In the ISO 5361 standard developed by the International Standards Organization (ISO), the basic safety and performance characteristics and test methods of trachea tubes and fittings, which are anesthesia and respiratory equipment, are explained. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 5361 Anesthesia and respiratory equipment - Trachea tubes and fittings.
This standard provides basic performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube fittings. This international standard mainly covers the following equipment:
However, endobronchial tubes, tracheostomy tubes, and supralaryngeal airways are not covered by this standard. Tracheal tubes intended for use with flammable anesthetic gases or substances, lasers, or electrosurgical equipment are also excluded from this standard.
Tracheal tubes should be as close as possible to human anatomy during use. With clinical concerns, the length of the tracheal tubes has also been determined. Sometimes relatively narrow diameter long tracheal tubes are used. The standard includes provision for pre-cut tracheal tubes. Test methods applied include bending resistance, the ability of the shaft of the tracheal tube to resist collapse, and breathing resistance tests that increase when bent.
Several standards with normative reference in the application of this standard are: ISO 594-11, ISO 5356-1, ISO 70002, ISO 10993-1, ISO 11135, ISO 11137-1 and ISO 11607-1.
Within the scope of laboratory services, our organization also provides basic safety and performance testing services for trachea tubes and fittings, which are ISO 5361 anesthesia and breathing equipment.
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