BS ISO 18835 pdf download – lnhalational anaesthesia systems—- Draw-overanaesthetic systems

BS ISO 18835 pdf download – lnhalational anaesthesia systems—- Draw-overanaesthetic systems.
3.1
carrier gas
respirable gas that carries the anaesthetic agent to the patient
Note 1 to entry: A common example ala car r icr gas Is entrained ambient air supplemented with oXygen.
3.2
draw-over anaesthetic system
low-resistance system for administering Enhalatiunal anaesthesia that can be used in the absence of compressed gas or electricity
3.3
draw-over valve system
a valve, or combination of valves, that controls unidirectional flow to the patient during inspiration
and unidirectional flow from the patient during exhalation under both spontaneous ventilation and
intermittent positive pressure ventilation (IPPV)
3.4
draw-over vaporizer
vaporizer from which a sufficient flow of gas vapour mixture is produced by lowering the pressure at the outlet of the vaporizer below that at its inlet by a patient’s inspiratory effort or by a ventilator
[SOURCE: ISO 4135:2001. 4.1.8, modified — the breathing system and the vaporizer are treated as separate devices in this International Standard, and thus, the phrase either in the breathing system and the vaponzer, as used in ISO 4135, is Inappropriate in this International Standardi
exhaust port
port through which the patient exhales to the atmosphere or into the inlet port of an anaesthetic gas scavenging transfer system
[SOURCE: ISO 4135:2001. 4.2.1.6. modified — in order to he more specific as the exhaust port is an integral part of the draw-over valve systemi
3.6
operator-detachable detachable without the use of a tool
3.7
patient connection port
opening at the patient end of a breathing system intended for connection of an airway device
[SOURCE: ISO 4135:2001,4.2.1.2, modified — the examples that were not considered necessary for this International Standard have been deleted)
3.8
reservoir
container where the carrier gas mixes with supplementary oxygen
4 General requirements
4.1 RIsk management
The manufacturer ala draw-over anaesthetic systemor parts Intended for use In a draw•ovcr anaesthetic system shall follow a risk management process in accordance with ISO 14971. Any unacceptable risk shall be mitigated by in this order:
a) design features which prevent the hazard;
b) inclusion of a means of protection;
5 Draw-over vaponzer
5.1 Construction
5.1.1 A visual indication of the level of liquid anaesthetic agent contained within the draw-over vaporizer shall be provided (see 211 f)J.
Check compliance by visual Inspection.
5.1.2 A control shall be provided to adjust the vapour concentration (volume fraction) calibrated for each intended anaesthetic agent and
a) undemomial operating conditions, it shall not be possible to set the control alxwe the calibrated range. b) the control can have a separate OFF position In addition to a ‘O orzero position, and
C) a means shall be provided to reduce the risk of unintended change of the control from its set position. Check compliance by visual inspection and functional testing.
5.1.3 When operated in accordance with the manufacturer’s instructions, it shall not be possible to overfil the draw-over vaporizer such that
a) its performance is affected, or
b) the fluid level is no longervisible onndicated.
Check compliance by visual inspection and functional testing.
5.1.4 The draw-over vaporizer shall either
a) be provided with mounting fittings suitable to enable it to be rigidly supported, or
b) have a base designed to provide stability wten freestanding.
Check compliance by visual inspection and functional testing.
5.2 Performance
5.2.1 The output in the 0, OFF’. or”zero position shall be less than 0,1 %. Check compliance by the test given in B.2.
5.2.2 • The accuracy of output shall be within ±20 % of set value forconcentrations (volume
fraction) greaterthan I % and ±50% of set value forconcentrations of I % orbelow underthe following conditions:
a) throughout the temperature range 0(20 C to 30 °C;
b) through the range of minute volumes from 2 Ito 8 I;
C) at a frequency of 12 breaths perminute:
d) using a sinusoidal wave form orat an l:E ratio of 1:1.
The manufacturer shall disclose, in his technical file, the test method used to confirm the accuracy reqirements of this International Standard.