Need help?

EN 13544-1:2007+A1:2009 Standard

wave
Save  

  Keywords:

#powered #nebulizers #european #standard #used

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Respiratory therapy equipment - Part 1: Nebulizing systems and their component

  Purpose

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.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 13544-1:2007"

  Related Standards

EN 60601-2-25:1995/A1:1999

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographsIEC 60601-2-25:1993

EN 60645-2:1997

Medical devices Directive (93/42/EEC)

Audiometers - Part 2: Equipment for speech audiometryIEC 60645-2:1993

EN 455-3:2006

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

EN 455-1:2000

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN 80601-2-59:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening ther...

EN 80601-2-58:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal d...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 13544-1:2007+A1:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0