DS/EN ISO 8637-1:2020

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.64

Scope

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.


Number of pages: 34

Published: 2021-01-15

Date of approval: 2021-01-13

International relationships : EN ISO 8637-1:2020 IDT ISO 8637-1:2017 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M303548


Committees

Committee

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

Danish committee

DS/S-093