ISO 7197:2006 pdf download.Neurosurgical implants-Sterile,single-use hydrocephalus shunts and components.
3.2
hydrocephalus
state of excessive accumulation of cerebro-spinal thud CSF with the ventricular system of the head due to a disturbance of secretion, flow or absorption
3.3
hydrocephalus shunt
single-use device(s) typically consisting of an inflow catheter, a pressure-controlling device, and an outflow catheter intended to regulate the pressure of cerebro-spinal fluid CSF
3.4
Instructions for use
parts of accompanying documents provided by the manufacturer, giving the necessary Information for safe and proper use
3.3
lumbo-peritoneal drainage
drainage of cerebro-spwial fluid CSF from the lumbar sub-arachnoid spaces into the pentoneum
3.6
patient identification card
card identifying its holder and issuer, which carries data on the hydroceptialus shunt implanted
3-7
ventriculo-atrial drainage
drainage of cerebro-spinal fluid CSF from the ventricles into the right atrium of the heart
3.8
ventriculo-peritoneal drainage
drainage ol cerebra-spinal fluid CSF from the ventricles into the peritoneum
4 General requirements for shunts
4.1 General
The sample size shall be justified and stated.
4.2 Radiopacity
All extemal parts of the shunt or accessory device shall be radiopaque or shall carry radiopaque markers.
All parts of the shunt shal be identifiable via X-ray examination
NOTE Guidance can be Sound ii ASTM F640
4.3 Biocompatibility
The biocompatibility of hydrocephalus shunts and components shall be assessed. Guidance is given in the
principles and methods recommended in ISO 10993-1.
4.4 ResIstance to leakage
Resistance to leakage shall be measured using ar. All parts of the shunt shall show no signs of leakage with a differential pressure from inside to outside of 9,806 7 kPa (1 m water column) within 5 min.
hydrocephalus
state of excessive accumulation of cerebro-spinal thud CSF with the ventricular system of the head due to a disturbance of secretion, flow or absorption
3.3
hydrocephalus shunt
single-use device(s) typically consisting of an inflow catheter, a pressure-controlling device, and an outflow catheter intended to regulate the pressure of cerebro-spinal fluid CSF
3.4
Instructions for use
parts of accompanying documents provided by the manufacturer, giving the necessary Information for safe and proper use
3.3
lumbo-peritoneal drainage
drainage of cerebro-spwial fluid CSF from the lumbar sub-arachnoid spaces into the pentoneum
3.6
patient identification card
card identifying its holder and issuer, which carries data on the hydroceptialus shunt implanted
3-7
ventriculo-atrial drainage
drainage of cerebro-spinal fluid CSF from the ventricles into the right atrium of the heart
3.8
ventriculo-peritoneal drainage
drainage ol cerebra-spinal fluid CSF from the ventricles into the peritoneum
4 General requirements for shunts
4.1 General
The sample size shall be justified and stated.
4.2 Radiopacity
All extemal parts of the shunt or accessory device shall be radiopaque or shall carry radiopaque markers.
All parts of the shunt shal be identifiable via X-ray examination
NOTE Guidance can be Sound ii ASTM F640
4.3 Biocompatibility
The biocompatibility of hydrocephalus shunts and components shall be assessed. Guidance is given in the
principles and methods recommended in ISO 10993-1.
4.4 ResIstance to leakage
Resistance to leakage shall be measured using ar. All parts of the shunt shall show no signs of leakage with a differential pressure from inside to outside of 9,806 7 kPa (1 m water column) within 5 min.
