ISO 5364:2008 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

ISO 5364:2008 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*， 2009-12-01 Update
ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update

2016 ISO 5364:2016 Anaesthetic and respiratory equipment - Oropharyngeal airways
2008 ISO 5364:2008 Anaesthetic and respiratory equipment - Oropharyngeal airways
2001 ISO 5364:2001 Anaesthetic and respiratory equipment - Oropharyngeal airways
1992 ISO 5364:1986/Cor 1:1992 Oropharyngeal airways — Technical Corrigendum 1
1986 ISO 5364:1986 Oropharyngeal airways
1980 ISO 5364:1980 Oropharyngeal airways