Need help?

EN ISO 9360-1:2009 Standard

wave
Save  

  Keywords:

#hmes #test #anddescribes #port #machine

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)

  Purpose

This part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including thoseincorporating breathing system filters, intended for the humidification of respired gases for use primarily withpatients with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port, anddescribes test methods for their evaluation.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 9360-1:2000"

Anyway is still possible use the "EN ISO 9360-1:2000" until March 21st, 2010

  Related Standards

EN 12470-1:2000+A1:2009

Medical devices Directive (93/42/EEC)

Clinical thermometers - Part 1: Metallic liquid- in-glass thermometers with maximum device

EN ISO 15883-2:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instrumen...

EN ISO 11607-1:2020

Medical devices Directive (93/42/EEC)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 11737-2:2020

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

EN ISO 14155:2020

Medical devices Directive (93/42/EEC)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

EN ISO 22442-2:2020

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-...

  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 9360-1:2009 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