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ISO 8637-1:2017

ISO 8637-1:2017

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Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Published By Publication Date Number of Pages
ISO 2017-11 30
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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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ISO 8637-1:2017
$36.40