EN 13544-1:2007

The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following:1.1This 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 devices) or manually-powered nebulizers.NOTERequirements 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).