Need help?

EN 1282-2:2005/A1:2009 Standard

wave
Save  

  Keywords:

#tracheostomy #mm #tubes #paediatric #specialized

  Directive

Medical devices Directive (93/42/EEC)

  Description:

Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

  Purpose

This European Standard specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube connectors and adaptors are also given. This document is not applicable to specialized tracheostomy tubes.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 1282-2:2005"

  Reference

This standard supersedes the "EN 1282-2:2005"

Anyway is still possible use the "EN 1282-2:2005" until March 21st, 2010

  Related Standards

EN ISO 22442-1:2020

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

EN 13726-1:2002/AC:2003

Medical devices Directive (93/42/EEC)

Test methods for primary wound dressings - Part 1: Aspects of absorbency

EN ISO 10993-5:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 11990-1:2014

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-...

EN ISO 11990-2:2014

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-...

EN 13060:2014

Medical devices Directive (93/42/EEC)

Small steam sterilizers

  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 1282-2:2005/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