ISO 8637-1:2017

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

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.

Edition	2017
Standard Part No	1
Published Date	2017
Published By	International Standardization Organisation
Page Count	22