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About This Item

 

Full Description

SAME AS ISO 15223-1

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.

 

Document History

  1. DANSK DSF/PREN ISO 15223-1


    Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO/DIS 15223-1:2020)

    • Historical Version
  2. DANSK DS/EN ISO 15223-1

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    Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)

    • Most Recent
  3. DANSK DS/EN ISO 15223-1


    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)

    • Historical Version
  4. DANSK DS/EN ISO 15223-1


    Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. DANSK DSF/EN ISO 15223-1/FPRA11


    Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016, including corrected version 2017-03)