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BS EN ISO 8836:2014 pdf free

BS EN ISO 8836:2014 pdf free.Suction catheters for use in the respiratory tract
It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. For example, the possibility of the misconnection of a small-bore connector to a specialized patient-access port can still exist. Specialized patient-access ports
often require the use of flexible materials which are intended to permit access by a range of medical devices or accessories, such as endoscopes, bronchoscopes and surgical instruments. These access ports an permit interconnection with some small-bore connectors. The risks associated with the use of
these specialized patient-access ports are not addressed by this International Standard. Manufacturers of medical devices or accessories and the committees responsible for the development of standards for medical devices or accessories that incorporate these specialized patient-access ports will need to assess these risks.
To reduce the hazards associated with residual vacuum all suction catheters used in the respiratory tract must be provided with a vacuum control device.
Internal volume is important because the design of the patient connection port should minimize dead space to reduce the volume of rebreathed gases. The design of the patient connection port should also minimize the accumulation of secretions.
Clinicians have noted the transmission of fluids from the vacuum control device during use. Fluids can contain pathogens. It is important, therefore, that these devices should not leak potentially contaminated fluids into the environment during their use. The vacuum control device may be a site of such a leak in the closed position, the open position, and during transition between the two states.
The positive pressure from the ventilator may potentially force contaminated fuids through the valve, particularly in the setting of a blockage in the suction line. A static leak test only assesses leakage in the closed position. The manufacturer should ensure that the vacuum control valve remains leak-free in all positions, even when the machine end is blocked and positive pressure applied to the patient end.BS EN ISO 8836 pdf download.

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