International Standard
ISO 27427:2023
Anaesthetic and respiratory equipment — Nebulizing systems and components
Reference number
ISO 27427:2023
Edition 4
2023-07
International Standard
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ISO 27427:2023
78542
Published (Edition 4, 2023)

ISO 27427:2023

ISO 27427:2023
78542
Language
Format
CHF 151
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Abstract

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.

NOTE 1        ISO 80601-2-74 and ISO 20789 cover these devices.

c)        drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).

NOTE 2        ISO 20072 covers these devices.

NOTE 3        See Annex A for rationale.

General information

  •  : Published
     : 2023-07
    : International Standard published [60.60]
  •  : 4
     : 33
  • ISO/TC 121/SC 2
    11.040.10 
  • RSS updates

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