Need help?

EN ISO 5366-1:2009 Standard

wave
Save  

  Keywords:

#part #restricted #need #uses #applicable

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

  Purpose

This part of ISO 5366 specifies requirements for tracheostomy tubes made of plastics materials and/or rubber havinginside diameters of 6,5mm or greater. Such tubes are primarily designed for patients who require anaesthesia, arti-ficial ventilation or other respiratory support, but need not be restricted to these uses.This part of ISO 5366 is not applicable to specialized tubes, and does not address flammability of tracheostomytubes.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 5366-1:2004"

Anyway is still possible use the "EN ISO 5366-1:2004" until March 21st, 2010

  Related Standards

EN 60601-2-11:1997/A1:2004

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipmentIEC 60601-2-11:199...

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 14931:2006

Medical devices Directive (93/42/EEC)

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety re...

EN ISO 14971:2012

Medical devices Directive (93/42/EEC)

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

EN ISO 15001:2011

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

EN ISO 15004-1:2009

Medical devices Directive (93/42/EEC)

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic ins...

  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 5366-1:2009 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