In the ISO 14408 standard developed by the International Standards Organization (ISO), the marking and performance characteristics and test methods of trachea tubes designed for laser surgery are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 14408 Trachea tubes designed for laser surgery - Features for marking and accompanying information.
This standard covers marking, labeling and information provided by the manufacturer for clamped and unclamped tracheal tubes and related materials designed to withstand laser ignition. The laser resistance of these tracheal tubes is tested according to ISO 11990-1 and ISO 11990-2 standards. The ISO 14408 standard offers a standard format for reporting the results obtained when tests in accordance with these two standards are performed. By the disclosure of the information suitable for this format and the limitation of the requirements, the design of the manufacturer and the maximum use of alternative materials are provided.
Tracheal tubes are medical types designed to be inserted through the larynx into the trachea to deliver gas and steam to the trachea. The trachea tube is inserted through a hole in the windpipe to help patients breathe. Trekea tubes help people with conditions that need to be on the ventilator for more than a few weeks or have conditions that block their upper respiratory tract. Briefly, a tracheal tube is a catheter that is inserted into the trachea to create and maintain an airway and to provide adequate oxygen and carbon dioxide exchange.
The standards that are referred to as normative in the implementation of this standard and indispensable for its implementation are: ISO 70001, ISO 15223-1, ISO 11990-1 and ISO 11990-2.
Our organization also provides businesses with marking and performance testing services for tracheal tubes designed for ISO 14408 laser surgery, as part of our laboratory services.
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