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SSH 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)

Aug 29, 2022

General information

60.60     Aug 29, 2022

DPS

DPS/KT 316

European Norm

01.080.20     11.040.01  

English  

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Scope

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.

Related directives

Directives related to this standards.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized
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Life cycle

PREVIOUSLY

Replaces
SSH EN ISO 15223-1:2016

NOW

PUBLISHED
SSH EN ISO 15223-1:2021
60.60 Standard published
Aug 29, 2022

Related project

Adopted from EN ISO 15223-1:2021

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