This International Standard specifies requirements for plastic and/or rubber oropharyngeal tubes, with or without plastic and/or metal reinforcing insert. This International Standard does not apply to metal oropharyngeal tubes and does not contain requirements for the flammability of oropharyngeal tubes. The flammability of oropharyngeal tubes, e.g. B. the use of flammable anesthetics, electrosurgical devices or lasers, is a known hazard. It is taken into account through appropriate clinical management, which is not the scope of this International Standard. This International Standard does not apply to supralaryngeal tubes without an internal, integrated sealing mechanism.
EN ISO 5364:2016 Referenced Document
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11712:2009 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
EN ISO 5364:2016 history
2016EN ISO 5364:2016 Anaesthetic and respiratory equipment - Oropharyngeal airways
2011EN ISO 5364:2011 Anaesthetic and respiratory equipment - Oropharyngeal airways