EN ISO 8637-1:2020
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Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
04-15-2020
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.ISO 8637-1:2017 does not apply to:- extracorporeal blood circuits;- plasmafilters;- haemoperfusion devices;- vascular access devices;- blood pumps;- pressure monitors for the extracorporeal blood circuit;- air detection devices;- systems to prepare, maintain or monitor dialysis fluid;- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;- reprocessing procedures and equipment.NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.
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