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

ISO-15223-1 - 4TH EDITION - CURRENT
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This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.

These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

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Notes

Claudia's Notes:
This part of ISO 15223 constitutes a technical revision of both ISO 15223-1:2007 and EN 980:2008, combining the symbols and requirements of both standards for the first time. There has been a steady convergence of the symbol requirements in ISO 15223-1 and EN 980 over recent years, with many of the previous differences between the standards resolved.  Users of EN 980, “Symbols for use in the labelling of medical devices,” will want to upgrade to EN ISO 15223-1, 2012 Edition, as the EN 980 is now withdrawn and obsolete.

To find similar documents by classification:

01.080.20 (Graphical symbols for use on specific equipment Standards included in this group shall also be included in other groups and/or sub-groups according to their subject)

11.040.01 (Medical equipment in general)

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Document Number

ISO 15223-1:2021

Revision Level

4TH EDITION

Status

Current

Publication Date

July 1, 2021

Committee Number

ISO/TC 210