Need help?

EN 13544-1:2007/A1:2009 Standard

wave
Save  

  Keywords:

#powered #nebulizers #european #standard #used

  Directive

Medical devices Directive (93/42/EEC)

  Description:

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

  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

Friday 17th of November 2017

  Amendment

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

  Reference

This standard supersedes the "EN 13544-1:2007"

Anyway is still possible use the "EN 13544-1:2007" until March 21st, 2010

  Related Standards

EN ISO 5359:2008/A1:2011

Medical devices Directive (93/42/EEC)

Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)

EN ISO 5361:2016

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)

EN 1639:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Instruments

EN 1640:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Equipment

EN 1641:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Materials

EN 1789:2020

Medical devices Directive (93/42/EEC)

Medical vehicles and their equipment - Road ambulances

  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