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I.S. EN 1282-2:2005

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
Available format(s)

Hardcopy , PDF

Withdrawn date

13-05-2021

Language(s)

English

Published date

05-08-2005

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Describes requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm.

DevelopmentNote
2005 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (09/2009)
DocumentType
Standard
Pages
22
PublisherName
National Standards Authority of Ireland
Status
Withdrawn
Supersedes

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)

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