NEN-ISO 13960
Cardiovascular implants and extracorporeal systems - Plasmafilters
| Organization: | NEN |
| Publication Date: | 1 July 2010 |
| Status: | active |
| Page Count: | 18 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
This International Standard specifies requirements for sterile, single-use plasmafilters, intended for use on humans. This International Standard does not apply to the extracorporeal circuits used for plasmapheresis or other extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters, haemoperfusion devices, vascular access devices, oxygenators or active medical devices. This International Standard does not address the replacement fluid.
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