SS-EN-13544-1 › Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
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).
To find similar documents by classification:
11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
Medical devices. Revised Machinery Directive
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Designation Name
SS-EN 13544-1:2007+A1:2009
Revision Level
2007/A1 EDITION
Status
Current
Publication Date
Aug. 31, 2009
Language(s)
English
Page Count
52
International Equivalent
EN 13544-1:2007+A1:2009(IDT)