I.S. EN 1282-2:2005
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
13-05-2021
English
05-08-2005
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.
Dates of withdrawal of national standards are available from NSAI.
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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Withdrawn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 |
| Standards | Relationship |
| UNE-EN 1282-2:2006 | Identical |
| SN EN 1282-2 : 2005 + A1 2010 | Identical |
| BS EN 1282-2 : 2005 | Identical |
| NS EN 1282-2 : 2005 + A1 2009 | Identical |
| EN 1282-2:2005+A1:2009 | Identical |
| NF EN 1282-2 : 2005 + A1 2009 | Identical |
| NEN EN 1282-2 : 2005 + A1 2009 | Identical |
| UNI EN 1282-2 : 2009 | Identical |
| NBN EN 1282-2 : 2005 + A1 2009 | Identical |
| DIN EN 1282-2:2009-12 | Identical |
| 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 980:2008 | Symbols for use in the labelling of medical devices |
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