Need help?

EN ISO 8185:2009 Standard

wave
Save  

  Keywords:

#breathing #tubes #heated #performance #international

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)

  Purpose

This International Standard includes requirements for the basic safety and essential performance of humidification systems, as defined in 3.6. This International Standard also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 8185:2007"

Anyway is still possible use the "EN ISO 8185:2007" until March 21st, 2010

  Related Standards

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 ISO 25539-1:2009/AC:2011

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

EN 60601-1-6:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Us...

EN 60601-1-4:1996

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical sy...

EN 60601-1-3:2008/A11:2016

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Ra...

EN 60601-1-3:2008/AC:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Ra...

  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 ISO 8185:2009 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