Name: UNI EN ISO 5366-1 : 2009
Brand: UNI

UNI EN ISO 5366-1 : 2009

Superseded

View Superseded by

ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS

Superseded date

16-02-2017

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
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 and labelling
Annexes
  A Test method for the security of attachment of connector
    and neck-plate to tracheostomy tube
    A.1 Principle
    A.2 Apparatus
    A.3 Procedure
    A.4 Expression of results
  B Test method for determining the resting diameter of the
    cuff
    B.1 Principle
    B.2 Apparatus
    B.3 Procedure
    B.4 Expression of results
  C 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
Bibliography

Describes requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of 6,5 mm or greater.

DevelopmentNote	Supersedes UNI EN 1282-1. (11/2004)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 5366 : 2017
Supersedes	UNI EN 1282-1 : 1998 UNI EN ISO 5366-1 : 2004

Standards	Relationship
ISO 5366-1:2000	Identical
BS EN ISO 5366-1:2004	Identical
UNE-EN ISO 5366-1:2009	Identical
NEN EN ISO 5366-1 : 2009	Identical
NS EN ISO 5366-1 : 2009	Identical
NF EN ISO 5366-1 : 2009	Identical
SN EN ISO 5366-1 : 2009	Identical
I.S. EN ISO 5366-1:2009	Identical
NBN EN ISO 5366-1 : 2009	Identical
EN ISO 5366-1:2009	Identical
DIN EN ISO 5366-1:2009-07	Identical

EN 556:1994 + A1:1998	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
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 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 5366-3:2001	Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes
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
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements