DIN EN ISO 5361:2013-03

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 remarks on the important requirements in comparison with the previous edition. The latter concern in particular the expansion of the scope, modification in the dimensions, incorporation of cuff performance requirements including incorporation of test methods for determination of tracheal seal and kink resistance. The standard supersedes DIN EN 1782:2009-12 which has been expanded in the scope by incorporation of speciality tubes and Cole-type tracheal tubes. The standard concretizes the relevant Essential Requirements of Directive 93/42/EEC on medical devices. The standard has been prepared by ISO/TC 121 "Anaesthetic and respiratory equipment" (secretariat: ANSI, USA) in cooperation with Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment", the secretariat of which is held by BSI, United Kingdom with the participation of German experts. At DIN, the German Institute for Standardization, e. V., the Rescue Services and Hospital Standards Committee (NARK), Working Committee NA 053-03-02 AA "Medizinprodukte für das Atemwegssystem" ("Airways and related equipment") is responsible.