ISO 8600-1:2013 pdf free

ISO 8600-1:2013 pdf free.Endoscopes一Medical endoscopes and endotherapy devices
Depending on their utilization, endoscopes and endotherapy devices shall be provided with fittings for input or output of liquid or gaseous media. The manufacturer of endoscopes and endotherapy devices shall carry out a risk management procedure in accordance with ISO 14971 to consider the probability of misconnection of medical devices intended for connection to endoscopes or endotherapy devices to non-endoscopic patient connections (e.g. intravenous applications).
The purpose of a risk management procedure is to assess both the physical possibility of a misconnection of such medical devices to non-endoscopic patient connections, particularly to Luer connectors in accordance with ISO 594-1 and ISO 594-2, and the probability of occurrence of such a misconnection,together with the potential severity of harm for the patient. Where relevant standards exist for connectors that match the intended use of the endoscope, endotherapy device or medical device intended for connection to endoscopes or endotherapy devices, these should be used unless contra-indicated by the risk management procedure.
Guidelines on the application of risk management to endoscopic system connectors are given in Annex A for information.
If the endoscope has a hand wheel (knob type) deflection control system for the controllable portion and if the hand wheel(s) are located on the right hand side of the proximal part/control body (from the user’s point of view), then the deflection control system shall fulfil the conditions given in 4.10.2 to 4.10.5.
If the endoscope has a deflection control system other than what is described below, the endoscope shall have labelling indicating the direction in which the controller moves and the corresponding direction of the deflection of the controllable portion.
NOTE Hand wheel deflection control system means a deflection control system with a knob type wheel rotated by the user’s hand.
When the insertion portion is in a straight position and the hand wheel for up- down deflection is moved anticlockwise, the controllable portion shall be deflected up, and vice versa. See Figure 4 a).
When the insertion portion is in a straight position and the hand wheel for right-left deflection is moved anticlockwise, the controllable portion shall be deflected to the left, and vice versa. See Figure 4 b).ISO 8600-1 pdf download.