EN ISO 5364:2016

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Size designation and dimensions
5 Materials
6 Design
7 Performance requirements
8 Sterility assurance
9 Packaging of oropharyngeal airways supplied sterile
10 Marking
11 Information to be supplied by the manufacturer
Annex A (informative) - Rationale
Annex B (normative) - Test method for resistance to
        collapse of the buccal portion
Annex C (normative) - Test method for patency of lumen
Annex D (informative) - Guidance on materials and design
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC

ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.ISO 5364:2016 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.ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.