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UNI EN 1282-2 : 2009

Current
Current

The latest, up-to-date edition.

TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
Published date

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

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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