Overview

The standard contains requirements for the design of trachetomy tubes with and without a cuff. These products are used for insertion into the trachea through a stoma in order to conduct gases and vapors into and out of the trachea. The standard is also applicable to specialized tracheostomy tubes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases. The standard covers requirements including relevant test methods for tracheostomy tubes for adults as well as for pediatric applications and replaces the standards DIN EN 1282-2:2009-12 and DIN EN ISO 5366-1:2009-07, which cover these two applications separately. The standard has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and respiratory equpiment" (secretariat ANSI, USA) in collaboration with Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment", the secretariat of which is held by BSI, United Kingdom. The responsible national 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 - Respiratory and anaesthetic equipment  

Responsible international committee

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