DIN Standards Committee Technical Fundamentals
DIN EN ISO 14408
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016); German version EN ISO 14408:2016
Trachealtuben für die Laserchirurgie - Anforderungen an die Kennzeichnung und die begleitenden Informationen (ISO 14408:2016); Deutsche Fassung EN ISO 14408:2016
Overview
The standard applies to cuffed and uncuffed tracheal tubes designed for resistance to ignition by a laser. It specifies requirements for the marking of the tracheal tubes themselves, for the marking of the packaging for tracheal tubes and for the information to be provided by the manufacturer. The latter also include the specification of a standardized format for reporting the results of the laser resistance test. Compared to the August 2009 edition, revision has been carried out taking the ISO 11990 series of standards "Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes" into consideration. This standard has been prepared by ISO/TC 121/SC 2 "Airways and related equipment" (secretariat: ANSI, USA) in collaboration with CEN/TC 215 "Respiratory and anaesthetic equipment" (secretariat: 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
Document: referenced in 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
