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SSH EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

Mar 30, 2017
95.99 Withdrawal of Standard   Aug 29, 2022

General information

95.99     Aug 29, 2022

DPS

DPS/KT 316

European Norm

01.080.20     11.040.01  

English  

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Scope

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.
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.
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.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 15223-1:2012

NOW

WITHDRAWN
SSH EN ISO 15223-1:2016
95.99 Withdrawal of Standard
Aug 29, 2022

REVISED BY

PUBLISHED
SSH EN ISO 15223-1:2021

Related project

Adopted from EN ISO 15223-1:2016

Adopted from ISO 15223-1:2016