CEN - EN 13544-1
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
| Organization: | CEN |
| Publication Date: | 1 April 2007 |
| Status: | inactive |
| Page Count: | 46 |
| ICS Code (Anaesthetic, respiratory and reanimation equipment): | 11.040.10 |
scope:
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.,
or electrically-powered
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).
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