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SSH EN ISO 5361:2016

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)

Apr 28, 2017
95.99 Withdrawal of Standard   Jul 23, 2024

General information

95.99     Jul 23, 2024

DPS

DPS/KT 215

European Norm

11.040.10  

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Scope

ISO 5361:2016 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.
Endobronchial (including tracheobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are excluded from the scope of ISO 5361:2016.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of ISO 5361:2016.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 5361:2012

WITHDRAWN
SSH EN ISO 5361:2012/AC:2012

NOW

WITHDRAWN
SSH EN ISO 5361:2016
95.99 Withdrawal of Standard
Jul 23, 2024

REVISED BY

PUBLISHED
SSH EN ISO 5361:2023

Related project

Adopted from EN ISO 5361:2016

Adopted from ISO 5361:2016