC)

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

EN ISO 11137-2:2015

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

EN ISO 10993-17:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 13408-6:2011

Active implantable medical devices Directive (90/385/EEC)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 10993-4:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

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