BAS EN ISO 15223-1:2022
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
General Information
Status: Published
No. of pages: 58
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 13.07.2022
Technical committee:
Directive:
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;
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
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
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 15223-1:2021, identical
- ISO 15223-1:2021, identical