UNI EN ISO 5366-1 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
02-16-2017
01-01-2009
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Superseded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 | |
| Supersedes |
| 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 |
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