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STANDARD

Current

ÖNORM EN ISO 27427

Issue date: 2024 01 01

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)

This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system. This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers. This document does not specify the electrical requirements of electrically powered nebulizers. This document does not specify the minimum performance of nebulizing systems. This document does not apply to: a) devices intended for nasal deposition; b) devices intended solely to provide humidification or hydration by providing water in aerosol form. c) drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).

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General information on ÖNORM EN ISO 27427

Format

Digital | 46 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 27427 from 2002 til today.

• ÖNORM EN ISO 27427

  2024 01 01 Standard ÖNORM EN ISO 27427, Edition: 2024 01 01

  Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
• ÖNORM EN ISO 27427

  2020 02 15 Standard ÖNORM EN ISO 27427, Edition: 2020 02 15

  Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)
• ÖNORM EN 13544-1

  2010 02 01 Standard ÖNORM EN 13544-1, Edition: 2010 02 01

  Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• ÖNORM EN 13544-1

  2007 08 01 Standard ÖNORM EN 13544-1, Edition: 2007 08 01

  Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• ÖNORM EN 13544-1

  2007 07 01 Standard ÖNORM EN 13544-1, Edition: 2007 07 01

  Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• ÖNORM EN 13544-1

  2004 11 01 Standard ÖNORM EN 13544-1, Edition: 2004 11 01

  Respiratory therapy equipment - Part 1: Nebulizing systems and their components (consolidated versio...
• ÖNORM EN 13544-1

  2002 01 01 Standard ÖNORM EN 13544-1, Edition: 2002 01 01

  Respiratory therapy equipment - Part 1: Nebulizing systems and their components

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Frequently Asked Questions about ÖNORM EN ISO 27427

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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 18190:2016	Titel Anaesthetic and respiratory equipment — General requirements for airways and related equipment	Ausgabedatum 2016 10 21	Art Standard	Zur Produktseite
Dokumentnummer ISO 18562-1:2017	Titel Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process	Ausgabedatum 2017 03 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 5356-1:2015	Titel Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets	Ausgabedatum 2015 03 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 7396-1:2016	Titel Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum	Ausgabedatum 2016 02 15	Art Standard	Zur Produktseite

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