DS/EN ISO 8637-2:2018

Ekstrakorporale systemer til rensning af blod – Del 2: Ekstrakorporalt blodkredsløb ved hæmodialyse, hæmodiafiltrering og hæmofiltrering


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Kategori:
Pris fra:
kr. 555,00

Beskrivelse

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.


Antal sider: 32

Udgivet: 2018-08-30

Godkendelsesdato: 2018-08-28

Internationale relationer : EN ISO 8637-2:2018 IDT ISO 8637-2:2018 IDT

ICS: 11.040.40 - Implantater til kirurgi, protetik og ortoptik

Varenummer: M303549


Udvalg og komiteer

Komite

  • CEN/TC 205
  • ISO/TC 150/SC 2
  • ISO/TC 150/SC 2/WG 5

Dansk udvalg

DS/S-093