RO
SR EN 13544-1:2007
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
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. 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).
Status :
Withdrawn
Approval date : 9/28/2007
Publish date : 9/30/2007
Withdrawal date : 1/29/2010
Number of pages : 42
ICS : 11.040.10 Anaesthetic, respiratory and reanimation equipment
Technical Committee : 377 - Medical devices
- Replaces SR EN 13544-1:2003/A1:2004
- Replaces SR EN 13544-1:2003
- Replaced by SR EN 13544-1+A1:2010