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) or manually-powered nebulizers.
NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185 "Humidifiers".
This European Standard does not include nebulizers precharged with a specific medicinal product and not for universal application.
Registration number (WIID)
9974
Scope
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) or manually-powered nebulizers.
NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185 "Humidifiers".
This European Standard does not include nebulizers precharged with a specific medicinal product and not for universal application.
