NF EN ISO 27427

NF EN ISO 27427

August 2023
Standard Current

Anaesthetic and respiratory equipment - Nebulizing systems and components

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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2023

Number of pages

45 p.

Reference

NF EN ISO 27427

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S90-274

Print number

1

International kinship

ISO 27427:2023

European kinship

EN ISO 27427:2023
Sumary
Anaesthetic and respiratory equipment - Nebulizing systems and components

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.

Replaced standards (1)
NF EN ISO 27427
September 2019
Standard Cancelled
Anaesthetic and respiratory equipment - Nebulizing systems and components

ISO 27427:2013 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. ISO 27427:2013 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.

Table of contents
  • 1 Domaine d'application
  • Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales et exigences relatives aux essais
  • 5 Matériaux
  • 6 Exigences de conception
  • 7 Exigence relative aux systèmes de nébulisation et aux composants fournis à l'état stérile
  • 8 Emballage
  • 9 Informations fournies par le fabricant
  • Annexe A (informative) Justifications
  • Annexe B (informative) Diamètres de la fraction respirable des particules
  • Annexe C (normative) Méthodes d'essai pour l' aérosol produit et le débit d'aérosol produit
  • Annexe D (normative) Méthodes d'essai pour mesurer la taille des particules
  • Annexe E (informative) Identification des phénomènes dangereux pour l'évaluation des risques
  • Annexe F (informative) Classification des nébuliseurs à usage général
  • Bibliographie
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