Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

EN 1282-2:2005+A1:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date

26-10-2016

Published date

12-08-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Size designation and dimensions
5 Materials
6 Design and finish
7 Requirements for tracheostomy tubes supplied sterile
8 Marking
9 Adaptor
Annex A (normative) - Test for security of attachment of
                      permanently attached connector, if
                      provided, and neck-plate to tracheostomy
                      tube
Annex B (normative) - Test method for determining the
                      resting diameter of the cuff
Annex C (informative) - Guidance on materials and design
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC
Bibliography

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.

Committee
CEN/TC 215
DevelopmentNote
2005 Edition Re-Issued in August 2009 & incorporates AMD 1 2009. (09/2009)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
DIN EN 1733:2003-02 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 1733:2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
EN 1733 : 2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
BS EN 1733:2002 Suction catheters for use in the respiratory tract

EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
EN 980:2008 Symbols for use in the labelling of medical devices
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more