UNE-EN ISO 5364:2017
Current
The latest, up-to-date edition.
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
Hardcopy , PDF
Spanish, Castilian, English
12-04-2017
This International Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.This International Standard is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.Flammability of oropharyngeal airways, for example if flammable anaesthetics, electrosurgical units or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard.This International Standard is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.
| Committee |
CTN 110
|
| DevelopmentNote |
Supersedes UNE EN 12181. (11/2011)
|
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| ISO 5364:2016 | Identical |
| EN ISO 5364:2016 | Identical |
| ISO 11712:2009 | Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors |
| 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/TR 11991:1995 | Guidance on airway management during laser surgery of upper airway |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 4135:2001 | Anaesthetic and respiratory equipment — Vocabulary |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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