ISO 15223-1:2021

ISO 15223-1:2021

July 2021
International standard Current

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

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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Main informations

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International ISO standards

Publication date

July 2021

Number of pages

36 p.

Reference

ISO 15223-1:2021

ICS Codes

01.080.20   Graphical symbols for use on specific equipment
11.040.01   Medical equipment in general

Print number

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

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.

Replaced standards (1)
ISO 15223-1:2016
November 2016
International standard Cancelled
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

<p>ISO 15223-1:2016 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.</p> <p>ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.</p> <p>These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.</p>

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