CEN - EN 13544-1
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
|Publication Date:||1 April 2007|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following:
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.,
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).