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SSH EN ISO 5364:2016

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

Apr 28, 2017

General information

60.60     Jan 17, 2017

DPS

DPS/KT 215

European Norm

11.040.10  

English  

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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 directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

Replaces
SSH EN ISO 5364:2011

NOW

PUBLISHED
SSH EN ISO 5364:2016
60.60 Standard published
Jan 17, 2017

Related project

Adopted from EN ISO 5364:2016

Adopted from ISO 5364:2016

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