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STANDARD

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ÖNORM EN ISO 18113-1

Issue date: 2010 04 15

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.

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General information on ÖNORM EN ISO 18113-1

Format

Digital | 59 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 18113-1 from 2010 til today.

• ÖNORM EN ISO 18113-1

  2024 10 01 Standard ÖNORM EN ISO 18113-1, Edition: 2024 10 01

  In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1:...
• ÖNORM EN ISO 18113-1

  2012 12 01 Standard ÖNORM EN ISO 18113-1, Edition: 2012 12 01

  In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1:...
• ÖNORM EN ISO 18113-1

  2010 04 15 Standard ÖNORM EN ISO 18113-1, Edition: 2010 04 15

  In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 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	Link
Dokumentnummer ISO 1000:1992	Titel SI units and recommendations for the use of their multiples and of certain other units	Ausgabedatum 1992 11 12	Art Standard	Zur Produktseite
Dokumentnummer ISO 13485:2016	Titel Medical devices — Quality management systems — Requirements for regulatory purposes	Ausgabedatum 2016 02 25	Art Standard	Zur Produktseite
Dokumentnummer ISO 14971:2019	Titel Medical devices — Application of risk management to medical devices	Ausgabedatum 2019 12 10	Art Standard	Zur Produktseite
Dokumentnummer ISO 15223-1:2021	Titel Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Corrected version 2021-07)	Ausgabedatum 2021 07 06	Art Standard	Zur Produktseite

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