Standard Swedish standard · SS-EN ISO 8637-2:2018

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

Status: Valid

Scope
This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — 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. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3. NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

Subjects

Transfusion, infusion and injection equipment (11.040.20) Implants for surgery, prosthetics and orthotics (11.040.40)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-80006322

Edition: 1

Approved: 8/27/2018

No of pages: 32

Replaces: SS-EN ISO 8638:2014