DIN EN 1282-2:2009 PDF

Scope: This documents specifies requirements for paediatric tracheostomie tubes made of plastic 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.

DIN EN 1282-2:2009 Referenced Document

EN 20594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986); Amendment A1
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-19 Update
EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)*， 2020-11-30 Update
EN ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)*， 2015-03-01 Update
EN ISO 5366-1:2004 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults
ISO 11607 Packaging for terminally sterilized medical devices
ISO 5361 Anaesthetic and respiratory equipment — Tracheal tubes and connectors*， 2023-01-17 Update

2017 DIN EN ISO 5366:2017 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016); German version EN ISO 5366:2016
2009 DIN EN 1282-2:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified); German version EN 1282-2:2005+A1:2009
2005 DIN EN 1282-2:2005 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified); German version EN 1282-2:2005