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EN 13544-1:2001

Respiratory therapy equipment - Part 1: Nebulizing systems and their components EN 13544-1:2001

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Apr 25, 2007

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

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) or manually-powered nebulizers.

NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185 "Humidifiers".
This European Standard does not include nebulizers precharged with a specific medicinal product and not for universal application.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

NOW

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EN 13544-1:2001
99.60 Withdrawal effective
Apr 25, 2007

CORRIGENDA / AMENDMENTS

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EN 13544-1:2001/A1:2004

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EN 13544-1:2001/AC:2004

REVISED BY

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EN 13544-1:2007