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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 (ISO 5366-1:2000)
08-04-2009
01-10-2016
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
Bibliography
Annex ZA (Informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Describes the requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of or greater.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes EN 1282-1 (08/2004)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 5366-1:2000 | Identical |
| BS EN ISO 5366-1:2004 | Identical |
| NEN EN ISO 5366-1 : 2009 | Identical |
| PN EN ISO 5366-1 : 2009 | Identical |
| NS EN ISO 5366-1 : 2009 | Identical |
| NF EN ISO 5366-1 : 2009 | Identical |
| I.S. EN ISO 5366-1:2009 | Identical |
| NBN EN ISO 5366-1 : 2009 | Identical |
| DIN EN ISO 5366-1:2009-07 | Identical |
| BS EN ISO 5366-1:2009 | Equivalent |
| UNE-EN ISO 5366-1:2009 | Identical |
| BS EN ISO 5366-1:2009 | Identical |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| EN 1282-2:2005+A1:2009 | Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
| I.S. EN 1282-2:2005 | TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| BS EN 1282-2 : 2005 | TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES |
| I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| DIN EN 1282-2:2009-12 | TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES |
| UNE-EN 1282-2:2006 | Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
| UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| 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 |
| 92/42/EEC : 1992 AMD 5 2013 | COUNCIL DIRECTIVE 92/42/EEC OF 21 MAY 1992 ON EFFICIENCY REQUIREMENTS FOR NEW HOT-WATER BOILERS FIRED WITH LIQUID OR GASEOUS FUELS |
| 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 |