I.S. EN 1282-2:2005
Withdrawn
TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
Hardcopy , PDF
English
08-05-2005
05-13-2021
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Withdrawn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 |
| Standards | Relationship |
| 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 |
| NBN EN 1282-2 : 2005 + A1 2009 | Identical |
| DIN EN 1282-2:2009-12 | Identical |
| EN 1282-2:2005 | Equivalent |
| DIN EN 1282-2:2005-09 | Equivalent |
| UNE-EN 1282-2:2006 | 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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