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SRPS EN ISO 5364:2017

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

Sep 25, 2017

General information

60.60     Sep 25, 2017

ISS

Z076

European Norm

11.040.10  

English  

Plan 2017.

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Published

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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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 5364:2012

NOW

PUBLISHED
SRPS EN ISO 5364:2017
60.60 Standard published
Sep 25, 2017

REVISED BY

PROJECT
naSRPS EN ISO 5364:2024

Related project

Adopted from EN ISO 5364:2016

Adopted from ISO 5364:2016