ISO 8637-3:2024
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Extracorporeal systems for blood purification — Part 3: Plasmafilters
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English
31-05-2024
This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to;
systems or equipment intended to perform plasma separation.
NOTE1 Requirements for the extracorporeal blood circuit are specified in ISO8637-2.
NOTE2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO8637-1.
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