BAS EN 13544-1:2008
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
General Information
Status: Withdrawn
No. of pages: 44
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 21.07.2008
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
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).
Lifecycle
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Original document and degree of correspondence
- EN 13544-1:2007, identical