The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1.1This 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).
EN 13544-1:2007 history
2009EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
2007EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components (Incorporates Amendment A1: 2009)
2004EN 13544-1:2004 Respiratory therapy equipment Part 1: Nebulizing systems and their components (Incorporates Amendment A1: 2004)
2001EN 13544-1:2001 Respiratory Therapy Equipment - Part 1: Nebulizing Systems and Their Components