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 1642:2011

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Dental implants

EN 20594-1:1993/A1:1997

Medical devices Directive (93/42/EEC)

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (...

EN ISO 23328-2:2009

Medical devices Directive (93/42/EEC)

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

EN ISO 23328-1:2008

Medical devices Directive (93/42/EEC)

Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 2332...

EN ISO 22675:2016

Medical devices Directive (93/42/EEC)

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)

EN ISO 22523:2006

Medical devices Directive (93/42/EEC)

External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

  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