AAMI 5361

Description / Abstract: This International Standard 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, taperd tracheal tubes, tracheal tubes with means for suctioning or 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.

Tracheobronchial (endobronchial) 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 ISO/TR 11991, ISO 11990-1, ISO 11990-2, and ISO 14408 cover this