BS EN 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 this International Standard.

Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this International Standard.

NOTE References [1] to [4] deal with laser surgery of the airway.


Cross References:
ISO 594-1
ISO 5356-1
ISO 7000
ISO 10993-1
ISO 11135
ISO 11137-1
ISO 11607-1
ISO 14155
ISO 14971:2007
ISO 15223-1
ISO 15223-2
EN 556-1:2001
EN 1041
ASTM F640-12
ASTM D3002-07
ISO/TR 11991:1995
ISO 11990-1:2011
ISO 11990-2:2010
ISO 14408:2005
ISO 4135
IEC 62366
ANSI Z-79.16 1983
ASTM F1242-96
93/42/EEC


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