Overview

The standard contains requirements for tracheal tubes and associated respiratory equipment. The scope includes tracheal tubes with cuffs, Cole-type tracheal tubes as well as speciality tracheal tubes, for example, tracheal tubes with reinforced walls, tracheal tubes with shoulders, tracheal tubes with means for suctioning or delivery of drugs. The general requirements for the risk assessment and safety as well as the essential requirements for the design including materials, marking and packaging are specified. The general requirements are supplemented by the necessary test methods. Furthermore, guidance for hazard identification and risk assessment and for the design of tracheal tube connectors is provided in informative annexes. Another informative annex contains explanations of the essential requirements. Compared to the previous edition from January 2017, additional requirements for tracheal tubes for children and neonates have been added and requirements for special Magill-type tracheal tubes and preformed tracheal tubes have been clarified. This document has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and respiratory equipment" (secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment" (secretariat: BSI, United Kingdom), with the participation of German experts. The responsible German committee is Working Committee NA 053-03-02 AA "Medizinprodukte für das Atemwegssystem" ("Airways and related equipment") at DIN Standards Committee Rescue Services and Hospital (NARK).

Document: references other documents

Responsible national committee

NA 176-05-05 AA - Airways and related equipment  

Responsible european committee

CEN/TC 215/WG 4 - Airway devices, related equipment and suction devices  

Responsible international committee

ISO/TC 121/SC 2 - Airway devices and related equipment