BS EN ISO 8637-1:2020

This standard BS EN ISO 8637-1:2020 Extracorporeal systems for blood purification is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document 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.

WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document 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.