BS ISO 8637-3:2018 pdf free.Extracorporeal systems for blood purification Part 3: Plasmafilters. The performance characteristics specified in 4.3 shall be determined prior to marketing a new type of device and shall be re-evaluated after changes in the device that might alter its performance. The sample of device shall be drawn at random from the manufacturer’s production and shall have passed all applicable quality control steps, as well as sterilization. They shall be prepared according to the manufacturer’s recommendations as though they are to be used for a clinical procedure Measurements shall be made in vitro at (37 ± 1) °C. When the relationship between variables is nonlinear, sufficient determinations shall be made to permit interpolation between the data points. The techniques of measurement given in this document are reference tests. Other test methods may be used, provided they have been validated and shown to be precise and reproducible. The test systems shown do not indicate all the necessary details of practicable test apparatus. The design and construction of actual test systems and the establishment of actual test systems shall also address the many factors contributing to measurement error, including, but not limited to, pressure measurement errors due to static head…