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EN 13544-1:2007

Respiratory therapy equipment - Part 1: Nebulizing systems and their components EN 13544-1:2007

Publication date:   Dec 20, 2008

General information

99.60 Withdrawal effective   Aug 19, 2009

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 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).

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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Life cycle

PREVIOUSLY

WITHDRAWN
EN 13544-1:2001/A1:2004

WITHDRAWN
EN 13544-1:2001/AC:2004

WITHDRAWN
EN 13544-1:2001

NOW

WITHDRAWN
EN 13544-1:2007
99.60 Withdrawal effective
Aug 19, 2009

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
EN 13544-1:2007/prA1