BS EN ISO 8836-2014 pdf download.Suction catheters for use in the respiratory tract (ISO 8836:2014).
6.6 The mid-section of the shaft of suction catheters shall allow visualization of secretions removed from the respiratory tract.
Check compliance by visual inspection
6.7 If phthalates as categorized in EN 15986 are incorporated in parts of the medical devices coming directly or indirectly into contact with the patient, the manufacturer shall identify the individual risks for the affected patient populations [see 10.3.2 I)].
Check compliance by inspection of the risk management file.
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7.1 Lumen of the suction catheter
The inside diameter of the shaft at any point between the suction catheter connector machine end and the eye nearest to the machine end shall be not less than the inside diameter of the shaft at that eye.
7.2 Suction catheter tip
7.2.1 Suction catheters on which the patient end cannot be observed during use or which are for use with suction systems operating at a vacuum pressure> 3,92 kPa, (40 cm II 20), shall have a terminal orifice and at least one eye within 2 cm of the terminal orifice.
NOTE The availability of one or more eyes reduces the risk and likelihood of injury.
7.2.2 Suction catheters that can be observed during use, or are for use with suction systems operated
at vacuum from 0 cm H20 to 40 cmH2O (3,92 kPa), need not have an eye.
7.2.3 The edges of the tip, terminal orifice and eye(s) shall be smooth.
NOTE This is to minimize injuries of the tracheal epithelium.
Check compliance by visual inspection.
7.2.4 The eye(s) should not cause the suction catheter to kink or collapse during use.
7.2.5 The axis of the patient end may be at an angle to the long axis of the shaft (see Coudé catheter tip in Figu.reJ).
NOTE This is to facilitate the introduction of the suction catheter into the left or main bronchus.
7.3 *Suction catheter connector
7.3.1 A suction catheter shall be provided with a male suction catheter connector intended for connection to the end-piece of suction tubing attached to a collection container that complies with
ISO 10079-1, ISO 10079-2, and ISO 10079-3.
A male suction catheter connector is required in order to comply with the ISO 10079-1. 150 10079-2, and ISO 10079-3 requirement that connections for the suction tubing be so designed as to minimize the risk of wrong assembly when all parts are mated. The use of a male suction catheter connector also distinguishes the use of the suction catheter from urethral catheters, umbilical catheters, thoracic catheters, feeding tubes, and other catheters not designed for use in the respiratory tract.BS EN ISO 8836 pdf download.