Abstract

This document identifies requirements for symbols used in medical device labelling that may convey information on the safe and effective use of medical devices. The Amendment includes the addition of defined term for authorized representative (clause 3.20), modified EC REP symbol to not be country or region specific (Item 5.1.2 in Table 1 and A.4 in Annex A)

Begin

2023-01-04

WI

JT003073

Planned document number

DIN EN ISO 15223-1/ A1

Project number

06302196

Responsible national committee

NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices  

Responsible european committee

CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices  

Responsible international committee

ISO/TC 210/WG 3 - Symbols and nomenclature for medical devices  

draft standard

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1 (ISO 15223-1:2021/DAM 1:2024); German and English version EN ISO 15223-1:2021/prA1:2024
2024-06
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previous edition(s)

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021); German version EN ISO 15223-1:2021, with CD-ROM
2022-02

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