BS EN ISO 5364:2011 PDF

Scope: 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.

BS EN ISO 5364:2011 Referenced Document

EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-19 Update
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update

2016 BS EN ISO 5364:2016 Anaesthetic and respiratory equipment. Oropharyngeal airways
2011 BS EN ISO 5364:2011 Anaesthetic and respiratory equipment. Oropharyngeal airways
1998 BS EN 12181:1998 Oropharyngeal Airways

BS EN ISO 5364:2011 Anaesthetic and respiratory equipment. Oropharyngeal airways has been changed from BS EN 12181:1998 Oropharyngeal Airways.