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 devices) or
manually-powered nebulizers.
This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI,
DPI).