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EN ISO 15223-1:2021 Standard

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  Keywords:

#symbols #specific #medical #can #device

This standard can be totally or partially supervised by:
  •   EN ISO 15223-1:2021/A1:2025
  •   Directive

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

      Last Official Journal reference

    Monday 15th of June 2026

      Description:

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

      Purpose

    ISO 15223-1 specifies symbols used to express information supplied for a medical device. Medical device manufacturers and others in the supply chain must provide specific information on the medical device itself, as part of the packaging, or in the accompanying information. For simplicity and to avoid text translation, this information can be provided as symbols with a specific meaning. ISO 15223-1 does not specify the information that needs to be provided but does specify internationally recognized symbols for the provision of this specific information. It is intended to be used by manufacturers of medical devices that market products in countries where there are specific language requirements. These symbols allow for a consistent portrayal of information. It can also be used by consumers or end users of medical devices who draw their supplies from several sources and can have varied language capabilities. The text of ISO 15223-1:2021 has been approved in Europe as EN ISO 15223-1:2021 without any modification and it supersedes EN ISO 15223-1:2016.

      Publication

    Friday 7th of January 2022

      Cessation

    This standard will be withdrawn on 2031-06-17

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