NF ISO 27427

NF ISO 27427

January 2014
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.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2014

Number of pages

58 p.

Reference

NF ISO 27427

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S90-274

Print number

1

International kinship

ISO 27427:2013
Sumary
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.

Standard replaced by (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
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    3
  • 4 Exigences générales et exigences relatives aux essais
    5
  • 4.1 Gestion des risques
    5
  • 4.2 Méthodes d'essai et alternatives
    5
  • 4.3 Sécurité électrique
    6
  • 4.4 Sécurité mécanique
    6
  • 4.5 Sécurité pneumatique
    6
  • 4.6 Protection contre les déréglages involontaires
    6
  • 4.7 Aptitude à l'utilisation
    6
  • 5 Marquage
    6
  • 5.1 Symboles
    6
  • 5.2 Marquage sur le dispositif
    7
  • 5.3 Étiquetage sur l'emballage ou l'emballage individuel
    7
  • 5.4 Mode d'emploi, notices et documents d'accompagnement
    8
  • 6 Exigences de construction
    12
  • 6.1 Matériaux
    12
  • 6.2 Raccords
    12
  • 6.3 Commandes par rotation
    14
  • 7 Nettoyage, stérilisation et désinfection
    15
  • 8 Biocompatibilité
    15
  • Annexe A (informative) Exposé des motifs
    16
  • Annexe B (normative) Diamètres des particules à fraction respirable
    20
  • Annexe C (normative) Méthodes d'essai pour l'aérosol produit et le débit d'aérosol produit
    21
  • Annexe D (normative) Méthodes d'essai pour la granulométrie
    24
  • Annexe E (informative) Identification des phénomènes dangereux pour l'évaluation des risques
    33
  • Annexe F (informative) Classification des nébuliseurs à usage général
    39
  • Annexe G (informative) Aspects environnementaux
    41
  • Annexe AA (informative) Conformité aux principes essentiels
    43
  • Bibliographie
    48
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