EN ISO 5361:2016

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

Publication date:   Jan 18, 2017

General information

99.60 Withdrawal effective   Feb 1, 2023

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

Buying

  Withdrawn

PDF - €68.52

  English  



Buy

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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 5361:2012

WITHDRAWN
EN ISO 5361:2012/AC:2012

NOW

WITHDRAWN
EN ISO 5361:2016
99.60 Withdrawal effective
Feb 1, 2023

REVISED BY

PUBLISHED
EN ISO 5361:2023