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EVS-EN ISO 15223-1:2021

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

General information

Valid from 01.10.2021
Base Documents
ISO 15223-1:2021; EN ISO 15223-1:2021

Standard history


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.

Required fields are indicated with *

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