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NORM

Current

ÖVE/ÖNORM EN ISO 15223-1

Issue date: 2022 01 01

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

There are 1 addition(s) to this standard

Document Number	Title
Document Number ÖVE/ÖNORM EN ISO 15223-1/A1	Title Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific - Amendment (ISO 15223-1:2021/Amd 1:2025)

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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General information on ÖVE/ÖNORM EN ISO 15223-1

Format

Paper | 71 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖVE/ÖNORM EN ISO 15223-1 from 2017 til today.

• ÖVE/ÖNORM EN ISO 15223-1

  2022 01 01 Norm

  Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: G...
• ÖVE/ÖNORM EN ISO 15223-1

  2017 04 01 Norm

  Medical devices - Symbols to be used with medical device labels, labelling and information to be sup...

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Frequently Asked Questions about ÖVE/ÖNORM EN ISO 15223-1

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art
Dokumentnummer ISO 15223-2:2010	Titel Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation	Ausgabedatum 2010 01 15	Art Norm	Zur Produktseite
Dokumentnummer ISO 3166-1:2020	Titel Codes for the representation of names of countries and their subdivisions — Part 1: Country code	Ausgabedatum 2020 08 25	Art Norm	Zur Produktseite
Dokumentnummer ISO 8601-1:2019	Titel Date and time — Representations for information interchange — Part 1: Basic rules	Ausgabedatum 2019 02 25	Art Norm	Zur Produktseite
Dokumentnummer ISO 8601-2:2019	Titel Date and time — Representations for information interchange — Part 2: Extensions	Ausgabedatum 2019 02 25	Art Norm	Zur Produktseite

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