60.60 Standard published Sep 28, 2016
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
Published
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.
Legislation related to this standard
WITHDRAWN
EN ISO 5364:2011
PUBLISHED
EN ISO 5364:2016
60.60
Standard published
Sep 28, 2016
