ISO 5366:2016
Current
The latest, up-to-date edition.
Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
30-09-2016
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ISO 5366:2016 specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support.
ISO 5366:2016 is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases.
Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addressed by appropriate clinical management and is outside the scope of this International Standard.
NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.
| DevelopmentNote |
Supersedes ASTM F 1590 and ASTM F 1666. (02/2004) Supersedes ISO/DIS 5366, ISO 5366-1 & ISO 5366-3. (10/2016)
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| DocumentType |
Standard
|
| Pages |
27
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| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| DIN EN ISO 5366:2017-04 | Identical |
| NF EN ISO 5366 : 2016 | Identical |
| NS EN ISO 5366 : 2016 | Identical |
| PN EN ISO 5366 : 2017 | Identical |
| SN EN ISO 5366 : 2017 | Identical |
| UNI EN ISO 5366 : 2017 | Identical |
| SS-EN ISO 5366:2016 | Identical |
| I.S. EN ISO 5366:2016 | Identical |
| UNE-EN ISO 5366:2017 | Identical |
| BS EN ISO 5366:2016 | Identical |
| EN ISO 5366:2016 | Identical |
| DIN EN ISO 5366:2015-10 (Draft) | Identical |
| IS 18377 : 2024 | Identical |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| 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 |
| ASTM F 640 : 2012 : REDLINE | Standard Test Methods for Determining Radiopacity for Medical Use |
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