Norme NBN EN 13544-1+A1:2009
Matériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs composants
Statut
:
Remplacée
Date de publication
:
10/2009
Langues
:
EN/FR/DE
ICS
:
11.040.10 Matériel d'anesthésie, de réanimation et respiratoire
Sommaire :
The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following:
1.1 This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system.
This European Standard includes gas-powered nebulizers which may be derived from e.g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic and membrane device
s) or manually-powered nebulizers. NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185:1997 + AC: 2002 "Humidifiers" (see 56.102). This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI, DPI).
s) or manually-powered nebulizers. NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185:1997 + AC: 2002 "Humidifiers" (see 56.102). This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI, DPI).
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