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EN ISO 15223-1:2016 Standard

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  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 ISO 14971:2012

Medical devices Directive (93/42/EEC)

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

EN 60601-2-44:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipmen...

EN ISO 15883-4:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endo...

EN ISO 16061:2009

Medical devices Directive (93/42/EEC)

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version...

EN ISO 21534:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

EN ISO 21536:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2...

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