YY/T 0487-2010 Translated English of Chinese Standard. (YYT 0487-2010, YY/T0487-2010, YYT0487-2010): Sterile, single-use hydrocephalus shunts and components
https://www.chinesestandard.net, 2015 M12 13 - 14 pages
This Standard specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.
accompanying documents Adjustable DP-valves adopt international standards anti-siphon-device ASTM F catheter cerebro-spinal fluid CSF changed posture characteristics depend China China's degassed water differences and reasons drainage Drainage Drainage of cerebro-spinal Dynamic breaking strength flow characteristics flow direction flow rate flow-reducing following shall apply Gravitation valves hydrostatic devices implanted shunt included Inspection Center instructions intraventricular pressure Long term stability magnetic field manufacturer Medical Devices Product ml/h Non-active non-invasive Normative references opening pressure patient identification card peritoneum positive pressure pressure setting pressure-flow pressure/flow characteristics puncture radiopacity radiopaque range rate of 20 requirements for shunts requirements of YY/T Resistance to leakage showing the pressure/flow shunt are affected shunt is implanted shunts and components single-use hydrocephalus shunts specific Standard and ISO Sterile subcutaneous pressure Table NA.1 Technical differences Terms and Definitions tested and/or readjusted treatment of hydrocephalus type of valve valve performance ventricles ventriculo-atrial ventriculo-peritoneal water column X-ray image related