UNI EN 1282-2 : 2009
Current
The latest, up-to-date edition.
TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
28-10-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Size designation and dimensions
4.1 Designation of size of tube
4.2 Outside diameter
4.3 Length
4.4 Angle
5 Materials
6 Design and finish
6.1 Machine end
6.2 Paediatric tracheostomy tube connector
6.3 Inner tube
6.4 Neck-plate
6.5 Cuff
6.6 Inflating tubes for cuffs
6.7 Patient end
6.8 Introducer
7 Requirements for tracheostomy tubes supplied sterile
7.1 Sterility assurance
7.2 Packaging for tracheostomy tubes supplied sterile
8 Marking
8.1 Marking of tracheostomy tube
8.2 Marking of tracheostomy tube connectors
8.3 Marking of unit packs
9 Adaptor
Annex A (normative) - Test for security of attachment of
permanently attached connector, if provided, and
neck-plate to tracheostomy tube
A.1 Principle
A.2 Apparatus
A.3 Procedure
A.4 Expression of results
Annex B (normative) - Test method for determining the
resting diameter of the cuff
B.1 Principle
B.2 Apparatus
B.3 Procedure
B.4 Expression of results
Annex C (informative) - Guidance on materials and design
C.1 Materials
C.2 Design
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC Medical devices
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.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| I.S. EN 1282-2:2005 | Identical |
| 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 |
| 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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