99.60 Withdrawal effective Apr 25, 2007
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
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.
Legislation related to this standard
WITHDRAWN
EN 13544-1:2001
99.60
Withdrawal effective
Apr 25, 2007
WITHDRAWN
EN 13544-1:2007