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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

Status
Date
Type
Name
01.10.2021
Main
03.01.2017
Main
EVS-EN 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 translation of text, this information can be provided as symbols that have a specific meaning.

EVS-EN 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 who 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 a number of 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.
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