EN ISO 5364:2016

Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016) EN ISO 5364:2016

Publication date:   Jan 18, 2017

General information

99.60   Withdrawal effective   Jun 3, 2026

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 5364:2011

NOW

WITHDRAWN
EN ISO 5364:2016
99.60 Withdrawal effective
Jun 3, 2026

REVISED BY

PUBLISHED
EN ISO 5364:2026




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